KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

Baseline Assessments All enrolled patients must complete the following evaluations: 1. Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose) 2. Physical examination 3. ECOG performance status 4. Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers 5. Pelvic scans to exclude tumor recurrence/progression 6. Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally 7. Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria Treatment protocol Kangfupen (liquid dressing) retention enema * Dosage: 50 mL once daily for 3-6 months * Administration depth: Determined by colonoscopy findings Enema preparation \& administration 1. Reconstitution: 1. Transfer liquid from plastic to brown glass vial 2. Shake vigorously to dissolve lyophilized powder 3. Return solution to plastic bottle and shake again 2. Delivery: <!-- --> 1. Position: Left lateral decubitus with waste basin 2. Slowly instill 50 mL into rectum 3. Retain for ≥30 minutes, rotating positions every 15 minutes (left/right lateral, supine, knee-chest) Concomitant therapies Permitted: probiotics, smectite, antibiotics, stool softeners Prohibited: 5-ASA drugs (mesalazine/sulfasalazine), endoscopic hemostasis (e.g., argon plasma coagulation), formaldehyde/HBO/surgery/fecal microbiota transplant, other enema therapies. Toxicity monitoring Potential adverse events include allergic reactions and mechanical injury (bleeding/perforation). Required Actions include immediately discontinuing treatment and reporting to the principal investigating site within 24 hours. All adverse events will be assessed using CTCAE v5.0 criteria. Follow-up schedule Month 1-2: LENT-SOMA, RTOG/CTCAE grades, IBDQ, symptom improvement evaluation Month 3: Above + sigmoidoscopy with Vienna scoring Every 6 months after month 6: sigmoidoscopy + all scales + physician's global assessment of treatment efficacy