NCT06293014

TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer

A Randomized, Open-label, Multicentre Clinical Study of TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.

Detailed description

This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, DoR, PFS, OS, safety and patient reported outcomes. This study plans to enroll 224 patients with advanced colorectal cancer who have previously achieved disease control after second-line induction therapy with standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab. The subjects will be randomly assigned in a 1:1 ratio to the TAS-102 combined with bevacizumab second-line maintenance treatment group (experimental group) and the standard chemotherapy combined with bevacizumab second-line continuous treatment group (control group).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TAS-102+bevacizumab	TAS-102 35mg/m2, PO, D1-5, repeated every 14 days; Bevacizumab 5mg/kg, IV, D1, repeated every 14 days; Q4w.
DRUG	Standard chemotherapy+bevacizumab	Standard chemotherapy (chemotherapy regimen based on investigator's choice, including FOLFIRI, FOLFOX, or CAPEOX); Bevacizumab

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-10-15
• Completion: 2026-11-28
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: China