Observational Study of ctDNA-Based Minimal Residual Disease Monitoring During Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer

What this Trial Is About

This research aims to understand the usefulness of dynamic monitoring of Minimal Residual Disease MRD using circulating tumor DNA ctDNA in adults with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The study focuses on whether MRD negativity relates to better surgical outcomes, including complete tumor removal R0 resection, and longer disease-free and overall survival. It also explores if repeated MRD assessments can guide the best length of neoadjuvant therapy. Participants will receive standard neoadjuvant therapy and surgery as decided by their doctors, without any experimental treatment assigned by the study. Blood samples will be collected multiple times before, during, and after therapy to test for MRD using ctDNA technology. The study will last 24 months, including 12 months of recruitment and 12 months of follow-up, with each participant involved for 18 months covering therapy cycles and postoperative monitoring. During the study, participants will have tumor tissue sampled once, either by biopsy before starting therapy or during surgery. Blood samples will be taken at specific points before treatment, after certain therapy cycles, before surgery, and one month after surgery. Researchers will analyze these samples in a central lab using high-throughput sequencing to evaluate MRD status. The main measurement is the correlation between MRD status and surgical success, while survival outcomes like disease-free survival and overall survival will also be tracked.

A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer