Evaluating Safety and Effectiveness of ctDNA-Guided Anti-EGFR Retreatment in Real-World Metastatic Colorectal Cancer Patients

What this Trial Is About

Researchers are studying metastatic colorectal cancer mCRC patients to understand how well anti-EGFR retreatment works when selected based on ctDNA analysis. This observational, retrospective, international, and multicenter study focuses on patients with MSS mCRC who have been screened for RASBRAFPIK3CA mutations using liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The goal is to assess the effectiveness of anti-EGFR rechallenge treatments in a large real-world patient group. The study collects existing clinical and molecular data from participating centers, including patient age, gender, ethnicity, tumor histology, molecular profiles from tissue and liquid biopsies, and treatment histories. It tracks responses to therapies using RECIST v1.1 criteria and evaluates outcomes such as response rate, disease control rate, duration of response, progression-free survival, time-to-treatment failure, and overall survival. Patients included are those screened for ctDNA within the MEN1611-02 clinical trial. Participants data on diagnosis dates, performance status, metastasis sites, and treatments received after ctDNA analysis are collected retrospectively. Researchers review clinical outcomes and survival data up to two years to evaluate the efficacy of anti-EGFR rechallenge. Since this is a retrospective observational study, there is no new treatment or intervention administered, and participants usual care is not affected.

Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort (the REalCHALLENGE Study)