individualized anti-tumor new antigen iNeo-Vac-R01 injectionGemcitabine + CapecitabineSintilimab injection
individualized anti-tumor new antigen iNeo-Vac-R01 injection: The 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: Gemcitabine: 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: Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. 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.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
* 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;
* 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:
1. Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent);
2. Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);
3. History of primary immunodeficiency;
4. Exceptions: Type 1 diabetes, autoimmune hypothyroidism managed with hormone replacement, vitiligo, or psoriasis not requiring systemic therapy;
* Active bacterial/fungal infections requiring systemic treatment, or active/latent tuberculosis (confirmed by interferon-gamma release assay or tuberculin skin test);
* Active viral infections:
1. HIV antibody-positive;
2. Syphilis (TP antibody-positive with RPR/TRUST confirmation);
3. Active hepatitis C (HCV RNA-positive);
4. Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU/mL);
* Acute viral infections:
1. Herpesvirus infection (unless resolved with crusting \>4 weeks prior);
2. Respiratory viral infection (unless resolved \>4 weeks prior);
* Uncontrolled comorbidities:
1. Symptomatic congestive heart failure (NYHA Class III/IV);
2. Unstable angina or arrhythmia requiring treatment;
3. Severe coronary/cerebrovascular disease (e.g., myocardial infarction within 6 months);
4. 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;
* Pregnancy or lactation;
* Other conditions judged by the investigator to preclude safe participation.
Primary outcome measure(s)
Occurence and frequence of AE and SAE — Up to 2 years Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Zhejiang University Schlool of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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