Patients with advanced pancreatic adenocarcinoma
Conditions
Interventions
Treatment group A:Neoantigen personalized mRNA cancer vaccine
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily signed the informed consent form and complied with protocols requirements; 2) Patients with histologically or cytologically confirmed advanced ductal pancreatic adenocarcinoma who have failed or are intolerant to =2 line standard therapy; 3) ECOG Performance Status of 0 or 1; 4) Life expectancy = 12 weeks; 5) At least one measurable disease per RECIST v1.1; 6) Sufficient amounts of fresh tumor tissue can be obtained through biopsy or surgery before treatment, or sufficient amounts of paraffin tissue sections within 1 year can be obtained; 7) Adequate marrow and organ function; 8) Have resolution of toxic effects from prior therapy to Grade 1 or less per CTCAE v5.0; 9) Patients with fertility are willing to use an adequate method of contraception.
Exclusion criteria
Exclusion criteria: 1) Prior malignancy within 5 years prior to study entry; 2) Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled); 3) Prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 28 days prior to initiation of study treatment; 4) Have previously received cell therapy or other tumour therapeutic vaccines; 5) Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines; 6) Uncontrolled pleural effusion, pericardial effusion, or ascites within 14 days prior to initiation of study treatment; 7) Currently taking a daily dose of =10mg Systemic steroid therapy or other form of immunosuppressive therapy prior to initiation of study treatment; 8) Active or history of autoimmune disease; 9) Active tuberculosis or infection requiring treatment; 10) HIV positive, HCV positive, HBV DNA copies =500 IU/ml; 11) Significant cardiovascular disease; 12) Other situations that are not suitable for inclusion in this study judged by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who meet the criteria of DLT in cycle 1 [Time Frame: Day 1 to Day 21 after the first cancer vaccine was administrated];Percentage of subjects with Adverse Events (AEs) [Time Frame: From baseline up to end of the study (up to approximately 16 months)]; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactRong Liu
Chinese PLA General Hospital
Outcome results
None listed