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

NCT05540951 | Unknown Phase 3

• 1 other identifier: VICBEV
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

VIC

EXPERIMENTAL

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

Drug: VIC

BEV

ACTIVE COMPARATOR

Bevacizumab Plus Chemotherapy

Drug: Bevacizumab Plus Chemotherapy

Interventions

VIC DRUG

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

VIC

Bevacizumab Plus Chemotherapy DRUG

Bevacizumab Plus Doublet or Triplet Chemotherapy

BEV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Central Study Contacts

Jianmin Xu, MD

CONTACT

86-21-6404-1990; xujmin@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the department of general surgery

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: June 1, 2018
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

CN (1)