Back to resultsVIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
VIC
Bevacizumab Plus Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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.
Sites / Locations
- Department of General Surgery, Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VIC
BEV
Arm Description
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Bevacizumab Plus Chemotherapy
Outcomes
Primary Outcome Measures
progression-free survival
time from first study treatment to the first documented progression disease or death, whichever occurred first
overall survival
time from first study treatment to death from any cause.
objective response rate
the proportion of patients with complete response or partial response.
Secondary Outcome Measures
Full Information
NCT ID
NCT05540951
First Posted
September 12, 2022
Last Updated
September 14, 2022
Sponsor
Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05540951
Brief Title
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
Official Title
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VIC
Arm Type
Experimental
Arm Description
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Arm Title
BEV
Arm Type
Active Comparator
Arm Description
Bevacizumab Plus Chemotherapy
Intervention Type
Drug
Intervention Name(s)
VIC
Intervention Description
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Plus Chemotherapy
Intervention Description
Bevacizumab Plus Doublet or Triplet Chemotherapy
Primary Outcome Measure Information:
Title
progression-free survival
Description
time from first study treatment to the first documented progression disease or death, whichever occurred first
Time Frame
3 years
Title
overall survival
Description
time from first study treatment to death from any cause.
Time Frame
3 years
Title
objective response rate
Description
the proportion of patients with complete response or partial response.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, MD
Phone
86-21-6404-1990
Ext
3449
Email
xujmin@aliyun.com
Facility Information:
Facility Name
Department of General Surgery, Zhongshan Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, MD
Phone
86-21-6404-1990
Ext
3449
Email
xujmin@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
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