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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of 119 patients aged 18-75 years with pathologically confirmed pancreatic cancer meeting NCCN-defined criteria for high-risk resectable, borderline resectable, or locally advanced stage. Eligibility requires multidisciplinary discussion (MDT) confirmation of suitability for neoadjuvant therapy, ECOG performance status ≤1, estimated survival ≥6 months, no severe organ dysfunction, and provision of informed consent. Subjects with distant metastasis, prior anti-tumor therapy, or concurrent malignancies are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard Reagents, Pancreatic Cancer
DrugThis is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
To evaluate the correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
Time frame
1 yearsSecondary outcomes
1
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).
To evaluate the correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov