Low-dose TrifluridineTipiracil Combined With Bevacizumab for Patients Over 60 With Refractory Metastatic Colorectal Cancer in a Phase 2 Study

What this Trial Is About

Researchers are evaluating a modified low-dose regimen of trifluridinetipiracil combined with bevacizumab for patients with metastatic colorectal cancer that no longer responds to standard treatments. This phase II, single-center study aims to assess the effectiveness and safety of this treatment approach, addressing concerns about toxicity from standard doses. Participants will have previously received at least two chemotherapy regimens or been intolerant to them. The treatment involves taking trifluridinetipiracil orally at 17.5 mgm2 twice daily for 10 days, followed by 4 days off, in a 14-day cycle. Bevacizumab is given intravenously at 5 mgkg on day 1 of each cycle, also every 14 days. This combined treatment will continue until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo regular assessments to monitor disease progression and side effects. The main outcome measured is the progression-free survival rate at 6 months. Secondary outcomes include tracking adverse events, objective response rate up to 16 weeks, overall progression-free survival up to 60 months, and overall survival up to 100 months. Participants are monitored throughout treatment and followed for safety and effectiveness until the study ends.

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC