A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Ne… (NCT07268677) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
30 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
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;
✕. 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;