Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.

Launched by ZHEJIANG UNIVERSITY · Mar 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new personalized treatment for patients with pancreatic cancer that can be surgically removed (resectable). The study will test a special therapy using messenger RNA (mRNA) designed to help the immune system recognize and fight cancer cells, combined with a standard chemotherapy and an antibody treatment. The goal is to see if this new treatment is safe and effective for patients who have just undergone surgery for their cancer.

To join the trial, participants must be at least 18 years old, have a confirmed diagnosis of pancreatic cancer, and have had surgery to remove the tumor. They should also be in good health overall, with normal function of their major organs. Participants will be closely monitored throughout the study, and they will need to agree to use contraception if they are able to have children. This trial is not yet open for recruitment, but it aims to provide valuable insights into a promising new treatment option for pancreatic cancer patients.

Gender

ALL

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.