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

Prior treatment

• 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

• 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:
  • 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.
  • Borderline resectable :
  • Tumor involving the common hepatic artery without celiac axis contact;
  • Tumor contact with SMA ≤180°.
  • Locally advanced (unresectable):
  • Tumor encasement (\>180°) of the SMA, celiac axis, or common hepatic artery;
  • Unreconstructable involvement of SMV/portal vein;
  • No distant metastasis.
  • Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .
  • Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .
  • Life Expectancy :Estimated survival ≥6 months.
  • Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:
  • ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
  • Informed Consent :Signed written informed consent voluntarily provided.