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

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-02-01

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/m, IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m 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.

• Phase: PHASE2

Details

• Lead Sponsor: Guoxiang Cai
• Treatments: pirfenidone