RecruitingPhase 2NCT07085169

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study

Sponsor

Ruijin Hospital

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colo-rectal Cancer Bevacizumab Third-line and Beyond Therapy TAS 102

Summary

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a lower-dose combination of two chemotherapy drugs (trifluridine/tipiracil, also called TAS-102) plus bevacizumab (a drug that cuts off blood supply to tumors) in older adults with advanced colorectal cancer that has already received multiple prior treatments. **You may be eligible if...** - You are 60 years or older - You have been diagnosed with metastatic or advanced colorectal cancer (colon or rectal cancer that has spread) - You have already tried at least two chemotherapy regimens, or could not tolerate your last one - You are in reasonably good health (ECOG 0 to 2) with adequate blood and organ function **You may NOT be eligible if...** - Your cancer has spread to the brain - You have had a major surgery, serious infection, or heart event recently - You are pregnant or breastfeeding - You have uncontrolled high blood pressure or bleeding problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrifluridine/tipiracil (TAS-102) plus bevacizumab

Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.