RecruitingPhase 1Phase 2NCT07012954

ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC

ctDNA-Guided Rechallenge With Cetuximab Plus Trifluridine/Tipiracil Versus Bevacizumab Plus Trifluridine/Tipiracil for RAS/BRAF Wild-Type Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

64 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this randomized controlled clinical trial is to evaluate the efficacy of ctDNA-guided rechallenge with cetuximab plus trifluridine/tipiracil compared with bevacizumab plus trifluridine/tipiracil in patients with treatment-refractory, RAS/BRAF wild-type metastatic colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is using circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA found in the blood — to guide the choice between two targeted drug combinations as later-line treatment for metastatic colorectal cancer that started as RAS/BRAF wild-type (without those specific mutations). **You may be eligible if...** - You have metastatic colorectal cancer with confirmed RAS/BRAF wild-type status - You previously had at least 6 months of benefit from a cetuximab-based first-line regimen, then progressed - You have already received at least one further line of treatment after that progression **You may NOT be eligible if...** - Your colorectal cancer has developed RAS mutations detected in blood tests (ctDNA) - Your overall health is significantly compromised - You have had prior treatment with trifluridine/tipiracil (TAS-102) - You are pregnant or breastfeeding 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

DRUGCetuximab (Erbitux, C225)

cetuximab 500 mg/m² repeated every two weeks.

DRUGtrifluridine/tipiracil

Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off)

DRUGBevacizumab ( Avastin)

bevacizumab 5 mg/kg


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07012954


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