Actively Recruiting
Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer
Led by Yanhong Deng · Updated on 2026-03-05
528
Participants Needed
1
Research Sites
456 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of adenocarcinoma of the colon or rectum
- Stage IV metastatic colorectal cancer
- Progression during or within 12 months after completion of adjuvant oxaliplatin treatment, if previously treated
- Withdrawal from standard treatment due to unacceptable toxicity, preventing retreatment with the same agent before disease progression
- Measurable or non-measurable metastatic disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver, and kidney function as required by the protocol
You will not qualify if you...
- Previous or concurrent cancers different from colon cancer within 5 years before randomization
- Significant cardiovascular disease, including unstable angina or myocardial infarction within 6 months before starting treatment
- Heart failure classified as NYHA grade III or IV
- Unresolved toxicity above CTCAE v4.0 Grade 1 from prior therapies or procedures
- Known allergy to study drugs or their components
- Current or recent (within 4 weeks) treatment with another investigational drug or participation in another clinical trial
- Pregnancy or breastfeeding
- Lack of effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanhong Deng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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