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RECRUITING
NCT07085169
PHASE2

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-01

Completion Date

2028-08-01

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

DRUG

Trifluridine/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.

Locations (2)

SanMing First Hospital

Sanming, China

Ruijin Hospital

Shanghai, China