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

Locations

1
First Affiliated Hospital of Zhejiang University Schlool of Medicine HangzhouZhejiang, China

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator