CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT03206151
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CMAB009 — DRUG
    for injection only
  • Irinotecan — DRUG
    for injection only
  • Folinic acid — DRUG
    for injection only
  • 5-fluorouracil — DRUG
    for injection only

Study Details

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line treatment）may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.

Key Dates

Start date
Dec 12, 2017
Status verified
May 2025
Primary completion
May 6, 2022
Completion
May 6, 2022

Study Design

Enrollment
520 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CMAB009 + FOLFIRI
    Drug: CMAB009(recombinant chimeric anti-EGFR monoclonal antibody injection), will be administered every 7 days at an initial dose of 400mg/m\^2 and 250mg/m\^2 for subsequent infusions until progression of disease , withdrawal of consent, or unacceptable toxicity. Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m\^2 on Day 1. Drug: Folinic Acid infusion 400mg/m\^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-48 h continuous infusion of 2400mg/m\^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.
  • Active Comparator: FOLFIRI
    FOLFIRI Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m\^2 on Day 1. Drug: Folinic Acid infusion 400mg/m\^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-48 h continuous infusion of 2400mg/m\^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year. ]

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