drugset / Trial / NCT05948072

Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM

NCT05948072

Phase 3 Unknown 250 enrolled Fudan University
RandomizedParallel-groupSingle-blindTreatment

Summary

For patients with initially resectable colorectal cancer liver metastases who have high-risk factors, neoadjuvant therapy is currently considered a consensus approach. However, there is ongoing debate regarding the optimal treatment strategy. Our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone. The objective of this phase III clinical trial is to determine whether the combination of cetuximab and mFOLFOX6 chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type RAS/BRAF and high-risk factors.

Timeline

Start
2023-07-15
Primary completion
2026-07-15
Completion
2026-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Background Leucovorin Small molecule 350 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous