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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: VIC; Drug: Bevacizumab Plus Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05540951

VICBEV

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

78 participants in 2 patient groups

VIC

Experimental group

Description:

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

Treatment:

Drug: VIC

BEV

Active Comparator group

Description:

Bevacizumab Plus Chemotherapy

Treatment:

Drug: Bevacizumab Plus Chemotherapy