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KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

NCT07065175 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

  • Chronic Radiation-induced Proctitis

Interventions

DRUG

Kangfupen (liquid dressing) retention enema administration

Dosage: 50 mL per administration, once daily Duration: 3-6 months of continuous therapy Procedure: Enema depth determined by colonoscopy-identified lesion location Administered as retention enema (minimum 30-minute retention time)

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Beijing Rectum Hospital

    collaborator UNKNOWN

  • Jilin City Hospital of Chemical Industry

    collaborator UNKNOWN

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07065175 on ClinicalTrials.gov