Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer (TRIBE-C)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    528
  • sponsor
    Yanhong Deng
Updated on 10 July 2022
measurable disease
fluorouracil
irinotecan
metastatic colorectal cancer
bevacizumab
adjuvant therapy
adenocarcinoma
solid tumour
adenocarcinoma of colon
modified folfox6 regimen

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.

Details
Condition Colorectal Cancer
Treatment mFOLFOXIRI plus Bevacizumab, mFOLFOX6 Plus Bevacizumab
Clinical Study IdentifierNCT04230187
SponsorYanhong Deng
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded
Subjects with metastatic colorectal cancer(CRC) (Stage IV). Subjects treated with
oxaliplatin in an adjuvant setting should have progressed during or within 12 months of
completion of adjuvant therapy
Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting
discontinuation of treatment and precluding retreatment with the same agent prior to
progression of disease will also be allowed into the study
Metastatic CRC subjects must have measurable or non measurable disease according to
Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Adequate bone
marrow, liver and renal function as assessed by the laboratory required by protocol

Exclusion Criteria

Previous or concurrent cancer that is distinct in primary site or histology from colon
cancer within 5 years prior to randomization
Significant cardiovascular disease including unstable angina or myocardial infarction
within 6 months before initiating study treatment
Heart failure grade III/IV (NYHA-classification). Unresolved toxicity higher than CTCAE
v.4.0 Grade 1 attributed to any prior therapy/procedure
Subjects with known allergy to the study drugs or to any of its excipients. Current or
recent (within 4 weeks prior to starting study treatment) treatment of another
investigational drug or participation in another investigational study
Breast- feeding or pregnant women Lack of effective contraception
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