Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer receiving radiotherapy plus SOC with or without PD-1.
This study will enroll patients with histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. The study will employ ctDNA methylation detection technology to quantitatively assess ctDNA methylation levels in patient plasma samples. Blood samples will be collected at baseline and at multiple predefined timepoints during treatment. In addition, participants will undergo standard imaging surveillance (CT/MRI) every three months. The study aims to correlate ctDNA dynamics with therapeutic response, time to recurrence, and survival outcomes. Ultimately, it seeks to evaluate the potential of ctDNA monitoring for predicting treatment efficacy and prognosis, and to explore its utility in guiding clinical management for metastatic colorectal cancer.
Study Type
OBSERVATIONAL
Enrollment
497
Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGPFS
To investigate ctDNA-based disease-free survival (ctDNA-DFS), CT-based disease-free survival (CT-DFS), and the difference between ctDNA-DFS and CT-DFS (△-DFS).
Time frame: up to 2 years
OS
To exam whether 3- and 5-year overall survival (OS) with ctDNA-guided surveillance is comparable to that achieved with standard CT-based monitoring.
Time frame: up to 5 year
Patient-reported outcomes (quality of life)
To assess patient-reported outcomes-quality of life (EORTC QLQ-C30)-in those receiving ctDNA-guided versus standard surveillance.
Time frame: up to 5 year
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