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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 15, 2023

Primary Completion Date

July 15, 2026

Study Completion Date

July 15, 2026

Conditions
Colorectal CancerLiver Metastases
Interventions
DRUG

mFOLFOX6 + Cetuximab

Cetuximab + mFOLFOX6: Cetuximab (500mg/m2 IV ) will be given. Oxaliplatin (85 mg/m2 IV over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV over 2 h on day 1) plus a bolus of 5FU (400 mg/m2) followed by a 46h-48h IV infusion of 5FU 2400 mg/m2 will be repeated for every 2 weeks. The regimens repeat every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

DRUG

mFOLFOX 6

mFOLFOX6: Oxaliplatin (85 mg/m2 IV over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV over 2 h on day 1) plus a bolus of 5FU (400 mg/m2) followed by a 46h-48h IV infusion of 5FU 2400 mg/m2 will be repeated for every 2 weeks. The regimens repeat every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Trial Locations (1)

200032

Zhongshan hosptial, Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER

NCT05948072 - Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM | Biotech Hunter | Biotech Hunter