RecruitingPhase 2NCT06856187

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


Sponsor

Fudan University

Enrollment

119 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment approach for advanced colorectal cancer that has stopped responding to first-line therapy. It combines a standard second-line drug (TAS-102, also called trifluridine/tipiracil) with bevacizumab (a drug that blocks tumor blood vessel growth) and local treatments aimed at specific tumor sites. **You may be eligible if...** - You have unresectable (cannot be surgically removed) colorectal cancer confirmed by biopsy or cytology - Your cancer has progressed on first-line standard therapy and you need second-line treatment - You have at least one measurable tumor on imaging - Your general health score is 0–1 (ECOG) and life expectancy is at least 3 months - Your organ function (blood counts, kidney, liver) meets required levels **You may NOT be eligible if...** - You have previously been treated with TAS-102 - You are pregnant or breastfeeding - You have unresolved side effects (Grade 2 or higher) from prior treatment - You have a bleeding disorder or are on full-dose anticoagulants - You have had a serious cardiovascular event recently 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

DRUGTAS-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

DRUGStandard chemotherapy

Standard therapy:FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06856187


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