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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histologically confirmed colorectal adenocarcinoma

• Initial RAS/BRAF wild-type status

• Received first-line treatment with FOLFOX, FOLFIRI, or FOLFOXIRI combined with cetuximab, with documented clinical benefit (CR/PR/SD) and progression-free survival (PFS) ≥ 6 months

• Disease progression occurred during or within 3 months after cetuximab-based first-line therapy

• Experienced further tumor progression after receiving second-line or subsequent treatments

• At least 4 months have elapsed since the last administration of cetuximab

• At least one measurable lesion according to RECIST v1.1

• RAS/BRAF wild-type status confirmed by blood-based ctDNA testing

• Normal hematologic function (platelets \> 90 × 10⁹/L; white blood cells \> 3 × 10⁹/L; neutrophils \> 1.5 × 10⁹/L; hemoglobin \> 10.0 g/100 ml)

• Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), transaminases ≤ 5 × ULN

• No ascites, normal coagulation function, serum albumin ≥ 35 g/L

• Child-Pugh class A liver function

• Serum creatinine below ULN or calculated creatinine clearance \> 50 ml/min (using the Cockcroft-Gault formula)

• ECOG performance status of 0-1

• Expected survival \> 3 months

• Signed written informed consent

• Willing and able to undergo follow-up until death, study completion, or study termination

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Deshen Wang, PhD
wangdsh@sysucc.org.cn
87342487
Backup
Ruihua Xu, PhD
xurh@sysucc.org.cn
87342479
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 64
Treatments
Experimental: cetuximab plus trifluridine/tipiracil
Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off) plus cetuximab 500 mg/m² intravenous drip (IVD) once every two weeks.
Active_comparator: bevacizumab plus trifluridine/tipiracil
Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off) plus bevacizumab 5 mg/kg administered by intravenous drip (IVD), repeated every two weeks.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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