Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
- interventionNames
- Drug: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 3months
- description
- 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 (2)
- measure
- Overall survival
- timeFrame
- 2years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years; 2. Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer; 3. Planned to receive first-line chemotherapy; 4. ECOG performance status of 0-1; 5. Adequate hematologic, hepatic, and renal function: 1. Neutrophil count ≥ 1.5 × 10⁹/L 2. Platelet count ≥ 100 × 10⁹/L 3. Hemoglobin ≥ 8.0 g/dL 4. Creatinine clearance \> 30 mL/min 5. For patients without liver metastasis: AST and ALT ≤ 2.5 × upper limit of normal (ULN) 6. Total bilirubin ≤ 2 × ULN 7. APTT and PT ≤ 1.5 × ULN Exclusion Criteria: 1. Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities; 2. Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception; 3. Expected survival ≤ 3 months; 4. Participation in another investigational drug trial within the past 4 weeks; 5. 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); 6. Uncontrolled neurological or psychiatric disorders that may affect compliance or the ability to report treatment responses; 7. Known allergy to any study drug.
References
Publications (0)
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