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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with metastatic colorectal cancer (mCRC) who have undergone surgery to remove tumors. The treatment being tested includes three medications: Trifluridine/tipiracil (TAS-102), which helps fight cancer; Bevacizumab, which prevents tumors from getting the blood supply they need to grow; and Putalimab, which boosts the body’s immune response against cancer cells. Researchers want to see if this combination is safe and effective for patients who have already had surgery and are dealing with cancer that has spread to other areas.

To participate in the trial, patients must have recently had successful surgery to remove tumors, be diagnosed with mCRC, and have certain health criteria met, such as having stable organ function and expected survival of at least six months. Patients will be monitored closely during the study to assess how well the treatment works and any side effects. This research is significant because it may lead to better treatment options for mCRC, helping to improve survival rates and quality of life for patients facing this challenging condition.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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;