A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT04247984
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    5 mg/kg intravenously administered on day 1 of a 2-week cycle.
  • Capecitabine — DRUG
    2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
  • Irinotecan — DRUG
    180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
  • 5-FU — DRUG
    400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.
  • CF — DRUG
    300 mg/m2 intravenously administered on day 1 of a 2-week cycle.
  • Irinotecan — DRUG
    150 mg/m2 intravenously administered on day 1 of a 2-week cycle.

Study Details

This is a Phase II, multicenter，randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).

Key Dates

Start date
May 1, 2018
Status verified
Mar 2022
Primary completion
Apr 1, 2021
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: mXELIRI+ Bevacizumab
  • Active Comparator: FOLFIRI + Bevacizumab

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 6 Months ]

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