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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540951
• Other study ID #: VICBEV
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2022
• Source: Fudan University
• Contact: Jianmin Xu, MD
• Phone: 86-21-6404-1990
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• VIC
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
• Bevacizumab Plus Chemotherapy
Bevacizumab Plus Doublet or Triplet Chemotherapy

Locations

Country	Name	City	State
China	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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