Actively Recruiting
A Prospective Observational Study on Dynamic ctDNA MRD Monitoring in Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
Led by Ruijin Hospital · Updated on 2025-07-29
119
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 meeting NCCN criteria for high-risk resectable, borderline resectable, or locally advanced disease
- Confirmed suitable for neoadjuvant therapy by a multidisciplinary team
- ECOG performance status of 1 or less
- Estimated survival of at least 6 months
- No severe heart, liver, or kidney dysfunction (ALT/AST ≤3× upper limit of normal; creatinine ≤1.5× upper limit of normal)
- Signed written informed consent voluntarily provided
You will not qualify if you...
- Presence of distant metastatic lesions confirmed by imaging
- Any prior anti-tumor therapy including chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- Diagnosis of other active malignancies
- Pregnancy or breastfeeding
- Known 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 or active hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 4 to 8 cycles of neoadjuvant therapy (variable per participant)
Participants undergo standard neoadjuvant therapy for pancreatic cancer as determined by their physicians. Serial blood samples are collected during therapy to monitor Minimal Residual Disease (MRD) using ctDNA technology.
Blood sampling at baseline, end of Cycles 2, 3, 4, and 6
Duration - Single timepoint around surgery
Participants proceed to surgical resection after neoadjuvant therapy. Tissue sampling is performed once by biopsy or surgery, paired with blood sampling before surgery.
1 visit pre-surgery (in-person)
Duration - 1 month post-surgery
Participants are monitored with blood samples collected one month after surgery to assess MRD status and correlate with outcomes.
1 visit at 1 month post-surgery (in-person)
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
F
Fanlu Li, MD
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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