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.
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;
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);
Parallel
individualized anti-tumor new antigen iNeo-Vac-R01 injection
Biological/VaccineThe individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.
Gemcitabine + Capecitabine
DrugGemcitabine: 1000 mg/m², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from Day 1 to Day 14. Treatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions.
Sintilimab injection
DrugSintilimab Injection, 200mg, intravenous infusion, every 3 weeks
Occurence and frequence of AE and SAE
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Recurrence-Free Survival (RFS)
Defined as the time from the date of surgery to the first occurrence of disease recurrence or death from any cause (whichever occurs first). Tumor recurrence is defined as the development of one or more new lesions, which may be local (at the primary site), regional (in adjacent lymph nodes or tissues), or distant (metastatic lesions remote from the original resection site).
Recurrence-Free Survival Rate (RFS%)
The proportion of patients free from disease recurrence or death (whichever occurs first) at 12 months, 24 months, and 36 months following surgery.
Overall Survival (OS)
Defined as the time from the date of surgery to death from any cause.
Overall Survival Rate (OS%)
The proportion of patients surviving at 12 months, 24 months, and 36 months following surgery.
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Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator
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