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

NCT07080021 | Recruiting DMC

• 1 other identifier: KY01003 v2.0 /20200603
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival \[DFS\] / Overall Survival \[OS\])?
2. 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.
3. 3.Receive standard-of-care neoadjuvant therapy/surgery per physician's decision.
4. 4.Undo serial blood draws for ctDNA-MRD testing at predefined timepoints.

Conditions

Borderline Resectable Pancreatic Adenocarcinoma; Resectable Pancreatic Adenocarcinoma

Outcome Measures

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).

  1 years

Secondary Outcomes (1)

• The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).

  2 years

Interventions

Standard Reagents, Pancreatic Cancer DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Subjects meeting ALL of the following criteria will be enrolled:
• Age and Gender :Aged 18-75 years, regardless of gender.
• Diagnosis and Disease Stage :
• Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:
• A. High-risk resectable (meeting ≥1 criterion):
• 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);
• Confirmed regional lymph node metastasis;
• Significant weight loss (\>10% baseline) or severe pain requiring opioids.
• B. Borderline resectable :
• Tumor involving the common hepatic artery without celiac axis contact;
• Tumor contact with SMA ≤180°.
• C. Locally advanced (unresectable):
• Tumor encasement (\>180°) of the SMA, celiac axis, or common hepatic artery;

You may not qualify if:

• Subjects meeting ANY of the following criteria will be excluded:
• Distant Metastasis Radiographically confirmed distant metastatic lesions.
• Prior Anti-Tumor Therapy History of any prior anti-tumor treatment, including:
• Systemic chemotherapy Radiotherapy Interventional therapy Immunotherapy Targeted therapy Anti-tumor traditional Chinese medicine therapy.
• 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 .
• Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .
• Immunodeficiency Disorders Congenital or acquired immunodeficiency, including:
• Human Immunodeficiency Virus (HIV) infection;
• Active Hepatitis B :
• HBsAg-positive andHBV-DNA ≥10,000 copies/mL (≥2,000 IU/mL) at screening;
• Active Hepatitis C :
• HCV-Ab-positive andHCV-RNA positive at screening; Co-infection with HBV and HC

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (2)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Ruijin hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimen Type: FFPE of tumor tissue from biopsy . Whole blood samples (collected longitudinally at defined timepoints during neoadjuvant therapy and follow-up). Collection Purpose: NGS testing for circulating tumor DNA (ctDNA) analysis to assess Minimal Residual Disease (MRD) status. Collection Timeline: Before/during/after neoadjuvant therapy cycles and postoperative.

Central Study Contacts

Baiyong Shen, MD

CONTACT

+86 021-64370045-678805; lfl12522@rjh.com

Fanlu Li, MD

CONTACT

+86 021-64370045-678805; lfl12522@rjh.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): November 20, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-05

Locations

CN (2)