A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 2years
|
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.
|
6months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDCRC0724
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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