drugset
drugset / Trial / NCT06616259

First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study

NCT06616259 ↗

Phase 3 Not yet recruiting 452 enrolled Meng Qiu
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS/BRAF wild-type, MSS, Unresectable Left-Sided mCRC.

Timeline

Start
2024-09-26
Primary completion
2028-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

colorectal cancer