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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator