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

Research Summary Study Name ：Prospective and Observational Study on MRD Dynamic Monitoring of Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer Study Introduction ：This study investigates borderline resectable pancreatic cancer patients undergoing neoadjuvant therapy followed by surgical resection. It dynamically monitors Minimal Residual Disease (MRD) using circulating tumor DNA (ctDNA) technology to examine the correlation between MRD status at various monitoring points and patients' R0 resection rates, Disease-Free Survival (DFS), and Overall Survival (OS). The hypothesis states that MRD-negative patients have significantly better prognosis than MRD-positive patients. Primary Objective ：To evaluate the correlation between ctDNA-based MRD status at different monitoring points during neoadjuvant therapy and therapeutic efficacy/prognosis (DFS/OS). To explore whether MRD status can help determine the optimal duration of neoadjuvant therapy. Study Subjects Sample size : 119 cases Inclusion criteria : Age 18-75 years Pathologically confirmed pancreatic cancer Meets NCCN criteria for high-risk resectable, borderline resectable, or locally advanced disease MDT discussion confirming suitability for neoadjuvant therapy ECOG score ≤1 Exclusion criteria : Distant metastasis History of anti-tumor therapy Concurrent other malignancies Study Unit/Location ：Department of Pancreatic Surgery, Ruijin Hospital Study Intervention ：This is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards. Study Duration ：24 months (12 months recruitment + 12 months follow-up) Subject Participation Duration ：Each subject requires 18 months to complete the study. Protocol: A total of 119 subjects will be enrolled. Each subject will undergo 4 to 8 cycles of neoadjuvant therapy . Tumor tissue sampling will be performed once either via pre-neoadjuvant biopsy or surgical resection (biopsy-derived tissue is preferred ) and paired with serial peripheral blood sampling (for MRD detection ), as detailed in the accompanying schematic diagram. Peripheral Blood Collection Schedule: 1. Pre-neoadjuvant treatment： End of Cycle 2 End of Cycle 3 End of Cycle 4 End of Cycle 6 2. Pre-surgery； 3.1 month Post-surgery. Sample Volume: 10 ml whole blood collected at each time point during neoadjuvant therapy; 20 ml whole blood collected at baseline (pre-treatment) , pre-surgery , and 1-month post-surgery . Sample Handling: All collected samples will be transferred to the central laboratory for subsequent analysis. Analysis will include: high-throughput sequencing (NGS) for evaluation of Minimal Residual Disease (MRD) status .