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

NCT04233151 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2023-05-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Shen, Professor · Peking University Cancer Hospital & Institute

  • Weijian Guo, Professor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2024-12-31
Completion
2025-07-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233151 on ClinicalTrials.gov