Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.

Korábbi kezelés

• Concurrent immunosuppressive therapy, defined as regular use of immunosuppressive agents within 4 weeks prior to screening or during the study, including but not limited to:
  • Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent);
  • Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);
  • History of primary immunodeficiency;
  • Exceptions: Type 1 diabetes, autoimmune hypothyroidism managed with hormone replacement, vitiligo, or psoriasis not requiring systemic therapy;
• Acute viral infections:
  • Herpesvirus infection (unless resolved with crusting \>4 weeks prior);
  • Respiratory viral infection (unless resolved \>4 weeks prior);

Más betegség

• History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
• Active bacterial/fungal infections requiring systemic treatment, or active/latent tuberculosis (confirmed by interferon-gamma release assay or tuberculin skin test);
• Active viral infections:
  • HIV antibody-positive;
  • Syphilis (TP antibody-positive with RPR/TRUST confirmation);
  • Active hepatitis C (HCV RNA-positive);
  • Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU/mL);
• Uncontrolled comorbidities:
  • Symptomatic congestive heart failure (NYHA Class III/IV);
  • Unstable angina or arrhythmia requiring treatment;
  • Severe coronary/cerebrovascular disease (e.g., myocardial infarction within 6 months);
  • Other conditions deemed exclusionary by the investigator;
• History of drug abuse, psychiatric disorders, or psychosocial factors impairing informed consent or protocol compliance;
• History of severe hypersensitivity to vaccines, biologics, or any component of the study drug;
• Other conditions judged by the investigator to preclude safe participation.

Laborértékek

• Serum CA 19-9 level \>180 U/mL within 21 days prior to initiating standard postoperative adjuvant therapy;

Egyéb

• Subjects meeting any of the following criteria will be excluded from the study:
• Pregnancy or lactation;

• Pre-Screening Phase Inclusion Criteria (for Radical Surgery and Vaccine Preparation):
  • Subjects meeting all of the following criteria will enter the pre-screening phase for radical surgery and vaccine preparation:
  • Voluntarily sign the informed consent form (ICF);
  • Age ≥18 years, regardless of gender;
  • Diagnosed with resectable pancreatic cancer as assessed per the 2024 NCCN Clinical Practice Guidelines and willing to undergo radical surgery;
  • ECOG Performance Status score of 0 or 1;
  • Ability to obtain sufficient fresh tumor tissue samples for whole-exome sequencing (WES) and transcriptome sequencing analysis;
  • Normal function of major organs (heart, liver, kidneys):
  • Liver function: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN;
  • Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
  • Cardiac function: LVEF ≥50% by echocardiography;
  • Contraception agreement: Fertile males and females of childbearing potential must agree to use effective contraception from signing the ICF until 6 months after the last dose of study treatment. Females of childbearing potential include premenopausal women and women ≤2 years postmenopausal;
  • Ability to comply with the study protocol and follow-up procedures.
• Formal Screening Phase Inclusion Criteria (for Study Treatment Initiation):
  • Subjects meeting all of the following criteria will enter the formal screening phase for study treatment:
  • Voluntarily sign the informed consent form (ICF);
  • Age ≥18 years, regardless of gender;
  • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) post-surgery;
  • Completion of radical resection (R0 or R1) with no evidence of metastatic disease, malignant ascites, or pleural effusion on imaging 4-12 weeks postoperatively;
  • ECOG Performance Status score:Cohort A: 0 or 1;Cohort B: 0-2;
  • Normal function of major organs (heart, liver, kidneys):
  • Contraception agreement: Same as pre-screening criteria;
  • Ability to comply with the study protocol and follow-up procedures.