Actively Recruiting
A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
Led by Ruijin Hospital · Updated on 2025-07-29
119
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Pathologically confirmed pancreatic cancer
- Meets NCCN criteria for high-risk resectable, borderline resectable, or locally advanced pancreatic cancer
- Suitable for neoadjuvant therapy as determined by a multidisciplinary team
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy of at least 6 months
- No severe heart, liver, or kidney dysfunction (ALT/AST less than 3 times normal; serum creatinine less than 1.5 times normal)
- Signed written informed consent
You will not qualify if you...
- Presence of distant metastatic lesions
- History of any prior anti-tumor therapy including chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- Diagnosis of other active malignant tumors
- Pregnancy or breastfeeding
- Allergy to any agents in the recommended first-line neoadjuvant regimen
- History of allogeneic hematopoietic stem cell or solid organ transplantation
- Congenital or acquired immunodeficiency including HIV infection
- Active Hepatitis B or C infection with specified viral loads
- Co-infection with both Hepatitis B and C viruses
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
2
Ruijin hospital
Shanghai, China
Actively Recruiting
Research Team
B
Baiyong Shen, MD
CONTACT
F
Fanlu Li, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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