Spots Global Cancer Trial Database for QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety
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Trial Identification
Brief Title: QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety
Official Title: A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of QL1203 and Placebo Respectively Combined With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT04233151
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.
Detailed 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 Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Cancer Hospital, Beijing, Beijing, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Lin Shen, Professor
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Weijian Guo, Professor
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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