Condition: Borderline Resectable Pancreatic Adenocarcinoma · Resectable Pancreatic Adenocarcinoma · Sponsor: Ruijin Hospital
The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are: 1. Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival \[DFS\] / Overall Survival \[OS\])? 2. Can serial MRD status assessments guide optimal neoadjuvant therapy duration? Participants (n=119) will be adults aged 18-75 years with histologically confirmed pancreatic cancer meeting NCCN criteria for borderline resectable/high-risk resectable/locally advanced disease, deemed eligible for neoadjuvant therapy by a multidisciplinary team (MDT) and with ECOG performance status ≤1. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded. During 24-month study period (12-month recruitment + 12-month follow-up), enrolled subjects will: 1. Receive standard-of-care neoadjuvant therapy/surgery per physician's decision. 2. Undo serial blood draws for ctDNA-MRD testing at predefined timepoints. 2\. Be followed for DFS/OS outcomes for 18 months. This non-interventional study is conducted at Ruijin Hospital Pancreatic Surgery Department.
This description comes directly from the study's public registry record.
Baiyong Shen, MD · +86 021-64370045-678805 · lfl12522@rjh.com
Fanlu Li, MD · +86 021-64370045-678805 · lfl12522@rjh.com
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| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai, China | Recruiting |
| Ruijin hospital | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07080021