NCT06856187

Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.

Detailed description

This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer. In this study, 119 metastatic colorectal cancer patients who reach CR/PR/SD after 3 months second-line treatment will be randomized to receive sequential TAS-102 +bevacizumab combined with local treatment or continuous treatment of previous second-line therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, PFS, OS, safety and patient reported outcomes.

Conditions

• Metastatic Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	TAS-102+bevacizumab+local treatment	patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment
DRUG	Standard chemotherapy	Standard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-06-30
• Completion: 2027-04-30
• First posted: 2025-03-04
• Last updated: 2025-08-06

Locations

1 site across 1 country: China