A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.

Summary

Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required. Step 1: Ten patients will be initially enrolled. If the number of responders (CR/PR) is \< 2, the study will be terminated early for futility. If the number of responders is \> 8, the treatment regimen will be considered effective, and the study may be concluded early. Step 2: If the number of responders in Step 1 is between 2 and 8, the study will continue to enroll an additional 20 patients until completion. Treatment regimen: CapeOX + Pirfenidone + Sintilimab CapeOX: Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks Pirfenidone: Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen) Sintilimab: 200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply. Tumor response evaluation will be performed after 4 treatment cycles.

Timeline

Start

2025-12-01

Primary completion

2026-12-01

Completion

2027-02-01

Drugs

Indications