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Trial Title:
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
NCT ID:
NCT05540951
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
VIC
Description:
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Arm group label:
VIC
Intervention type:
Drug
Intervention name:
Bevacizumab Plus Chemotherapy
Description:
Bevacizumab Plus Doublet or Triplet Chemotherapy
Arm group label:
BEV
Summary:
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in
Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal
was to evaluate the safety of VIC regimen, and to investigate the tumor response, the
radical resectability, and the patient survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 and ≤80 years old
- Histologically confirmed colorectal adenocarcinoma
- Histologically confirmed BRAFV600E mutated and RAS wild-type
- Initially unresectable metastatic or local CRC
- ECOG performance status of 0-1 and life expectancy ≥3 months
- adequate hepatic, renal, and hematologic function
Exclusion Criteria:
- Previously taken any targeted therapy, chemotherapy, intervention therapy, or
radiotherapy for CRC within 6 months
- Other cancers (with the exception of cervical cancer in situ and squamous cell
carcinoma of the skin) within the previous 5 years.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of General Surgery, Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianmin Xu, MD
Phone:
86-21-6404-1990
Phone ext:
3449
Email:
xujmin@aliyun.com
Start date:
June 1, 2018
Completion date:
December 30, 2022
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05540951
