ctDNA MRD monitoring during neoadjuvant treatment for pancreatic cancer

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

We will see if regular blood tests for ctDNA (MRD) during neoadjuvant therapy can predict surgical success and longer survival for adults with borderline resectable or high‑risk resectable pancreatic cancer.

Quick facts

• Study type: Observational
• Enrollment: 119 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Immunotherapy
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT07080021 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of 119 adults (age 18–75) with borderline resectable, high‑risk resectable, or locally advanced pancreatic adenocarcinoma who are planned for neoadjuvant therapy at Ruijin Hospital. Participants will receive standard-of-care neoadjuvant treatment determined by a multidisciplinary team while undergoing serial blood draws to measure ctDNA-based MRD at defined time points. The study will correlate MRD status changes with surgical outcomes (including R0 resection rates) and survival endpoints (DFS and OS) and explore whether MRD dynamics can inform optimal neoadjuvant therapy duration. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded, and follow-up spans the planned recruitment and observation period.

Who should consider this trial

Good fit: Adults 18–75 years with histologically confirmed borderline resectable, high‑risk resectable, or locally advanced pancreatic adenocarcinoma who are candidates for neoadjuvant therapy and have ECOG ≤1 are ideal.

Not a fit: Patients with distant metastases, prior anticancer therapy, concurrent other malignancies, or poor performance status are unlikely to benefit from this monitoring approach in this protocol.

Why it matters

Potential benefit: If successful, this approach could help personalize neoadjuvant treatment timing and identify patients more likely to achieve R0 resection and longer DFS/OS.

How similar studies have performed: ctDNA MRD monitoring has shown prognostic value in several other solid tumors and early pancreatic cancer studies are promising but remain preliminary and not yet definitive.

Eligibility criteria

Inclusion Criteria:

* Subjects meeting ALL of the following criteria will be enrolled:

  1. Age and Gender :Aged 18-75 years, regardless of gender.
  2. Diagnosis and Disease Stage :

     Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:

     A. High-risk resectable (meeting ≥1 criterion):
     1. Luminal stenosis of the portal vein or superior mesenteric vein on imaging;
     2. Radiographic stage T≥3 or N≥1;
     3. Serum CA19-9 ≥1000 U/mL (after resolution of jaundice);
     4. Confirmed regional lymph node metastasis;
     5. Significant weight loss (\>10% baseline) or severe pain requiring opioids.

     B. Borderline resectable :
     1. Tumor involving the common hepatic artery without celiac axis contact;
     2. Tumor contact with SMA ≤180°.

     C. Locally advanced (unresectable):
     1. Tumor encasement (\>180°) of the SMA, celiac axis, or common hepatic artery;
     2. Unreconstructable involvement of SMV/portal vein;
     3. No distant metastasis.
  3. Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .
  4. Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .
  5. Life Expectancy :Estimated survival ≥6 months.
  6. Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:

     ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
  7. Informed Consent :Signed written informed consent voluntarily provided.

Exclusion Criteria:

* Subjects meeting ANY of the following criteria will be excluded:

  1. Distant Metastasis Radiographically confirmed distant metastatic lesions.
  2. 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.
  3. Concurrent Malignancy Diagnosis of other active malignancies.
  4. Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.
  5. Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .
  6. Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .
  7. 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

Where this trial is running

Shanghai and 1 other locations

• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
• Ruijin hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Baiyong Shen, MD

Conditions Borderline Resectable Pancreatic Adenocarcinoma; Resectable Pancreatic Adenocarcinoma