A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 colo...
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.
Tracking Information
- NCT #
- NCT04247984
- Collaborators
- Beijing Hospital
- Henan Cancer Hospital
- Liaoning Tumor Hospital & Institute
- Jiangsu Cancer Institute & Hospital
- Investigators
- Not Provided