A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age and Gender :Aged 18-75 years, regardless of gender.
Luminal stenosis of the portal vein or superior mesenteric vein on imaging;
Radiographic stage T≥3 or N≥1;
Serum CA19-9 ≥1000 U/mL (after resolution of jaundice);
Disqualifiers
Distant Metastasis Radiographically confirmed distant metastatic lesions.
Concurrent Malignancy Diagnosis of other active malignancies.
Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.
Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .
Trial design
Treatments tested in this trial
- Standard Reagents, Pancreatic Cancer
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov