KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Kangfupen, a liquid dressing used as an enema, to help people who have long-lasting rectal damage caused by radiation therapy, often used for cancer in the pelvic area. The goal is to see if Kangfupen can reduce inflammation and improve symptoms like pain or bleeding over a few months of treatment, while also checking if it is safe to use. Researchers will look closely at changes in the rectal lining through special scopes and ask participants about their symptoms and quality of life before and after treatment.

People eligible for this study are adults aged 18 to 80 who have completed radiation treatment to the pelvic area at least three months ago and have signs of chronic radiation-related rectal injury confirmed by examination. Participants should be generally well enough to take part and not have other serious health problems or ongoing cancer treatments. If chosen, participants will receive Kangfupen once daily as an enema for 3 to 6 months, with regular check-ups, symptom diaries, and follow-up exams to monitor progress and safety. This study is not yet recruiting but aims to find a better way to manage this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fully voluntary with decision-making capacity
• • 18-80 years old
• • Completed pelvic radiotherapy for malignancy ≥3 months prior
• • Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2)
• • Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1)
• • No prior surgery
• • ECOG score 0-2
• • Estimated survival ≥1 year
• Exclusion Criteria:
• • Primary rectal tumours or pelvic malignancies with rectal involvement
• • Uncontrolled, recurrent, or metastatic tumours
• • Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties
• • Patients with intestinal fistula, perforation, or obstruction
• • History of electrocautery treatment within 1 month
• • Recent medication use (within 2 weeks): traditional Chinese medicine enemas, mesalazine (oral or rectal) and other anti-inflammatory bowel medications
• • History of superoxide dismutase allergy
• • Pre-existing chronic colitis, ulcerative colitis, or nonspecific proctitis
• • Connective tissue diseases requiring long-term corticosteroid therapy
• • Pregnant or lactating women
• • Active infection or fever
• • Other severe comorbidities potentially affecting trial compliance: unstable cardiac disease requiring treatment, renal disorders, chronic hepatitis, poorly controlled diabetes and psychiatric illnesses