QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placeb...
The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.
Tracking Information
- NCT #
- NCT04233151
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital Principal Investigator: Weijian Guo, Professor Fudan University