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Recruiting NCT06749015

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

— Observational Metastatic Colorectal Cancer BRAF V600 Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non interventional study.
Who it may be relevant to
Registry conditions: Metastatic Colorectal Cancer, BRAF V600 Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Retrospective, Observational Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Overview

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.

Interventions

  • Other Non interventional study
    Non interventional study

Primary outcome measures

  • Progression-free Survival (PFS) [Time frame: 6 months]
Secondary outcome measures (2)
  • Overall Survival (OS) [Time frame: 24 months]
  • Overall Response rate (ORR) [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06749015 · BRAFm-mCRC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗