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

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: Colorectal Cancer
• Intervention / Treatment: Drug: VIC; Drug: Bevacizumab Plus Chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianmin Xu, MD; Phone Number: 3449 86-21-6404-1990; Email: xujmin@aliyun.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Department of General Surgery, Zhongshan Hospital, Fudan University
    • Contact: Jianmin Xu, MD; Phone Number: 3449 86-21-6404-1990; Email: xujmin@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• 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