advanced pancreatic cancer pancreatic cancer, neoantigen, dendritic cell, cancer vaccines
Conditions
Interventions
The patients received chemotherapy (GEM at a dose of 1,000 mg/m2 and nab-PTX at a dose of 125 mg/m2) intravenously on days 1, 8, and 15 of a 28-day cycle.When mFFX is used as standard therapy, it shou
neoantigen/DC vaccine,Gemcitabine,nab-PTX
Sponsors
Koido Shigeo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Human leukocyte antigen (HLA)-A*02:01- or A*24:02-positive patients. Patients with histologically or cytologically confirmed locally advanced or metastatic pancreatic cancer, or recurrent disease after surgery. Patients with ages between 20 and 75 years. Karnofsky performance status (KPS) of 80% to 100%. Patients with a KPS of 70% were also included but only if KPS was decreased by poorly controlled cancerous pain at enrollment. Patients had adequate hematologic, hepatic, and renal function. Patients had a life expectancy of at least 3 months. All patients provided written informed consent.
Exclusion criteria
Exclusion criteria: The exclusion criteria were pregnancy, serious infections, severe underlying disease, severe allergic disease, and a judgment of unsuitability by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the assessment of the safety and toxicity of the combination therapy based on the Common Terminology Criteria for Adverse Events (CTCAE). | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival (PFS), overall survival (OS), disease control rate neoantigen-specific immune responses immune responses not specific for neoantigen | — |
Countries
Japan
Contacts
Public ContactShigeo Koide
The Jikei University Kashiwa Hospital
Outcome results
None listed