Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

This is an interventional treatment trial for Resectable Pancreatic Cancer Read More

Inclusion Criteria：

1. Must freely sign informed consent;
2. Aged 18 to 70 years old;
3. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
4. Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
5. ECOG score is 0 or 1;
6. Completed an R0 or R1 surgical resection as determined by pathology；
7. Completion of at least 4 months of adjuvant chemotherapy with ticgio monotherapy or mFOLFIRINOX;
8. Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
9. The end of chemotherapy is followed by a one-week natural washout period；

10. Haematological index：

    • White blood cells ≥ 3500 / MCL
    • Lymphocytes > 800/ MCL
    • neutrophils > 1500/ MCL
    • Platelets > 100000 / MCL
    • Hemoglobin >10.0g/dL
    • Total serum bilirubin <1.5× upper limit of normal value (ULN)
    • AST/ALT<2.0 times the upper limit of normal
    • Serum creatinine <1.5 times the upper limit of normal；
11. Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
12. Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

1. Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
2. Diagnosed as other malignant tumor;
3. No neoantigen was found in the sequencing data;
4. There have been bone marrow or stem cell transplants;
5. Received systemic glucocorticoids with immunosuppressants;
6. Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
7. With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
8. Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
9. Infected with herpes virus (except those with scabs of more than 4 weeks)；
10. Infected with respiratory virus (except those who have recovered for more than 4 weeks);
11. Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
12. Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
13. Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.