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NCT Number: NCT07268677

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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:

Tumor response evaluation will be performed after 4 treatment cycles.

Primary outcomes

ORR

Time frame: 3months

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.

Secondary outcomes

Overall survival

Time frame: 2years
Safety

Time frame: 6months

The severity of adverse events was determined using the NCI-CTC AE 5.0 standard. During the trial, the adverse event record form should be filled in truthfully, including the time of occurrence, severity, relevance to the study treatment, duration, measures taken, and outcome of the adverse event.

Sponsors and collaborators

Lead sponsor

Guoxiang Cai

Other

Registry information

Official study title

A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer Peritoneal Metastasis

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Dec 8, 2025
Registry last updated: Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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