VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

September 14, 2022 updated by: Xu jianmin, Fudan University

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Department of General Surgery, Zhongshan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIC
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Drug: VIC
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Active Comparator: BEV
Bevacizumab Plus Chemotherapy
Drug: Bevacizumab Plus Chemotherapy
Bevacizumab Plus Doublet or Triplet Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 3 years
time from first study treatment to the first documented progression disease or death, whichever occurred first
3 years
overall survival
Time Frame: 3 years
time from first study treatment to death from any cause.
3 years
objective response rate
Time Frame: 6 months
the proportion of patients with complete response or partial response.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICBEV

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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