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

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05540951
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 55
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: VIC; Drug: Bevacizumab Plus Chemotherapy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. progression-free survival [3 years]

   time from first study treatment to the first documented progression disease or death, whichever occurred first

2. overall survival [3 years]

   time from first study treatment to death from any cause.

3. objective response rate [6 months]

   the proportion of patients with complete response or partial response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai		China

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xu jianmin, Deputy director of the department of general surgery, Fudan University
• ClinicalTrials.gov Identifier: NCT05540951
• Other Study ID Numbers: VICBEV
• First Posted: Sep 15, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• 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
• Additional relevant MeSH terms: Colorectal Neoplasms; Bevacizumab

Study Results

No Results Posted as of Sep 15, 2022