Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

PHASE3CompletedINTERVENTIONAL
Enrollment

688

Participants

Timeline

Start Date

December 31, 2020

Primary Completion Date

March 22, 2023

Study Completion Date

January 26, 2024

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Double blind control period A140

experiment arm: Drug A140:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv), Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h) control arm: Drug Erbitux:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv) Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h)

DRUG

Open single period A140

Drug A140:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv), Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h)

Trial Locations (1)

100071

307 Hospital of PLA, Beijing

All Listed Sponsors
lead

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

INDUSTRY

NCT04835142 - Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC | Biotech Hunter | Biotech Hunter