Clinical Research Directory

KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

Sponsor: Peking Union Medical College Hospital

Summary

This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are: 1. Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment? 2. Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)? 3. What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location. Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis: 1. Change in LENT-SOMA rectal injury score (baseline vs. 3 months). 2. Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores. 3. Symptom improvement rate and time to complete remission. Participant will: 1. Undergo baseline and 3-month endoscopic evaluations. 2. Complete symptom diaries and quality-of-life questionnaires. 3. Attend regular clinic visits for safety monitoring.

Official title: KANGFUPEN (Liquid Dressing) for the Treatment of Chronic Radiation-Induced Rectal Injury: A Prospective, Single-Arm, Multicenter Study

Key Details

Conditions

Interventions

Locations (1)