KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury
Status:
NOT_YET_RECRUITING
Trial end date:
2029-01-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Peking Union Medical College Hospital
Collaborators:
Beijing Rectum Hospital Jilin City Hospital of Chemical Industry Peking University First Hospital Sixth Affiliated Hospital, Sun Yat-sen University Tianjin Medical University Cancer Institute and Hospital