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COMPLETED
NCT04835142
PHASE3

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

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks

Official title: Phase III Clinical Study Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

688

Start Date

2020-12-31

Completion Date

2024-01-26

Last Updated

2026-05-08

Healthy Volunteers

No

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)

Locations (1)

307 Hospital of PLA

Beijing, Beijing Municipality, China