NCT04247984

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

An Efficacy and Safety Study of mXELIRI Versus. FOLFIRI + Bevacizumab Therapy as First-line Chemotherapy in Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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 in not previously treated patients with metastatic colorectal cancer (mCRC). In experimental group, untreated patients with metastatic colorectal cancer will receive Irinotecan 150 mg/m2 (D1, q2w) , Xeloda 2000mg/m2 (D1-10, q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment. While in control group, patients with metastatic colorectal cancer will receive Irinotecan 180 mg/m2 (D1, q2w) , CF 300mg/m2 (D1 q2w), 5FU 400mg/m2, D1 2400 mg/m2, civgtt 44h (q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment.The primary endpoint is progression-free survival. Overall survival, Objective Response rate, adverse event and life quality will be assessed as secondary outcomes.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	5 mg/kg intravenously administered on day 1 of a 2-week cycle.
DRUG	Capecitabine	2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
DRUG	Irinotecan	180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
DRUG	5-FU	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	Irinotecan	150 mg/m2 intravenously administered on day 1 of a 2-week cycle.

Timeline

• Start date: 2018-05-01
• Primary completion: 2021-04-01
• Completion: 2022-01-31
• First posted: 2020-01-30
• Last updated: 2022-03-11

Locations

1 site across 1 country: China