Status:
NOT_YET_RECRUITING
Efficacy and Safety of Trifluridine/tipiracil (TAS-102) Combined with Bevacizumab and Putalimab in the Treatment of Patients with MCRC After Cytoreductive Surgery: a Single-arm, Single-center Clinical Study
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietar...
Eligibility Criteria
Inclusion
- 1\. After complete cytoreduction surgery (CC0) for peritoneal metastasis of colorectal cancer;
- 2\. Patients diagnosed with peritoneal metastasis of colorectal cancer by pathology and imaging;
- 3\. Microsatellite stable (MSS) by genetic testing;
- 4\. Expected survival time at least 6 months;
- 5\. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
- 6\. Normal function of the heart, liver and kidneys;
- 7\. Normal hematological indicators: neutrophil count ≥1.5×109/L, white blood cell count (WBC) ≥3.0×109/L, hemoglobin ≥10g/dL, platelet count ≥100×109/L;
- 8\. Normal biochemical indicators: total bilirubin ≤1.5×upper limit of normal (ULN), AST and ALT ≤2.5 times upper limit of normal, serum creatinine and urea nitrogen (BUN) ≤1.5 times the upper limit of normal value;
Exclusion
- 1\. Unwilling to sign the informed consent form;
- 2\. Currently participating in interventional research treatment, or receiving other drugs or research devices within 4 weeks before enrollment;
- 3\. Having other malignant tumors at the same time;
- 4\. Other serious diseases that the investigators judge may affect follow-up and short-term survival;
- 5\. Allergic to TAS-102, bevacizumab or putelimab components;
- 6\. Uncontrolled brain metastases;
- 7\. Pregnant or lactating women;
- 8\. Those with a history of mental illness;
- 9\. Uncontrolled complications including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia;
- 10\. Severe coronary artery disease or cerebrovascular disease, or other diseases that the investigators believe are not suitable for enrollment;
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06882915
Start Date
May 1 2025
End Date
May 1 2027
Last Update
March 19 2025
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