Status:
NOT_YET_RECRUITING
Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Hangzhou Neoantigen Therapeutics Co., Ltd.
Conditions:
Pancreatic Cancer Resectable
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 stand...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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:
- Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent);
- Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);
- History of primary immunodeficiency;
- 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:
- HIV antibody-positive;
- Syphilis (TP antibody-positive with RPR/TRUST confirmation);
- Active hepatitis C (HCV RNA-positive);
- Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU/mL);
- Acute viral infections:
- Herpesvirus infection (unless resolved with crusting \>4 weeks prior);
- Respiratory viral infection (unless resolved \>4 weeks prior);
- Uncontrolled comorbidities:
- Symptomatic congestive heart failure (NYHA Class III/IV);
- Unstable angina or arrhythmia requiring treatment;
- Severe coronary/cerebrovascular disease (e.g., myocardial infarction within 6 months);
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06888674
Start Date
April 1 2025
End Date
April 1 2029
Last Update
March 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China