A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer
NCT04247984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264
Last updated 2022-03-11
Summary
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).
Conditions
Interventions
- BIOLOGICAL
-
5 mg/kg intravenously administered on day 1 of a 2-week cycle.
- DRUG
-
2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
- DRUG
-
180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
- DRUG
-
400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.
- DRUG
-
CF
300 mg/m2 intravenously administered on day 1 of a 2-week cycle.
- DRUG
-
150 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Sponsors & Collaborators
-
Beijing Hospital
collaborator OTHER_GOV -
Henan Cancer Hospital
collaborator OTHER_GOV -
Liaoning Cancer Hospital & Institute
collaborator OTHER -
Jiangsu Cancer Institute & Hospital
collaborator OTHER -
Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-01
- Primary Completion
- 2021-04-01
- Completion
- 2022-01-31
Countries
- China
Study Locations
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