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A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer

NCT07080021 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2025-07-29

No results posted yet for this study

Summary

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

  • Borderline Resectable Pancreatic Adenocarcinoma
  • Resectable Pancreatic Adenocarcinoma

Interventions

DRUG

Standard Reagents, Pancreatic Cancer

This is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2026-05-20
Completion
2027-11-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080021 on ClinicalTrials.gov