About this trial
This study is a single-center, open-label clinical study to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimen as adjuvant treatment for postoperative resectable pancreatic cancer.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Serum CA 19-9 level >180 U/mL within 21 days prior to initiating standard postoperative adjuvant therapy;
History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent);
Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);
Trial design
Treatments tested in this trial
- individualized anti-tumor new antigen iNeo-Vac-R01 injection
- Gemcitabine + Capecitabine
- Sintilimab injection
Treatment groups
Sponsors and collaborators
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator