personalized tumor neoantigen mrna therapy adjuvant treatment for postoperative pancreatic cancer.

Conditions: Pancreatic Cancer Resectable

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 criteria:
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.