NCT03206151

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

Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be randomly assign in one of the two groups to either receive the combination chemotherapy alone or with CMAB009 and will then be treated until progression of the disease or unacceptable toxicity occurred. Regular efficacy assessments（every 8 weeks）based on imaging will be performed throughout the study together with regular safety assessments. After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CMAB009	for injection only
DRUG	Irinotecan	for injection only
DRUG	Folinic acid	for injection only
DRUG	5-fluorouracil	for injection only

Timeline

• Start date: 2017-12-12
• Primary completion: 2022-05-06
• Completion: 2022-05-06
• First posted: 2017-07-02
• Last updated: 2025-05-23

Locations

2 sites across 1 country: China