RecruitingNCT07080021

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

A Prospective Observational Cohort Study on Longitudinal Monitoring of ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer


Sponsor

Ruijin Hospital

Enrollment

119 participants

Start Date

May 20, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood test that detects tiny fragments of tumor DNA (called ctDNA or liquid biopsy) to track how well treatment is working in patients with pancreatic cancer who are receiving pre-surgery chemotherapy (called neoadjuvant therapy). It aims to see if this blood test can help predict outcomes and guide treatment decisions. **You may be eligible if...** - You are between 18 and 75 years old with biopsy-confirmed pancreatic cancer - Your cancer is classified as high-risk resectable, borderline resectable, or locally advanced (no distant spread) - Your overall health is good (ECOG score of 0–1) and your organs are functioning adequately - You have not previously received any cancer treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have received prior cancer treatment (chemotherapy, radiation, surgery, immunotherapy, etc.) - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C, or have had an organ or stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard 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.


Locations(2)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Ruijin hospital

Shanghai, China

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NCT07080021


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