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NCT Number: NCT06749015

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer BRAF V600 Mutation Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Zhiyu Chen, MD,PhD

CONTACT

[email protected]

64175590

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

Non interventional study

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 6 months

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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 24 months

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

  2. Overall Response rate (ORR)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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