Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04230187
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-06-21
First Post:
2020-01-13
Brief Title:
Bevacizumab Plus MFOLFOXIRI As First-line Treatment for Patients with Unresectable Metastatic Colorectal Cancer
Sponsor:
Yanhong Deng
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Bevacizumab Plus MFOLFOXIRI or MFOLFOX-6 As First-line Treatment for Patients with Unresectable Metastatic Colorectal Cancer a Randomised Open-label Phase 3 Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIBE-C
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None