NCT04233151

QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	QL1203	6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
DRUG	Placebo	6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
DRUG	mFOLFOX6 regimen	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.

Timeline

• Start date: 2020-01-20
• Primary completion: 2024-12-31
• Completion: 2025-07-30
• First posted: 2020-01-18
• Last updated: 2023-05-26

Locations

2 sites across 1 country: China