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

Fudan University100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Metastatic Colorectal Cancer BRAF V600 Mutation

Interventions

Non interventional studyOTHER

Non interventional study

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

the length of time between initiation of any line treatment for mCRC and the first documented disease progression

Time frame: 6 months

Secondary Outcomes

Overall Survival (OS)

length of time between any treatment initiation (for mCRC) and death (due to any cause)

Time frame: 24 months

Overall Response rate (ORR)

number of complete response (CR) or partial response (PR)