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

NCT ID: NCT05540951

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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VIC

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

Group Type EXPERIMENTAL

VIC

Intervention Type DRUG

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

BEV

Bevacizumab Plus Chemotherapy

Group Type ACTIVE_COMPARATOR

Bevacizumab Plus Chemotherapy

Intervention Type DRUG

Bevacizumab Plus Doublet or Triplet Chemotherapy

Interventions

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VIC

VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)

Intervention Type DRUG

Bevacizumab Plus Chemotherapy

Bevacizumab Plus Doublet or Triplet Chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Deputy director of the department of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianmin Xu, MD

Role: CONTACT

86-21-6404-1990 ext. 3449

Facility Contacts

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Jianmin Xu, MD

Role: primary

86-21-6404-1990 ext. 3449

Other Identifiers

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VICBEV

Identifier Type: -

Identifier Source: org_study_id

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