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CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer

NCT03206151 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-05-23

No results posted yet for this study

Summary

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line treatment）may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.

Conditions

Interventions

DRUG

CMAB009

for injection only

DRUG

Irinotecan

for injection only

DRUG

Folinic acid

for injection only

DRUG

5-fluorouracil

for injection only

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi Professor, Ph.D · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Yi Ba Professor, Ph.D · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2022-05-06
Completion
2022-05-06

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206151 on ClinicalTrials.gov