A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Recruiting

• Conditions: Metastatic Colorectal Cancer; BRAF V600 Mutation

• Registration Number: NCT06749015
• Lead Sponsor: Fudan University

Brief Summary

Previous studies have shown that BRAFV600E mutant mCRC patients have a shorter survival time than BRAF wild type mCRC patients. For Chinese patients, however, it remains unclear about the BRAF gene mutation rate, diagnosis, prognosis and survival data in people with BRAFV600E mutant mCRC .

This real-world, multicenter non-interventional study (NIS) will describe the mutation rate, treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in China.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
• Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay

Exclusion Criteria

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	6 months	the length of time between initiation of any line treatment for mCRC and the first documented disease progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	24 months	length of time between any treatment initiation (for mCRC) and death (due to any cause)
Overall Response rate (ORR)	6 months	number of complete response (CR) or partial response (PR)

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China