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

Phase 3

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: VIC; Drug: Bevacizumab Plus Chemotherapy

• Registration Number: NCT05540951
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIC	VIC	VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
BEV	Bevacizumab Plus Chemotherapy	Bevacizumab Plus Chemotherapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China