CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 th...
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.
Tracking Information
- NCT #
- NCT03206151
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yuankai Shi Professor, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences Principal Investigator: Yi Ba Professor, Ph.D Tianjin Medical University Cancer Institute & Hospital
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