Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
The current clinical trials and data on the triplet regimen combined with bevacizumab for
first-line treatment of metastatic colorectal cancer were from European and American
populations. The triplet regimens recommended by the NCCN and ESMO guidelines using
irinotecan and 5-FU at a higher dose intensity cause a high incidence of adverse events in
Asian population, and there was no high-quality data on efficacy in Chinese population, both
of which have limited the clinical applications of the regimens in China. This study intends
to conduct an improved triplet regimen (mFOLFOXIRI) combined with bevacizumab versus mFOLFOX6
combined with bevacizumab as a first-line multicenter, randomized, controlled phase III
clinical trial in patients with advanced colorectal cancer. Progression-free survival (PFS),
observable response rate (ORR), overall survival (OS), disease control rate (DCR), surgical
resection rate, and safety and health-related quality of life (HRQoL) were assessed in the
two groups of subjects.