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

NCT07268677 | Not Yet Recruiting Phase 2

• 1 other identifier: FDCRC0724
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR) or Partial Response (PR) during neoadjuvant therapy, as assessed by the investigator according to RECIST v1.1 criteria.

  3months

Secondary Outcomes (2)

• Overall survival

  2years

• Safety

  6months

Study Arms (1)

pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy

EXPERIMENTAL

Drug: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy

Interventions

pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy DRUG

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.

pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years;
• Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer;
• Planned to receive first-line chemotherapy;
• ECOG performance status of 0-1;
• Adequate hematologic, hepatic, and renal function:
• Neutrophil count ≥ 1.5 × 10⁹/L
• Platelet count ≥ 100 × 10⁹/L
• Hemoglobin ≥ 8.0 g/dL
• Creatinine clearance \> 30 mL/min
• For patients without liver metastasis: AST and ALT ≤ 2.5 × upper limit of normal (ULN)
• Total bilirubin ≤ 2 × ULN
• APTT and PT ≤ 1.5 × ULN

You may not qualify if:

• Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities;
• Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception;
• Expected survival ≤ 3 months;
• Participation in another investigational drug trial within the past 4 weeks;
• Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or immune checkpoint pathways);
• Uncontrolled neurological or psychiatric disorders that may affect compliance or the ability to report treatment responses;
• Known allergy to any study drug.

Sponsors & Collaborators

• Guoxiang Cai: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11