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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
590
6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m\^2 on Days 1 and 5-fluorouracil 400 mg/m\^2 IV bolus on day 1, then 1200 mg/m\^2/dx2days(total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free Survival(PFS)
Progression-free survival (PFS), assessed by blinded independent central review committee, is defined as the time from randomization to disease progression per RECIST v1.1 criteria or death.
Time frame: From randomization until disease progression up to 12 months
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