A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Guoxiang Cai
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
