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

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