RARE DISEASE
Radiation proctitis
Radiation proctitis
Radiation proctitis
Drug discovery
2
drugs
With orphan designations
Overview
Radiation Proctitis
Radiation proctitis is rectal mucosal injury caused by pelvic radiation therapy, categorized into acute (during/within 3 months of treatment) and chronic (≥3 months post-treatment). Symptoms include diarrhea, rectal bleeding, urgency, and tenesmus. Chronic cases may lead to fibrosis, strictures, or fistulas. Management follows a stepwise approach, starting with anti-inflammatory agents and advancing to endoscopic or surgical interventions for refractory cases [1][5][8].
Therapies
Categories: rare disorders due to toxic effects, rare gastroenterological diseases
Research Papers
1,000 drug discovery papers about Radiation proctitis, with 1 first-in-class and 1 next-in-class emerging drug candidates forecasted to outperform the average preclinical success rate. Recent publications:
1,000 drug discovery papers about Radiation proctitis, with 1 first-in-class and 1 next-in-class emerging drug candidates forecasted to outperform the average preclinical success rate. Recent publications:
categories:
Small molecules
small molecules
2026-08-16 | Impact of Hydrogel Spacer on Radiation Proctitis After Prostate Cancer Radiation Therapy: A Large-Scale Claims Database Analysis.
We evaluated the real-world utility of hydrogel spacer placement for reducing radiation proctitis following prostate cancer radiation therapy using a large-scale claims database. We analyzed male patients from a Japanese administrative claims database (DeSC Database) who initiated primary radiation therapy between July 2018 and December 2024. Propensity score weighting using the average treatment effect on the treated method was applied to balance baseline characteristics between spacer users and nonusers. The primary endpoint was the occurrence of endoscopic gastrointestinal hemostasis, and the secondary endpoint was the diagnosis of radiation proctitis. Fine-Gray models were used to estimate subdistribution hazard ratios (sHRs) with death as a competing risk. Of 7860 eligible patients, 1754 (22.3%) underwent spacer placement. For the primary endpoint (endoscopic hemostasis), the spacer group showed a statistically significant lower risk (sHR 0.26; 95% CI, 0.10-0.69; P = .007). The cumulative incidence at 36 months was 0.8% in the spacer group versus 2.3% in the nonspacer group. For the secondary endpoint (diagnosed proctitis), the sHR was 0.29 (95% CI, 0.16-0.53; P < .001), with a 36-month cumulative incidence of 1.4% versus 4.8%, respectively. This large-scale real-world analysis demonstrates that hydrogel spacer placement is associated with a significantly lower incidence of severe radiation proctitis requiring endoscopic hemostasis.
2026-06-17 | Incidence and predictors of radiation proctitis or radiation cystitis after radiotherapy in patients with prostate cancer.
This study evaluated the cumulative incidences of radiation cystitis (RC) and radiation proctitis (RP) after radiotherapy (RT) for localised and metastatic prostate cancer (PCa). It also analysed potential risk factors associated with resultant emergency admissions. Between January 2001 and January 2023, 762 patients who underwent primary RT for localised PCa and low-volume metastatic hormone-sensitive PCa, as well as salvage or adjuvant RT after prostatectomy, were retrospectively analysed. The severities of RC and RP were assessed using the Common Terminology Criteria for Adverse Events version 5.0. Severe events were defined as grade 3 or higher. The median follow-up time was 59 months. The 5-year/10-year cumulative incidences of RC and severe RC were 11%/20% and 6.3%/12%, respectively. Among 58 patients with severe RC, 11 (19.0%) required endoscopic haemostasis. The 5-year/10-year cumulative incidences of RP and severe RP were 20%/21% and 7.5%/8.4%, respectively. Among 57 patients with severe RP, 38 (67%) required endoscopic haemostasis. Multivariable Cox regression analysis identified adjuvant or salvage RT as a predictor of RC; primary RT was identified as a predictor of RP. A bladder volume receiving >60 Gy of >25% was identified as a predictor of RC and severe RC. A rectal volume receiving >70 Gy of >10% was identified as a predictor of RP and severe RP. Antiplatelet medication was a significant risk factor for RC, RP, and severe events. Radiation cystitis and RP are common complications of RT in patients with PCa. Comprehensive counselling regarding these potential long-term adverse effects is imperative.
2026-05-03 | Temporal Patterns and Resolution of Toxicities Following Hypofractionated Salvage Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Hypofractionated salvage radiotherapy is increasingly used for biochemical recurrence of prostate cancer post-prostatectomy, yet its toxicity profile remains underexplored. This study evaluates the incidence, timing, and resolution of treatment-related toxicities in this setting. A retrospective cohort study of 403 men receiving hypofractionated salvage radiotherapy (62.5 Gy in 25 fractions) from 2017 to 2024 was conducted. Toxicities, categorized as genitourinary (hematuria, urinary incontinence, frequency, dysuria) or gastrointestinal (rectal bleeding, diarrhea, proctitis, nausea), were graded (1-3) using CTCAE-based criteria. Outcomes included any-time incidence, Kaplan-Meier time-to-first-event estimates (12- and 24-month cumulative incidence), and first-onset timing. Episode-level analyses merged events ≤ 30 days apart, assessing resolution and intervention. Median follow-up was 18.2 months. Any-grade genitourinary and gastrointestinal toxicities occurred in 34.2% and 24.6% of patients, respectively (24-month incidence: genitourinary 40.4%; gastrointestinal 28.9%). Grade 2+ toxicities were less frequent (genitourinary 9.7%; gastrointestinal 7.7%), with Grade 3+ rare (genitourinary 1.7%; gastrointestinal 0.7%). In terms of patient-level ever-event incidences, common symptoms included urinary incontinence (20.3%), rectal bleeding (19.9%), and hematuria (13.9%). Urinary toxicities predominantly onset at 6-12 months, whereas rectal bleeding and hematuria emerged later (≥ 12 months). Approximately two-thirds of Grade 2+ episodes resolved (e.g., urinary incontinence, 66.7%; rectal bleeding, 69.2%), with median resolution times of 3.0-8.4 months. With a median follow-up of 18.2 months, hypofractionated salvage radiotherapy demonstrates favorable short-to-intermediate term tolerability, with infrequent severe toxicities. Vigilant monitoring for late-onset rectal bleeding and hematuria is recommended during the 6-24 months after treatment to optimize patient management. Longer follow-up is required to confirm long-term safety.
2026-04-24 | Treatment-Related Adverse Effects
1. Radiation therapy is a crucial treatment method for various cancers, used alone or with chemotherapy and surgery. 2. Radiation-Induced Oral Mucositis (RIOM) is the most common and significant side effect, which worsens with higher doses delivered over a shorter period of time. 3. Radiation Proctitis is a common side effect, characterized by inflammation of the rectal mucosa due to radiation. Acute proctitis usually appears within three months of starting therapy and can last up to six months, potentially progressing to chronic proctitis after therapy. 4. Acute Radiation-Induced Esophagitis (ARIE) symptoms usually arise within the first two months of radiotherapy and adversely affect the quality of life, often causing unplanned pauses in treatment and lessening therapy effectiveness. 5. Radiation-induced pneumonitis is a significant concern in patients receiving radiation for lung, breast, and lymphoma cancers, and in those undergoing total body irradiation for bone marrow transplants with systemic glucocorticoids being the preferred treatment that can lead to symptom relief and radiographic improvement although relapse is possible post-treatment.
2026-04-20 | Metformin and butyrate attenuate chronic radiation proctitis by alleviating inflammation and macrophage senescence.
Chronic radiation proctitis (RP) is characterized by persistent inflammation and impaired tissue repair. This study investigates the potential of a metformin-butyrate (MeBu) combination to modulate radiation-induced senescence-associated changes in macrophages to mitigate chronic injury. BALB/c mice received a 15 Gy fraction of rectal brachytherapy. From weeks 4 to 8 post-irradiation, mice were treated with rectal enemas of metformin, butyrate, or the MeBu combination. Tissue histology (H&E and Masson's Trichrome staining), macrophage polarization (iNOS/CD163) were evaluated. Effects on senescence markers were analyzed in irradiated bone marrow-derived macrophages (BMDMs) using SA-β-gal staining and qPCR for p16 and p21. A composite Senescence Burden Index (SBI) was developed to integrate transcriptional senescence signals. MeBu treatment was associated with a reduction in mucosal fibrosis and a phenotypic shift in macrophages toward a more reparative M2-like profile (increased CD163/iNOS ratio). In BMDMs, MeBu significantly reduced SA-β-Gal positivity and suppressed p21 expression (p = 0.0074), with a downward trend in p16 (p = 0.0568). The integrated SBI demonstrated that MeBu significantly attenuated the overall senescence burden compared to the irradiated group (p < 0.01). This combined effect was more robust than that of either metformin or butyrate alone. Our findings suggest that the MeBu combination may attenuate chronic RP by modulating macrophage-associated senescence and inflammation. These results indicate that metabolic-based senomorphic strategies hold potential to mitigate chronic inflammatory sequelae following pelvic radiotherapy.
proteins
2025-10-01 | S1407 Implementation of PuraStat for the Treatment of Radiation Proctitis
Introduction: Radiation proctitis is a common adverse effect of radiation therapy and significantly impacts quality of life. Many patients are managed with traditional hemostatic modalities such as Argon Plasma Coagulation (APC) with varying rates of symptomatic control (54% to 97%). In prior observational studies, serious complications, such as perforation or fistulation, requiring surgical intervention were reported in 6% to 13% of patients. Since 2014, topical self-assembling peptides (TSAP) have been widely adopted as a safe agent for hemostatic control in gastrointestinal bleeding (GIB); however, there is limited literature on the use of TSAP alone or in combination with APC to treat radiation proctitis. Methods: This is a retrospective observational study of a single tertiary cancer care center, from July 2022 to February 2025, of patients with a confirmed diagnosis of radiation proctitis who were treated with TSAP for symptomatic management. Results: Among 332 patients who received TSAP treatment during the study window, 17 met inclusion criteria (76% White; 41% woman; median age 75 years); 100% reported bloody stool as the predominant symptom. Neovascularization was the most frequent finding on endoscopy (71%) and 9 patients (53%) had active bleeding during endoscopy. Four patients (24%) received TSAP monotherapy while 76% achieved hemostasis in combination with APC. Eighty-two percent of patients achieved symptomatic remission after treatment though 24% reported symptomatic recurrence at a median of 72 days after initial intervention. TSAP monotherapy appeared to have higher efficacy (100% vs 83%), but higher recurrence (50% vs 17%) compared to combination regimen with shorter median period until symptomatic recurrence (38 days vs 96.5 days). Eight patients (47%) underwent subsequent surveillance colonoscopy with 75% receiving additional TSAP. None of the patients experienced serious complications associated with treatment that required surgical intervention during the study period. Conclusion: PuraStat is a promising, safe modality for the treatment of radiation proctitis associated GIB at high efficacy but high recurrence. The combination of TSAP with APC could serve as efficacious treatment with presumed expedited mucosal healing, durable effect and minimal serious complications. Further research is needed to determine the efficacy of TSAP monotherapy and in combination with APC for short-term symptom management and long-term mucosal healing of radiation-induced proctitis.
2025-03-17 | Self-Assembling Hemostatic Peptide Gel Used to Successfully Treat Rectal Ulcer in Radiation-Associated Vascular Ectasia: A Case Report.
BACKGROUND Radiation-associated vascular ectasia, formerly known as radiation proctitis, is a known gastrointestinal complication of radiation therapy. Rectal ulcers in the setting of radiation-associated vascular ectasia are particularly challenging to treat. They are often refractory to conventional medical and endoscopic therapies and cause significant morbidity for patients. Self-assembling hemostatic peptide gel is an endoscopic tool used primarily for hemostasis but has also been hypothesized to have mucosal repair properties. CASE REPORT A 41-year-old woman with a history of cervical adenocarcinoma presented with abdominal pain and rectal bleeding several months after brachytherapy and external beam radiation therapy. Conservative therapy with topical pramoxine was ineffective, so she underwent colonoscopy, which revealed a non-bleeding rectal ulcer in the setting of bleeding radiation-associated vascular ectasia. Argon plasma coagulation was used to treat the bleeding vascular ectasia, but the ulcer was treated solely with self-assembling hemostatic peptide gel. A follow-up endoscopy two months later showed complete resolution of the ulcer. CONCLUSIONS The mucosal repair properties of the self-assembling hemostatic peptide gel, an endoscopic product initially designed for hemostasis, are highlighted by this case in which a non-hemorrhagic ulcer was successfully treated. Furthermore, this is a novel use of the self-assembling hemostatic peptide gel in the setting of radiation-associated vascular ectasia and may represent a useful addition to the endoscopist's toolkit for managing a challenging condition.
2023-10-15 | Use of botulinum toxin in the management of radiotherapy side effects
Many experimental and clinical studies are conducted to investigate the effects of various applications of botulinum toxin (BTx) in the treatment of radiation related side effects. There are no studies that show clear results about the positive and negative effects of its active clinical use in the long run, and discussions are ongoing. In addition, there is a need for various researches about how BTx can be used and how long it can be used, and the side effects it may cause. BTx-A, which is one of the options in the treatment of side effects that will occur due to radiotherapy, is an effective and safe option. Applying BTx injection to the right place with specific injection methods increases the effectiveness and safety of the treatment.It has been investigated whether BTx will be a potential tool to perfect the esthetic and functional results in reducing the chronic side effects associated with radiotherapy.
2023-05-12 | Emergency Endoscopic Hemostasis for Gastrointestinal Bleeding Using a Self-Assembling Peptide: A Case Series
Background and Objectives: A novel synthetic self-assembling peptide, PuraStat, has been introduced as a hemostatic agent. This case series aimed to evaluate the clinical efficacy of PuraStat for gastrointestinal bleeding during emergency endoscopy. Cases: Twenty-five patients with gastrointestinal bleeding who had undergone emergency endoscopy with PuraStat between August 2021 and December 2022 were retrospectively examined. Six patients were receiving antithrombotic agents, and ten patients with refractory gastrointestinal bleeding had undergone at least one endoscopic hemostatic procedure. The breakdown of bleeding was gastroduodenal ulcer/erosion in 12 cases, bleeding after gastroduodenal or colorectal endoscopic resection in 4 cases, rectal ulcer in 2 cases, postoperative anastomotic ulcer in 2 cases, and gastric cancer, diffuse antral vascular ectasia, small intestinal ulcer, colonic diverticular bleeding, and radiation proctitis in each case. The method of hemostasis was only PuraStat application in six cases, and hemostasis in combination with high-frequency hemostatic forceps, hemostatic clip, argon plasma coagulation, and hemostatic agents (i.e., thrombin) in the remaining cases. Rebleeding was observed in three cases. Hemostatic efficiency was observed in 23 cases (92%). Conclusions: PuraStat has the expected hemostatic effect on gastrointestinal bleeding during emergency endoscopy. The use of PuraStat should be considered in emergency endoscopic hemostasis of gastrointestinal bleeding.
2023-03-27 | Emergency Endoscopic Haemostasis for Gastrointestinal Bleeding using A Self-Assembling Peptide: A Case Series
Background and Objectives: A novel synthetic self-assembling peptide, PuraStat, has been introduced as a hemostatic agent. This case series aimed to evaluate the clinical efficacy of PuraStat for gastrointestinal bleeding during emergency endoscopy. Cases: Twenty-five patients with gastrointestinal bleeding who had undergone emergency endoscopy with PuraStat between August 2021 and December 2022 were retrospectively examined. Six patients were receiving antithrombotic agent, and ten patients with refractory gastrointestinal bleeding had undergone at least one endoscopic hemostatic procedure. The breakdown of bleeding was gastroduodenal ulcer/erosion in 12 cases, bleeding after gastroduodenal or colorectal endoscopic resection in 4 cases, rectal ulcer in 2 cases, postoperative anastomotic ulcer in 2 cases, and gastric cancer, diffuse antral vascular ectasia, small intestinal ulcer, colonic diverticular bleeding, and radiation proctitis in each case. The method of hemostasis was only PuraStat application in six cases, and hemostasis in combination with high-frequency hemostatic forceps, hemostatic clip, argon plasma coagulation, and hemostatic agents (i.e. thrombin) in the remaining cases. Rebleeding was observed in three cases. Hemostatic efficiency was observed in 23 cases (92%). Conclusions: PuraStat has the expected hemostatic effect on gastrointestinal bleeding during emergency endoscopy. The use of PuraStat should be considered in emergency endoscopic hemostasis of gastrointestinal bleeding.
cell therapies
2026-07-28 | Microbiota-nutrition sequential therapy for refractory radiation proctitis: A case report
BACKGROUNDGut dysbiosis is closely associated with radiation-induced intestinal injury.This study aimed to preliminarily assess the efficacy and safety of fecal microbiota transplantation (FMT) combined with immunomodulatory enteral nutrition (IEN) for the treatment of refractory radiation proctitis. CASE SUMMARYA 49-year-old woman with prior cervical cancer treated by hysterectomy 4 years earlier presented with left inguinal lymphadenopathy.Following radiotherapy, the patient experienced lower abdominal pain, diarrhea, and hematochezia, diagnosed as radiation enteritis.The patient underwent two FMT with adjunctive IEN support.Symptoms alleviated from Common Terminology Criteria for Adverse Events grade 3 proctitis to grade 2 after the first FMT, and further to grade 1 after the second.Nutritional and immune indices improved obviously: Body mass index (20.28kg/m²→24.34kg/m²), total protein (63.7 g/L→73.7 g/L), albumin (35.8 g/L→40 g/L), lymphocyte count (0.94× 10 9 /L→1.37 × 10 9 /L) and lymphocyte percentage (18.2%→34.8%)rose, while procalcitonin dropped from 0.07 ng/mL to 0.03 ng/mL.The Vienna Rectoscopy Score declined from 25 to 16 post-FMT1 and 5 post-FMT2.Pro-inflammatory cytokines tumor necrosis factor-α (2.29 pg/mL→1.51pg/mL), interferon (IFN)-γ (0.73 pg/mL→0.16pg/mL) and interleukin (IL)-6 (9.40 pg/mL→3.60 pg/mL) decreased significantly, while anti-inflammatory IL-4 (0.97 pg/mL→1.16pg/mL) and IL-10 (0.70 pg/mL→0.86 pg/mL) slightly increased.IL-2 and IL-1β rose mildly, and IL-8 elevated moderately.Sequential FMT restored gut Shannon diversity; principal coordinates analysis verified microbiota remodeling close to donor profiles, with reduced Escherichia-Shigella and enriched beneficial genera Faecalibacterium, Bacteroides and Ruminococcus. CONCLUSION 4 / 31In this patient, FMT combined with immunomodulatory nutrition was associated with restoration of gut microbiota, alleviation of symptoms, and improvement in nutritional and immune parameters in refractory radiation proctitis, suggesting a potential therapeutic strategy that warrants further validation.
2025-08-20 | Multi-function of adipose-derived stem cells on gut disorder: from bench to bedside.
Adipose-derived stem cells (ADSCs) are a specific type of mesenchymal stem cells (MSCs) obtained easily from adipose tissue (AT). Compared with MSCs, ADSCs are easier to obtain, have fewer ethical issues, and have a higher proliferative capacity, which makes them a promising type of stem cell in regenerative medicine. ADSCs possess impressive capabilities in cell regeneration as well as differentiation, making them promising candidates for injury repair, tissue regeneration and alleviation of inflamed tissues. At present, most clinical studies on ADSCs focus on the treatment of wounds, multiple sclerosis, soft tissue trauma, aging, diabetes, Parkinson’s disease, bone and cartilage regeneration, stroke, and spinal cord injury, while its clinical applications in the gastrointestinal tract are relatively few. Therefore, this review summarizes the findings of preclinical experiments, clinical trials, and areas that may require further development of ADSCs in the treatment of digestive disorders, including inflammatory bowel disease (IBD), colorectal cancer (CRC), colorectal fibrosis, hepatocellular carcinoma, hepatic fibrosis, gastric cancer (GC), gastrostomy closure and radiation-induced proctitis. The review is concluded by discussing the goals for improvement and future directions for ADSCs before large-scale clinical application. [Image: see text]
2024-11-13 | Management of radiation-induced proctitis using submucosal endoscopic injections of autologous adipose-derived stromal vascular fraction: a case report.
Standard approaches to the treatment of chronic post-radiation proctitis are associated with a high risk of complications and a high percentage of unsatisfactory results due to the reduced regenerative potential of irradiated tissues. Regenerative surgery techniques using the stromal-vascular cell fraction (SVF) based on the patient's autologous adipose tissue are a promising direction for study. A 76-year-old patient suffering from chronic post-radiation erosive-ulcerative proctitis, grade 4 according to RTOG-EORTC, complicated by recurrent profuse rectal bleeding, underwent local autotransplantation of SVF into the submucosal layer of the rectum and pararectal connective tissue. The follow-up colonoscopies 1 and 6 months after the surgery and histological examination showed the complete epithelialization of ulcerative defects and a decrease in proctitis activity. There were no bleeding episodes during the 12-month postoperative observation period. The proangiogenic, wound-healing, and anti-apoptotic effects of the SVF cell suspension provided reduction of inflammation activity, epithelialization of ulcers, and elimination of defecation-associated hemorrhage, following the SVF injection into the submucosal layer of the rectal wall and pararectal connective tissue in a patient with post-radiation proctitis with ulcers and recurrent bleeding.
2023-12-01 | USING AUTOLOGOUS MICROFRAGMENTED ADIPOSE TISSUE IN THE TREATMENT OF RADIATION-INDUCED ULCERATIVE PROCTITIS
Abstract. Introduction. Radiation-induced ulcerative proctitis is a serious complication of cancer radiotherapy for prostate, cervix, uterine body, anal canal, and other pelvic tumors. Given the development pattern, there are currently no pathogenetic methods for the treatment of radiation-induced ulcerative proctitis. Aim: To develop a technique for and evaluate its effectiveness in the treatment of patients with radiation-induced rectal ulcers using autologous microfragmented adipose tissue. Materials and Methods. The study included 30 patients, of which 24 (80.0%) were women and 6 (20.0%) were men. Manual lipoaspiration was used to obtain autologous adipose tissue. Then we performed its microfragmentation via transfers. Concentrated autologous adipose tissue was introduced into the edges of the radiation-induced ulcerative defect on the rectal wall under endoscopic control. При контрольной ректоскопии через 6 месяцев у 28 (93,3 %) пациентов была отмечена полная эпителизация постлучевых язвенных дефек- тов прямой кишки. Results and Discussion. The manipulation, from sampling the adipose tissue through the end of injection lasted a little more than an hour (Me = 75.0 min). No intraoperative complications were detected. In one female patient (3.3%), a local recurrence of cervical cancer was found, and therefore that patient was excluded from the study. Control rectoscopy showed the complete epithelialization of post-radiation ulcerative rectal defects in 28 (93.3%) patients after 6 months. Conclusions. The technique proposed to use autologous microfragmented adipose tissue is affordable and effective in the treatment of patients with radiation-induced ulcerative proctitis.
2023-06-01 | APPLICATION OF AUTOLOGICAL MICROFRAGMENTED ADIPOSE TISSUE IN THE TREATMENT OF POST-RADIATION ULCERATIVE PROCTITIS
Introduction. Post-radiation ulcerative proctitis is a serious complication after radiotherapy for cancer of the prostate, cervix and uterine body, anal canal, and other pelvic tumors. Given the mechanism of occurrence, there are currently no pathogenetic methods for the treatment of post-radiation ulcerative proctitis. Aim. Is to develop a technique and evaluate its effectiveness in the treatment of patients with post-radiation rectal ulcers using autologous microfragmented adipose tissue. Material and methods. The study included 30 patients, of which 24 (80.0% were women and 6 (20.0%) were men. Manual lipoaspiration was used to obtain autologous adipose tissue. Then, microfragmentation was performed through transfers. The introduction of autologous concentrated adipose tissue was performed in edges of post-radiation ulcerative defect of the rectal wall under endoscopic control. Results and discussion. The duration of the manipulation from the moment of adipose tissue sampling to the end of the injection was a little more than an hour (Me = 75.0 min). No intraoperative complications were identified. One patient (3.3%) had a local recurrence of cervical cancer, and therefore the patient was excluded from the study. Control rectoscopy after 6 months in 28 (93.3%) patients showed complete epithelialization of post-radiation ulcerative defects of the rectum. Conclusion. The technique of using autologous microfragmented adipose tissue is affordable and effective in the treatment of patients with post-radiation ulcerative proctitis
antibodies
2026-06-10 | Single cells and spatial RNA profiling reveal that inflammatory fibroblasts arise from Edil3 stromal cells in the colon after irradiation.
Patients with cancer who are treated for tumors located in the abdominopelvic region may develop radiation proctitis. This condition is characterized by severe mucosal inflammation that can significantly impair quality of life. In the colon, it's now established that the stroma orchestrates epithelial, endothelial, and immune cell homeostasis and plays a pivotal role following an injury. A more comprehensive understanding of the underlying mechanisms responsible for digestive mucosa injury and regeneration processes would enable therapeutic targets to be identified for limiting or even treating digestive lesions caused by radiotherapy. In this work, single-cell RNA sequencing was combined with spatial transcriptomics (ST) for an in-depth characterization of colonic stromal cells, highlighting their heterogeneity, their specific functions and interactions in homeostasis, and changes they undergo following localized colon irradiation. The present study identifies the Edil3 marker, (EGF-like repeats and discoidin domains 3), that distinguishes the most abundant stromal population, alongside the previously characterized trophocytes and telocytes. We propose the term "mesitocytes", from the ancient Greek "mesítês" ("intermediary"), for this stromal subtype, in accordance with both their position along the crypt axis and their role in the BMP/Wnt gradient. After irradiation, we demonstrate the deregulation of the stromal compartment, with an increase of genes involved in immune response, angiogenesis, and regenerative epithelial process. Specifically in the ulcerated area, Edil3 mesitocytes and telocytes are no longer detected by ST. Instead, inflammation-associated fibroblasts (IAFs) emerge, characterized by a distinct transcriptomic signature, including Ereg, Igfbp5, Il11 and C3. This feature is substantiated by analysis of human transcriptomic data which underscores the significance of our findings. Cell fate analysis further clarifies the origins of IAFs, identifying Edil3 mesitocytes as their main source. Furthermore, we observe that IAFs cooperate with endothelial cells, and we also demonstrate IAF-specific molecules involvement in epithelial disruption and endothelial activation, suggesting their key role in disease progression.
2026-01-10 | Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): A phase II trial.
119 Background: PD-1 inhibitor shows poor efficacy in MSS locally advanced rectal cancer (LARC). Radiotherapy activates tumor immunogenicity, and current evidence have shown that combination of neoadjuvant chemoradiotherapy (nCRT) with PD-1 inhibitor enhances tumor regression and improves pathological complete response (pCR) rate in MSS LARC. However, nCRT induces radiation toxicities including radiation proctitis, anastomotic fistula and anal dysfunction. Moreover, radiotherapy is not feasible for high position LARC. Radiotherapy-free neoadjuvant strategy warrants further exploration. Neoadjuvant mFOLFOX6 circumvents radiation toxicity but achieves only 6.6% pCR rate (FOWARC trial, JCO 2016). Preclinical studies suggested oxaliplatin and 5FU have immune-sensitizing effects. Thus, we conducted the first proof of concept trial exploring a radiotherapy-free neoadjuvant immuno-chemotherapy (nICT) regimen, which employed a multicenter, single arm, phase 2 design to evaluate the efficacy and safety of mFOLFOX6 plus serplulimab in MSS/pMMR LARC. Methods: Patients (pts) with cT3/4 or cN+, MSS and pMMR LARC located ≤15 cm from anal verge were eligible. Pts received 6 cycles of neoadjuvant mFOLFOX6 and serplulimab, followed by surgery and adjuvant mFOLFOX6. The primary endpoints were pCR rate and major pathological response (MPR) rate. Enrollment of 30 pts was planned, with hypothesis of an increased pCR of 24% compared with reported data of 6.6% after conventional mFOLFOX6. The per-protocol set (PPS) was defined as pts who completed ≥4 cycles of nICT for primary endpoint assessment. Results: Among 30 enrolled patients, 28 completed ≥4 cycles of nICT and were included in PPS. 2 discontinued due to adverse events. The pCR was achieved in 42.9% (12/28) of pts, and MPR in 67.9% (19/28). For high LARC (>10 cm from anal verge, ineligible for nCRT), the pCR and MPR rates were 71.4% and 85.7%. Radiologic response of tumor regression showed complete response in 57.1% (16/28) and partial response in 39.3% (11/28) of pts. One pt had stable disease and received nCRT. 27 pts proceeded to TME and were included in surgical set. TRG 0, 1, 2, and 3 were observed in 44.4%, 11.1%, 40.7%, and 3.7% of pts. Downstaging was achieved in 22 pts (81.5%). The Grade 3 TRAEs were lymphocyte decrease (4 pts), neutropenia (3 pts) and bilirubin elevation (1 pts). No Grade 4-5 TRAEs or anastomotic fistula were observed. Conclusions: mFOLFOX6 plus serplulimab showed promising efficacy and manageable safety in MSS LARC. pCR rate unexpectedly reached 42.9%, showing an improvement compared with the reported 6.6% pCR rate of chemotherapy, and were comparable to nCRT plus anti-PD-1 regimens. This is the first proof of concept trial to explore a nICT strategy for MSS LARC, which spares pts from radiation toxicities and shows particularly applicability for high LARC. We are launching a randomized controlled trial (FIRM02) for further validation. Clinical trial information: NCT06688786 .
2021-11-29 | [Interpretation of Chinese expert consensus on multidisciplinary diagnosis and treatment of radiation rectal injury (2021 edition)].
Although pelvic radiotherapy has played an important role in the treatment of malignant tumors, it is still difficult to avoid radiation damage within a certain period of time. In 2021, under the joint promotion of Colorectal Surgery Group of Chinese Medical Association Surgery Branch, Colorectal Surgeons Committee of Chinese Medical Doctor Association Surgeons Branch, Colorectal Surgeons Committee of Chinese Medical Doctor Association, and Colorectal Cancer Professional Committee of Chinese Anti-Cancer Association, Expert Group on Diagnosis and Treatment of Radiation Intestinal Injury has updated and formulated the 2021 edition of the "Chinese expert consensus on the multidisciplinary diagnosis and treatment of radiation rectal injury" (hereinafter referred to as "Consensus"). This Consensus edition has major changes compared with the "Chinese consensus on the diagnosis and treatment of radiation proctitis (2018)", which mainly updates in the following aspects: (1) adjusting the name of radiation rectal injury: the term "radiation proctitis" was adjusted to "radiation rectal injury"; (2) advocating the concept of pelvic integral injury and the multidisciplinary diagnosis and treatment model; (3) putting forward the clinical classification of diseases: the classification of the chronic rectal injury includes telangiectasia, ulcer, stenosis and mixed type; (4) carrying out individualized treatment based on the characteristics of the above-mentioned disease classification, and adjusting the recommended level of non-surgical treatment; (5) proposing specific guiding principles and details of surgical treatment: "damage control" and "expanded resection" principles, etc. This new edition (2021) of Consensus further refines the disease analysis and treatment strategies, which not only improves the guiding value of clinical practice, but also provides an important reference for the standardized diagnosis and treatment of radiation rectal injury in China. 盆腔放疗在恶性肿瘤治疗过程中发挥了重要作用，但仍难以避免造成放射性损伤。2021年，在中华医学会外科学分会结直肠外科学组、中国医师协会外科医师分会结直肠外科医师委员会和中国抗癌协会大肠癌专业委员会的共同推动下，放射性肠损伤诊治专家组更新制订了2021版《中国放射性直肠损伤多学科诊治专家共识》（以下简称"共识"）。与《中国放射性直肠炎诊治专家共识（2018版）》相比，该版本有较大的改动，更新主要体现在以下几个方面：（1）调整放射性直肠损伤名称：将"放射性直肠炎"这一称谓调整为"放射性直肠损伤"；（2）倡导盆腔整体性损伤概念和多学科诊治模式；（3）提出疾病临床分型：慢性期损伤分型包括毛细血管扩张型、溃疡型、狭窄型和混合型；（4）根据上述疾病分型特点进行个体化治疗，并调整非手术治疗的推荐等级；（5）提出手术治疗的具体指导原则与细节："损伤控制"原则和"扩大切除"原则等方面。新版"共识"对疾病分析及治疗策略等进一步细化，提高了临床实践指导价值，为我国放射性直肠损伤的规范化诊治提供了重要参考依据。.
2015-10-26 | Prospective phase II trial of nimotuzumab in combination with radiotherapy and concurrent capecitabine in locally advanced rectal cancer.
The aim of the study was to evaluate the safety and efficacy of adding concurrent nimotuzumab to preoperative radiotherapy with concurrent capecitabine in locally advanced rectal cancer. Patients with rectal cancer (clinical stage T3/4 or N+) were scheduled to receive weekly nimotuzumab (400 mg; days -6, 1, 8, 15, 22, and 29). Capecitabine (825 mg/m(2)) was delivered orally twice daily for the duration of radiotherapy. Radiotherapy was administered at 50.4 Gy (45 + 5.4 Gy). The main endpoint was the pathologic complete response (pCR) rate. Twenty-one patients with T3 or T4 disease were enrolled; 66.7 % were nodal-positive; the median distance from the anal verge was 5.5 cm. A pCR was achieved in four patients (19.0 %); 71.4 % patients obtained moderate or good tumor regression (Grade 2 and 3). Downstaging occurred in 15/21 (71.4 %) patients by T stage and 11/14 (78.6 %) by N stage. The actual dose intensities (median/mean, %) were nimotuzumab (100, 100) and capecitabine (100, 99.5). The most frequent Grade 1/2 toxicities were radiation dermatitis (57.1 %), nausea/vomiting (52.4 %), leukocytopenia (47.6 %), diarrhea (47.6 %), and proctitis (38.1 %). Grade 3 diarrhea was observed in 9.5 % of patients and Grade 3 leukocytopenia in 4.8 %. These preliminary results indicate that nimotuzumab can be safely combined with radiotherapy plus concurrent capecitabine. The efficacy of this regimen (pCR = 19.0 %) was significantly higher than that observed in previous phase II trials of preoperative radiotherapy with concurrent capecitabine and cetuximab in rectal cancer. Further investigation of concurrent nimotuzumab with radiotherapy plus capecitabine is warranted.
2009-03-01 | The Effect of AlloDerm Envelopes on Periprosthetic Capsule Formation with and without Radiation
Background: The pathobiology of radiation-induced periprosthetic capsular formation and factors that may ameliorate its development have not been fully elucidated. The authors hypothesized that AlloDerm would diminish radiation-induced capsular formation. Methods: Two 5-ml implants were placed submuscularly in the backs of 41 rats. The right implant was wrapped with AlloDerm and the left remained bare. After 48 hours, 20 animals underwent irradiation to each implant, and 21 animals underwent no further treatment and served as controls. After 3 and 12 weeks, the capsules were harvested and submitted for tensile strength and histologic examination. Intraprosthetic pressures were measured in each implant at the time of surgery and when the animals were killed. Results: The intraprosthetic pressure decrease was uniform among all groups at 3 and 12 weeks. Between 3 and 12 weeks, capsular tensile strength increased in nonirradiated bare implants. There was considerable invasion of nonirradiated AlloDerm by inflammatory infiltrates at 3 weeks, and AlloDerm thickness decreased over time. Cellular invasion of AlloDerm was decreased with irradiation at both time points. Capsular tensile strength and thickness of the irradiated bare and AlloDerm capsules did not change between 3 and 12 weeks. Radiation increased inflammation of bare capsules at 12 weeks, but it was significantly reduced in irradiated AlloDerm capsules. The majority of irradiated bare capsules developed pseudoepithelium, whereas AlloDerm protected capsules from this transformation. Conclusion: AlloDerm decreases radiation-related inflammation and delays or diminishes pseudoepithelium formation and thus may slow progression of capsular formation, fibrosis, and contraction.
small molecules
2026-08-16 | Impact of Hydrogel Spacer on Radiation Proctitis After Prostate Cancer Radiation Therapy: A Large-Scale Claims Database Analysis.
We evaluated the real-world utility of hydrogel spacer placement for reducing radiation proctitis following prostate cancer radiation therapy using a large-scale claims database. We analyzed male patients from a Japanese administrative claims database (DeSC Database) who initiated primary radiation therapy between July 2018 and December 2024. Propensity score weighting using the average treatment effect on the treated method was applied to balance baseline characteristics between spacer users and nonusers. The primary endpoint was the occurrence of endoscopic gastrointestinal hemostasis, and the secondary endpoint was the diagnosis of radiation proctitis. Fine-Gray models were used to estimate subdistribution hazard ratios (sHRs) with death as a competing risk. Of 7860 eligible patients, 1754 (22.3%) underwent spacer placement. For the primary endpoint (endoscopic hemostasis), the spacer group showed a statistically significant lower risk (sHR 0.26; 95% CI, 0.10-0.69; P = .007). The cumulative incidence at 36 months was 0.8% in the spacer group versus 2.3% in the nonspacer group. For the secondary endpoint (diagnosed proctitis), the sHR was 0.29 (95% CI, 0.16-0.53; P < .001), with a 36-month cumulative incidence of 1.4% versus 4.8%, respectively. This large-scale real-world analysis demonstrates that hydrogel spacer placement is associated with a significantly lower incidence of severe radiation proctitis requiring endoscopic hemostasis.
2026-06-17 | Incidence and predictors of radiation proctitis or radiation cystitis after radiotherapy in patients with prostate cancer.
This study evaluated the cumulative incidences of radiation cystitis (RC) and radiation proctitis (RP) after radiotherapy (RT) for localised and metastatic prostate cancer (PCa). It also analysed potential risk factors associated with resultant emergency admissions. Between January 2001 and January 2023, 762 patients who underwent primary RT for localised PCa and low-volume metastatic hormone-sensitive PCa, as well as salvage or adjuvant RT after prostatectomy, were retrospectively analysed. The severities of RC and RP were assessed using the Common Terminology Criteria for Adverse Events version 5.0. Severe events were defined as grade 3 or higher. The median follow-up time was 59 months. The 5-year/10-year cumulative incidences of RC and severe RC were 11%/20% and 6.3%/12%, respectively. Among 58 patients with severe RC, 11 (19.0%) required endoscopic haemostasis. The 5-year/10-year cumulative incidences of RP and severe RP were 20%/21% and 7.5%/8.4%, respectively. Among 57 patients with severe RP, 38 (67%) required endoscopic haemostasis. Multivariable Cox regression analysis identified adjuvant or salvage RT as a predictor of RC; primary RT was identified as a predictor of RP. A bladder volume receiving >60 Gy of >25% was identified as a predictor of RC and severe RC. A rectal volume receiving >70 Gy of >10% was identified as a predictor of RP and severe RP. Antiplatelet medication was a significant risk factor for RC, RP, and severe events. Radiation cystitis and RP are common complications of RT in patients with PCa. Comprehensive counselling regarding these potential long-term adverse effects is imperative.
2026-05-03 | Temporal Patterns and Resolution of Toxicities Following Hypofractionated Salvage Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Hypofractionated salvage radiotherapy is increasingly used for biochemical recurrence of prostate cancer post-prostatectomy, yet its toxicity profile remains underexplored. This study evaluates the incidence, timing, and resolution of treatment-related toxicities in this setting. A retrospective cohort study of 403 men receiving hypofractionated salvage radiotherapy (62.5 Gy in 25 fractions) from 2017 to 2024 was conducted. Toxicities, categorized as genitourinary (hematuria, urinary incontinence, frequency, dysuria) or gastrointestinal (rectal bleeding, diarrhea, proctitis, nausea), were graded (1-3) using CTCAE-based criteria. Outcomes included any-time incidence, Kaplan-Meier time-to-first-event estimates (12- and 24-month cumulative incidence), and first-onset timing. Episode-level analyses merged events ≤ 30 days apart, assessing resolution and intervention. Median follow-up was 18.2 months. Any-grade genitourinary and gastrointestinal toxicities occurred in 34.2% and 24.6% of patients, respectively (24-month incidence: genitourinary 40.4%; gastrointestinal 28.9%). Grade 2+ toxicities were less frequent (genitourinary 9.7%; gastrointestinal 7.7%), with Grade 3+ rare (genitourinary 1.7%; gastrointestinal 0.7%). In terms of patient-level ever-event incidences, common symptoms included urinary incontinence (20.3%), rectal bleeding (19.9%), and hematuria (13.9%). Urinary toxicities predominantly onset at 6-12 months, whereas rectal bleeding and hematuria emerged later (≥ 12 months). Approximately two-thirds of Grade 2+ episodes resolved (e.g., urinary incontinence, 66.7%; rectal bleeding, 69.2%), with median resolution times of 3.0-8.4 months. With a median follow-up of 18.2 months, hypofractionated salvage radiotherapy demonstrates favorable short-to-intermediate term tolerability, with infrequent severe toxicities. Vigilant monitoring for late-onset rectal bleeding and hematuria is recommended during the 6-24 months after treatment to optimize patient management. Longer follow-up is required to confirm long-term safety.
2026-04-24 | Treatment-Related Adverse Effects
1. Radiation therapy is a crucial treatment method for various cancers, used alone or with chemotherapy and surgery. 2. Radiation-Induced Oral Mucositis (RIOM) is the most common and significant side effect, which worsens with higher doses delivered over a shorter period of time. 3. Radiation Proctitis is a common side effect, characterized by inflammation of the rectal mucosa due to radiation. Acute proctitis usually appears within three months of starting therapy and can last up to six months, potentially progressing to chronic proctitis after therapy. 4. Acute Radiation-Induced Esophagitis (ARIE) symptoms usually arise within the first two months of radiotherapy and adversely affect the quality of life, often causing unplanned pauses in treatment and lessening therapy effectiveness. 5. Radiation-induced pneumonitis is a significant concern in patients receiving radiation for lung, breast, and lymphoma cancers, and in those undergoing total body irradiation for bone marrow transplants with systemic glucocorticoids being the preferred treatment that can lead to symptom relief and radiographic improvement although relapse is possible post-treatment.
2026-04-20 | Metformin and butyrate attenuate chronic radiation proctitis by alleviating inflammation and macrophage senescence.
Chronic radiation proctitis (RP) is characterized by persistent inflammation and impaired tissue repair. This study investigates the potential of a metformin-butyrate (MeBu) combination to modulate radiation-induced senescence-associated changes in macrophages to mitigate chronic injury. BALB/c mice received a 15 Gy fraction of rectal brachytherapy. From weeks 4 to 8 post-irradiation, mice were treated with rectal enemas of metformin, butyrate, or the MeBu combination. Tissue histology (H&E and Masson's Trichrome staining), macrophage polarization (iNOS/CD163) were evaluated. Effects on senescence markers were analyzed in irradiated bone marrow-derived macrophages (BMDMs) using SA-β-gal staining and qPCR for p16 and p21. A composite Senescence Burden Index (SBI) was developed to integrate transcriptional senescence signals. MeBu treatment was associated with a reduction in mucosal fibrosis and a phenotypic shift in macrophages toward a more reparative M2-like profile (increased CD163/iNOS ratio). In BMDMs, MeBu significantly reduced SA-β-Gal positivity and suppressed p21 expression (p = 0.0074), with a downward trend in p16 (p = 0.0568). The integrated SBI demonstrated that MeBu significantly attenuated the overall senescence burden compared to the irradiated group (p < 0.01). This combined effect was more robust than that of either metformin or butyrate alone. Our findings suggest that the MeBu combination may attenuate chronic RP by modulating macrophage-associated senescence and inflammation. These results indicate that metabolic-based senomorphic strategies hold potential to mitigate chronic inflammatory sequelae following pelvic radiotherapy.
proteins
2025-10-01 | S1407 Implementation of PuraStat for the Treatment of Radiation Proctitis
Introduction: Radiation proctitis is a common adverse effect of radiation therapy and significantly impacts quality of life. Many patients are managed with traditional hemostatic modalities such as Argon Plasma Coagulation (APC) with varying rates of symptomatic control (54% to 97%). In prior observational studies, serious complications, such as perforation or fistulation, requiring surgical intervention were reported in 6% to 13% of patients. Since 2014, topical self-assembling peptides (TSAP) have been widely adopted as a safe agent for hemostatic control in gastrointestinal bleeding (GIB); however, there is limited literature on the use of TSAP alone or in combination with APC to treat radiation proctitis. Methods: This is a retrospective observational study of a single tertiary cancer care center, from July 2022 to February 2025, of patients with a confirmed diagnosis of radiation proctitis who were treated with TSAP for symptomatic management. Results: Among 332 patients who received TSAP treatment during the study window, 17 met inclusion criteria (76% White; 41% woman; median age 75 years); 100% reported bloody stool as the predominant symptom. Neovascularization was the most frequent finding on endoscopy (71%) and 9 patients (53%) had active bleeding during endoscopy. Four patients (24%) received TSAP monotherapy while 76% achieved hemostasis in combination with APC. Eighty-two percent of patients achieved symptomatic remission after treatment though 24% reported symptomatic recurrence at a median of 72 days after initial intervention. TSAP monotherapy appeared to have higher efficacy (100% vs 83%), but higher recurrence (50% vs 17%) compared to combination regimen with shorter median period until symptomatic recurrence (38 days vs 96.5 days). Eight patients (47%) underwent subsequent surveillance colonoscopy with 75% receiving additional TSAP. None of the patients experienced serious complications associated with treatment that required surgical intervention during the study period. Conclusion: PuraStat is a promising, safe modality for the treatment of radiation proctitis associated GIB at high efficacy but high recurrence. The combination of TSAP with APC could serve as efficacious treatment with presumed expedited mucosal healing, durable effect and minimal serious complications. Further research is needed to determine the efficacy of TSAP monotherapy and in combination with APC for short-term symptom management and long-term mucosal healing of radiation-induced proctitis.
2025-03-17 | Self-Assembling Hemostatic Peptide Gel Used to Successfully Treat Rectal Ulcer in Radiation-Associated Vascular Ectasia: A Case Report.
BACKGROUND Radiation-associated vascular ectasia, formerly known as radiation proctitis, is a known gastrointestinal complication of radiation therapy. Rectal ulcers in the setting of radiation-associated vascular ectasia are particularly challenging to treat. They are often refractory to conventional medical and endoscopic therapies and cause significant morbidity for patients. Self-assembling hemostatic peptide gel is an endoscopic tool used primarily for hemostasis but has also been hypothesized to have mucosal repair properties. CASE REPORT A 41-year-old woman with a history of cervical adenocarcinoma presented with abdominal pain and rectal bleeding several months after brachytherapy and external beam radiation therapy. Conservative therapy with topical pramoxine was ineffective, so she underwent colonoscopy, which revealed a non-bleeding rectal ulcer in the setting of bleeding radiation-associated vascular ectasia. Argon plasma coagulation was used to treat the bleeding vascular ectasia, but the ulcer was treated solely with self-assembling hemostatic peptide gel. A follow-up endoscopy two months later showed complete resolution of the ulcer. CONCLUSIONS The mucosal repair properties of the self-assembling hemostatic peptide gel, an endoscopic product initially designed for hemostasis, are highlighted by this case in which a non-hemorrhagic ulcer was successfully treated. Furthermore, this is a novel use of the self-assembling hemostatic peptide gel in the setting of radiation-associated vascular ectasia and may represent a useful addition to the endoscopist's toolkit for managing a challenging condition.
2023-10-15 | Use of botulinum toxin in the management of radiotherapy side effects
Many experimental and clinical studies are conducted to investigate the effects of various applications of botulinum toxin (BTx) in the treatment of radiation related side effects. There are no studies that show clear results about the positive and negative effects of its active clinical use in the long run, and discussions are ongoing. In addition, there is a need for various researches about how BTx can be used and how long it can be used, and the side effects it may cause. BTx-A, which is one of the options in the treatment of side effects that will occur due to radiotherapy, is an effective and safe option. Applying BTx injection to the right place with specific injection methods increases the effectiveness and safety of the treatment.It has been investigated whether BTx will be a potential tool to perfect the esthetic and functional results in reducing the chronic side effects associated with radiotherapy.
2023-05-12 | Emergency Endoscopic Hemostasis for Gastrointestinal Bleeding Using a Self-Assembling Peptide: A Case Series
Background and Objectives: A novel synthetic self-assembling peptide, PuraStat, has been introduced as a hemostatic agent. This case series aimed to evaluate the clinical efficacy of PuraStat for gastrointestinal bleeding during emergency endoscopy. Cases: Twenty-five patients with gastrointestinal bleeding who had undergone emergency endoscopy with PuraStat between August 2021 and December 2022 were retrospectively examined. Six patients were receiving antithrombotic agents, and ten patients with refractory gastrointestinal bleeding had undergone at least one endoscopic hemostatic procedure. The breakdown of bleeding was gastroduodenal ulcer/erosion in 12 cases, bleeding after gastroduodenal or colorectal endoscopic resection in 4 cases, rectal ulcer in 2 cases, postoperative anastomotic ulcer in 2 cases, and gastric cancer, diffuse antral vascular ectasia, small intestinal ulcer, colonic diverticular bleeding, and radiation proctitis in each case. The method of hemostasis was only PuraStat application in six cases, and hemostasis in combination with high-frequency hemostatic forceps, hemostatic clip, argon plasma coagulation, and hemostatic agents (i.e., thrombin) in the remaining cases. Rebleeding was observed in three cases. Hemostatic efficiency was observed in 23 cases (92%). Conclusions: PuraStat has the expected hemostatic effect on gastrointestinal bleeding during emergency endoscopy. The use of PuraStat should be considered in emergency endoscopic hemostasis of gastrointestinal bleeding.
2023-03-27 | Emergency Endoscopic Haemostasis for Gastrointestinal Bleeding using A Self-Assembling Peptide: A Case Series
Background and Objectives: A novel synthetic self-assembling peptide, PuraStat, has been introduced as a hemostatic agent. This case series aimed to evaluate the clinical efficacy of PuraStat for gastrointestinal bleeding during emergency endoscopy. Cases: Twenty-five patients with gastrointestinal bleeding who had undergone emergency endoscopy with PuraStat between August 2021 and December 2022 were retrospectively examined. Six patients were receiving antithrombotic agent, and ten patients with refractory gastrointestinal bleeding had undergone at least one endoscopic hemostatic procedure. The breakdown of bleeding was gastroduodenal ulcer/erosion in 12 cases, bleeding after gastroduodenal or colorectal endoscopic resection in 4 cases, rectal ulcer in 2 cases, postoperative anastomotic ulcer in 2 cases, and gastric cancer, diffuse antral vascular ectasia, small intestinal ulcer, colonic diverticular bleeding, and radiation proctitis in each case. The method of hemostasis was only PuraStat application in six cases, and hemostasis in combination with high-frequency hemostatic forceps, hemostatic clip, argon plasma coagulation, and hemostatic agents (i.e. thrombin) in the remaining cases. Rebleeding was observed in three cases. Hemostatic efficiency was observed in 23 cases (92%). Conclusions: PuraStat has the expected hemostatic effect on gastrointestinal bleeding during emergency endoscopy. The use of PuraStat should be considered in emergency endoscopic hemostasis of gastrointestinal bleeding.
cell therapies
2026-07-28 | Microbiota-nutrition sequential therapy for refractory radiation proctitis: A case report
BACKGROUNDGut dysbiosis is closely associated with radiation-induced intestinal injury.This study aimed to preliminarily assess the efficacy and safety of fecal microbiota transplantation (FMT) combined with immunomodulatory enteral nutrition (IEN) for the treatment of refractory radiation proctitis. CASE SUMMARYA 49-year-old woman with prior cervical cancer treated by hysterectomy 4 years earlier presented with left inguinal lymphadenopathy.Following radiotherapy, the patient experienced lower abdominal pain, diarrhea, and hematochezia, diagnosed as radiation enteritis.The patient underwent two FMT with adjunctive IEN support.Symptoms alleviated from Common Terminology Criteria for Adverse Events grade 3 proctitis to grade 2 after the first FMT, and further to grade 1 after the second.Nutritional and immune indices improved obviously: Body mass index (20.28kg/m²→24.34kg/m²), total protein (63.7 g/L→73.7 g/L), albumin (35.8 g/L→40 g/L), lymphocyte count (0.94× 10 9 /L→1.37 × 10 9 /L) and lymphocyte percentage (18.2%→34.8%)rose, while procalcitonin dropped from 0.07 ng/mL to 0.03 ng/mL.The Vienna Rectoscopy Score declined from 25 to 16 post-FMT1 and 5 post-FMT2.Pro-inflammatory cytokines tumor necrosis factor-α (2.29 pg/mL→1.51pg/mL), interferon (IFN)-γ (0.73 pg/mL→0.16pg/mL) and interleukin (IL)-6 (9.40 pg/mL→3.60 pg/mL) decreased significantly, while anti-inflammatory IL-4 (0.97 pg/mL→1.16pg/mL) and IL-10 (0.70 pg/mL→0.86 pg/mL) slightly increased.IL-2 and IL-1β rose mildly, and IL-8 elevated moderately.Sequential FMT restored gut Shannon diversity; principal coordinates analysis verified microbiota remodeling close to donor profiles, with reduced Escherichia-Shigella and enriched beneficial genera Faecalibacterium, Bacteroides and Ruminococcus. CONCLUSION 4 / 31In this patient, FMT combined with immunomodulatory nutrition was associated with restoration of gut microbiota, alleviation of symptoms, and improvement in nutritional and immune parameters in refractory radiation proctitis, suggesting a potential therapeutic strategy that warrants further validation.
2025-08-20 | Multi-function of adipose-derived stem cells on gut disorder: from bench to bedside.
Adipose-derived stem cells (ADSCs) are a specific type of mesenchymal stem cells (MSCs) obtained easily from adipose tissue (AT). Compared with MSCs, ADSCs are easier to obtain, have fewer ethical issues, and have a higher proliferative capacity, which makes them a promising type of stem cell in regenerative medicine. ADSCs possess impressive capabilities in cell regeneration as well as differentiation, making them promising candidates for injury repair, tissue regeneration and alleviation of inflamed tissues. At present, most clinical studies on ADSCs focus on the treatment of wounds, multiple sclerosis, soft tissue trauma, aging, diabetes, Parkinson’s disease, bone and cartilage regeneration, stroke, and spinal cord injury, while its clinical applications in the gastrointestinal tract are relatively few. Therefore, this review summarizes the findings of preclinical experiments, clinical trials, and areas that may require further development of ADSCs in the treatment of digestive disorders, including inflammatory bowel disease (IBD), colorectal cancer (CRC), colorectal fibrosis, hepatocellular carcinoma, hepatic fibrosis, gastric cancer (GC), gastrostomy closure and radiation-induced proctitis. The review is concluded by discussing the goals for improvement and future directions for ADSCs before large-scale clinical application. [Image: see text]
2024-11-13 | Management of radiation-induced proctitis using submucosal endoscopic injections of autologous adipose-derived stromal vascular fraction: a case report.
Standard approaches to the treatment of chronic post-radiation proctitis are associated with a high risk of complications and a high percentage of unsatisfactory results due to the reduced regenerative potential of irradiated tissues. Regenerative surgery techniques using the stromal-vascular cell fraction (SVF) based on the patient's autologous adipose tissue are a promising direction for study. A 76-year-old patient suffering from chronic post-radiation erosive-ulcerative proctitis, grade 4 according to RTOG-EORTC, complicated by recurrent profuse rectal bleeding, underwent local autotransplantation of SVF into the submucosal layer of the rectum and pararectal connective tissue. The follow-up colonoscopies 1 and 6 months after the surgery and histological examination showed the complete epithelialization of ulcerative defects and a decrease in proctitis activity. There were no bleeding episodes during the 12-month postoperative observation period. The proangiogenic, wound-healing, and anti-apoptotic effects of the SVF cell suspension provided reduction of inflammation activity, epithelialization of ulcers, and elimination of defecation-associated hemorrhage, following the SVF injection into the submucosal layer of the rectal wall and pararectal connective tissue in a patient with post-radiation proctitis with ulcers and recurrent bleeding.
2023-12-01 | USING AUTOLOGOUS MICROFRAGMENTED ADIPOSE TISSUE IN THE TREATMENT OF RADIATION-INDUCED ULCERATIVE PROCTITIS
Abstract. Introduction. Radiation-induced ulcerative proctitis is a serious complication of cancer radiotherapy for prostate, cervix, uterine body, anal canal, and other pelvic tumors. Given the development pattern, there are currently no pathogenetic methods for the treatment of radiation-induced ulcerative proctitis. Aim: To develop a technique for and evaluate its effectiveness in the treatment of patients with radiation-induced rectal ulcers using autologous microfragmented adipose tissue. Materials and Methods. The study included 30 patients, of which 24 (80.0%) were women and 6 (20.0%) were men. Manual lipoaspiration was used to obtain autologous adipose tissue. Then we performed its microfragmentation via transfers. Concentrated autologous adipose tissue was introduced into the edges of the radiation-induced ulcerative defect on the rectal wall under endoscopic control. При контрольной ректоскопии через 6 месяцев у 28 (93,3 %) пациентов была отмечена полная эпителизация постлучевых язвенных дефек- тов прямой кишки. Results and Discussion. The manipulation, from sampling the adipose tissue through the end of injection lasted a little more than an hour (Me = 75.0 min). No intraoperative complications were detected. In one female patient (3.3%), a local recurrence of cervical cancer was found, and therefore that patient was excluded from the study. Control rectoscopy showed the complete epithelialization of post-radiation ulcerative rectal defects in 28 (93.3%) patients after 6 months. Conclusions. The technique proposed to use autologous microfragmented adipose tissue is affordable and effective in the treatment of patients with radiation-induced ulcerative proctitis.
2023-06-01 | APPLICATION OF AUTOLOGICAL MICROFRAGMENTED ADIPOSE TISSUE IN THE TREATMENT OF POST-RADIATION ULCERATIVE PROCTITIS
Introduction. Post-radiation ulcerative proctitis is a serious complication after radiotherapy for cancer of the prostate, cervix and uterine body, anal canal, and other pelvic tumors. Given the mechanism of occurrence, there are currently no pathogenetic methods for the treatment of post-radiation ulcerative proctitis. Aim. Is to develop a technique and evaluate its effectiveness in the treatment of patients with post-radiation rectal ulcers using autologous microfragmented adipose tissue. Material and methods. The study included 30 patients, of which 24 (80.0% were women and 6 (20.0%) were men. Manual lipoaspiration was used to obtain autologous adipose tissue. Then, microfragmentation was performed through transfers. The introduction of autologous concentrated adipose tissue was performed in edges of post-radiation ulcerative defect of the rectal wall under endoscopic control. Results and discussion. The duration of the manipulation from the moment of adipose tissue sampling to the end of the injection was a little more than an hour (Me = 75.0 min). No intraoperative complications were identified. One patient (3.3%) had a local recurrence of cervical cancer, and therefore the patient was excluded from the study. Control rectoscopy after 6 months in 28 (93.3%) patients showed complete epithelialization of post-radiation ulcerative defects of the rectum. Conclusion. The technique of using autologous microfragmented adipose tissue is affordable and effective in the treatment of patients with post-radiation ulcerative proctitis
antibodies
2026-06-10 | Single cells and spatial RNA profiling reveal that inflammatory fibroblasts arise from Edil3 stromal cells in the colon after irradiation.
Patients with cancer who are treated for tumors located in the abdominopelvic region may develop radiation proctitis. This condition is characterized by severe mucosal inflammation that can significantly impair quality of life. In the colon, it's now established that the stroma orchestrates epithelial, endothelial, and immune cell homeostasis and plays a pivotal role following an injury. A more comprehensive understanding of the underlying mechanisms responsible for digestive mucosa injury and regeneration processes would enable therapeutic targets to be identified for limiting or even treating digestive lesions caused by radiotherapy. In this work, single-cell RNA sequencing was combined with spatial transcriptomics (ST) for an in-depth characterization of colonic stromal cells, highlighting their heterogeneity, their specific functions and interactions in homeostasis, and changes they undergo following localized colon irradiation. The present study identifies the Edil3 marker, (EGF-like repeats and discoidin domains 3), that distinguishes the most abundant stromal population, alongside the previously characterized trophocytes and telocytes. We propose the term "mesitocytes", from the ancient Greek "mesítês" ("intermediary"), for this stromal subtype, in accordance with both their position along the crypt axis and their role in the BMP/Wnt gradient. After irradiation, we demonstrate the deregulation of the stromal compartment, with an increase of genes involved in immune response, angiogenesis, and regenerative epithelial process. Specifically in the ulcerated area, Edil3 mesitocytes and telocytes are no longer detected by ST. Instead, inflammation-associated fibroblasts (IAFs) emerge, characterized by a distinct transcriptomic signature, including Ereg, Igfbp5, Il11 and C3. This feature is substantiated by analysis of human transcriptomic data which underscores the significance of our findings. Cell fate analysis further clarifies the origins of IAFs, identifying Edil3 mesitocytes as their main source. Furthermore, we observe that IAFs cooperate with endothelial cells, and we also demonstrate IAF-specific molecules involvement in epithelial disruption and endothelial activation, suggesting their key role in disease progression.
2026-01-10 | Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): A phase II trial.
119 Background: PD-1 inhibitor shows poor efficacy in MSS locally advanced rectal cancer (LARC). Radiotherapy activates tumor immunogenicity, and current evidence have shown that combination of neoadjuvant chemoradiotherapy (nCRT) with PD-1 inhibitor enhances tumor regression and improves pathological complete response (pCR) rate in MSS LARC. However, nCRT induces radiation toxicities including radiation proctitis, anastomotic fistula and anal dysfunction. Moreover, radiotherapy is not feasible for high position LARC. Radiotherapy-free neoadjuvant strategy warrants further exploration. Neoadjuvant mFOLFOX6 circumvents radiation toxicity but achieves only 6.6% pCR rate (FOWARC trial, JCO 2016). Preclinical studies suggested oxaliplatin and 5FU have immune-sensitizing effects. Thus, we conducted the first proof of concept trial exploring a radiotherapy-free neoadjuvant immuno-chemotherapy (nICT) regimen, which employed a multicenter, single arm, phase 2 design to evaluate the efficacy and safety of mFOLFOX6 plus serplulimab in MSS/pMMR LARC. Methods: Patients (pts) with cT3/4 or cN+, MSS and pMMR LARC located ≤15 cm from anal verge were eligible. Pts received 6 cycles of neoadjuvant mFOLFOX6 and serplulimab, followed by surgery and adjuvant mFOLFOX6. The primary endpoints were pCR rate and major pathological response (MPR) rate. Enrollment of 30 pts was planned, with hypothesis of an increased pCR of 24% compared with reported data of 6.6% after conventional mFOLFOX6. The per-protocol set (PPS) was defined as pts who completed ≥4 cycles of nICT for primary endpoint assessment. Results: Among 30 enrolled patients, 28 completed ≥4 cycles of nICT and were included in PPS. 2 discontinued due to adverse events. The pCR was achieved in 42.9% (12/28) of pts, and MPR in 67.9% (19/28). For high LARC (>10 cm from anal verge, ineligible for nCRT), the pCR and MPR rates were 71.4% and 85.7%. Radiologic response of tumor regression showed complete response in 57.1% (16/28) and partial response in 39.3% (11/28) of pts. One pt had stable disease and received nCRT. 27 pts proceeded to TME and were included in surgical set. TRG 0, 1, 2, and 3 were observed in 44.4%, 11.1%, 40.7%, and 3.7% of pts. Downstaging was achieved in 22 pts (81.5%). The Grade 3 TRAEs were lymphocyte decrease (4 pts), neutropenia (3 pts) and bilirubin elevation (1 pts). No Grade 4-5 TRAEs or anastomotic fistula were observed. Conclusions: mFOLFOX6 plus serplulimab showed promising efficacy and manageable safety in MSS LARC. pCR rate unexpectedly reached 42.9%, showing an improvement compared with the reported 6.6% pCR rate of chemotherapy, and were comparable to nCRT plus anti-PD-1 regimens. This is the first proof of concept trial to explore a nICT strategy for MSS LARC, which spares pts from radiation toxicities and shows particularly applicability for high LARC. We are launching a randomized controlled trial (FIRM02) for further validation. Clinical trial information: NCT06688786 .
2021-11-29 | [Interpretation of Chinese expert consensus on multidisciplinary diagnosis and treatment of radiation rectal injury (2021 edition)].
Although pelvic radiotherapy has played an important role in the treatment of malignant tumors, it is still difficult to avoid radiation damage within a certain period of time. In 2021, under the joint promotion of Colorectal Surgery Group of Chinese Medical Association Surgery Branch, Colorectal Surgeons Committee of Chinese Medical Doctor Association Surgeons Branch, Colorectal Surgeons Committee of Chinese Medical Doctor Association, and Colorectal Cancer Professional Committee of Chinese Anti-Cancer Association, Expert Group on Diagnosis and Treatment of Radiation Intestinal Injury has updated and formulated the 2021 edition of the "Chinese expert consensus on the multidisciplinary diagnosis and treatment of radiation rectal injury" (hereinafter referred to as "Consensus"). This Consensus edition has major changes compared with the "Chinese consensus on the diagnosis and treatment of radiation proctitis (2018)", which mainly updates in the following aspects: (1) adjusting the name of radiation rectal injury: the term "radiation proctitis" was adjusted to "radiation rectal injury"; (2) advocating the concept of pelvic integral injury and the multidisciplinary diagnosis and treatment model; (3) putting forward the clinical classification of diseases: the classification of the chronic rectal injury includes telangiectasia, ulcer, stenosis and mixed type; (4) carrying out individualized treatment based on the characteristics of the above-mentioned disease classification, and adjusting the recommended level of non-surgical treatment; (5) proposing specific guiding principles and details of surgical treatment: "damage control" and "expanded resection" principles, etc. This new edition (2021) of Consensus further refines the disease analysis and treatment strategies, which not only improves the guiding value of clinical practice, but also provides an important reference for the standardized diagnosis and treatment of radiation rectal injury in China. 盆腔放疗在恶性肿瘤治疗过程中发挥了重要作用，但仍难以避免造成放射性损伤。2021年，在中华医学会外科学分会结直肠外科学组、中国医师协会外科医师分会结直肠外科医师委员会和中国抗癌协会大肠癌专业委员会的共同推动下，放射性肠损伤诊治专家组更新制订了2021版《中国放射性直肠损伤多学科诊治专家共识》（以下简称"共识"）。与《中国放射性直肠炎诊治专家共识（2018版）》相比，该版本有较大的改动，更新主要体现在以下几个方面：（1）调整放射性直肠损伤名称：将"放射性直肠炎"这一称谓调整为"放射性直肠损伤"；（2）倡导盆腔整体性损伤概念和多学科诊治模式；（3）提出疾病临床分型：慢性期损伤分型包括毛细血管扩张型、溃疡型、狭窄型和混合型；（4）根据上述疾病分型特点进行个体化治疗，并调整非手术治疗的推荐等级；（5）提出手术治疗的具体指导原则与细节："损伤控制"原则和"扩大切除"原则等方面。新版"共识"对疾病分析及治疗策略等进一步细化，提高了临床实践指导价值，为我国放射性直肠损伤的规范化诊治提供了重要参考依据。.
2015-10-26 | Prospective phase II trial of nimotuzumab in combination with radiotherapy and concurrent capecitabine in locally advanced rectal cancer.
The aim of the study was to evaluate the safety and efficacy of adding concurrent nimotuzumab to preoperative radiotherapy with concurrent capecitabine in locally advanced rectal cancer. Patients with rectal cancer (clinical stage T3/4 or N+) were scheduled to receive weekly nimotuzumab (400 mg; days -6, 1, 8, 15, 22, and 29). Capecitabine (825 mg/m(2)) was delivered orally twice daily for the duration of radiotherapy. Radiotherapy was administered at 50.4 Gy (45 + 5.4 Gy). The main endpoint was the pathologic complete response (pCR) rate. Twenty-one patients with T3 or T4 disease were enrolled; 66.7 % were nodal-positive; the median distance from the anal verge was 5.5 cm. A pCR was achieved in four patients (19.0 %); 71.4 % patients obtained moderate or good tumor regression (Grade 2 and 3). Downstaging occurred in 15/21 (71.4 %) patients by T stage and 11/14 (78.6 %) by N stage. The actual dose intensities (median/mean, %) were nimotuzumab (100, 100) and capecitabine (100, 99.5). The most frequent Grade 1/2 toxicities were radiation dermatitis (57.1 %), nausea/vomiting (52.4 %), leukocytopenia (47.6 %), diarrhea (47.6 %), and proctitis (38.1 %). Grade 3 diarrhea was observed in 9.5 % of patients and Grade 3 leukocytopenia in 4.8 %. These preliminary results indicate that nimotuzumab can be safely combined with radiotherapy plus concurrent capecitabine. The efficacy of this regimen (pCR = 19.0 %) was significantly higher than that observed in previous phase II trials of preoperative radiotherapy with concurrent capecitabine and cetuximab in rectal cancer. Further investigation of concurrent nimotuzumab with radiotherapy plus capecitabine is warranted.
2009-03-01 | The Effect of AlloDerm Envelopes on Periprosthetic Capsule Formation with and without Radiation
Background: The pathobiology of radiation-induced periprosthetic capsular formation and factors that may ameliorate its development have not been fully elucidated. The authors hypothesized that AlloDerm would diminish radiation-induced capsular formation. Methods: Two 5-ml implants were placed submuscularly in the backs of 41 rats. The right implant was wrapped with AlloDerm and the left remained bare. After 48 hours, 20 animals underwent irradiation to each implant, and 21 animals underwent no further treatment and served as controls. After 3 and 12 weeks, the capsules were harvested and submitted for tensile strength and histologic examination. Intraprosthetic pressures were measured in each implant at the time of surgery and when the animals were killed. Results: The intraprosthetic pressure decrease was uniform among all groups at 3 and 12 weeks. Between 3 and 12 weeks, capsular tensile strength increased in nonirradiated bare implants. There was considerable invasion of nonirradiated AlloDerm by inflammatory infiltrates at 3 weeks, and AlloDerm thickness decreased over time. Cellular invasion of AlloDerm was decreased with irradiation at both time points. Capsular tensile strength and thickness of the irradiated bare and AlloDerm capsules did not change between 3 and 12 weeks. Radiation increased inflammation of bare capsules at 12 weeks, but it was significantly reduced in irradiated AlloDerm capsules. The majority of irradiated bare capsules developed pseudoepithelium, whereas AlloDerm protected capsules from this transformation. Conclusion: AlloDerm decreases radiation-related inflammation and delays or diminishes pseudoepithelium formation and thus may slow progression of capsular formation, fibrosis, and contraction.
Access all drug discovery papers and probability of success in trials forecasts:
Access all drug discovery papers and probability of success in trials forecasts:
Drug Discovery Landscape
2 orphan drug designations for Radiation proctitis.
2 orphan drug designations for Radiation proctitis.
Drug | Therapy type | Regulator | Orphan designation | Approval | Sponsor |
|---|---|---|---|---|---|
Sodium butyrate (rectal use) | small molecules | EMA | 2005-05-27 | — | Promefarm srl |
Short chain fatty acid enema | small molecules | FDA | 1997-08-19 | — | Richard I. Breuer, M.D. |
Let's accelerate rare disease drug discovery
Let's accelerate drug discovery
Get access to Explority AI’s forecasts to outperform average preclinical success rates. Whether you’re expanding your R&D pipeline, evaluating a partnership, or simply have a question — we’d love to hear from you.