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Treatment with chemotherapy and dendritic cells pulsed with neoantigen-specific epitopes for pancreatic cancer. (PK-neoantigen-DCtest)

neoantigen based chemoimmunotherapy (PK-neoantigen-DCtest)

Yoshida Hiroshi

Koido Shigeo

The Jikei University Kashiwa Hospital

163-1 Kashiwashita,Kasiwa-shi,Chiba-ken

shigeo_koido@jikei.ac.jp

Koide Shigeo

The Jikei University Kashiwa Hospital

163-1 Kashiwashita,Kasiwa-shi,Chiba-ken

+81-4-7164-1111

shigeo_koido@jikei.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

The exclusion criteria were pregnancy, serious infections, severe underlying disease, severe allergic disease, and a judgment of unsuitability by the principal investigator.

Both

advanced pancreatic cancer

neoantigen/DC vaccine,Gemcitabine,nab-PTX

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 should be administered as follows as a course of 2 weeks.)
After the cycles of chemotherapy, the patients were treated with a combination of chemotherapy and neoantigen pulsed dendritic cells (neoantigen/DC) vaccine.
The neoantigen/DC vaccine (usually 10,000,000 cells/dose) was intradermally administered biweekly at six different sites (bilateral upper arms, lower abdomen, and femoral regions) regardless of the regimen of chemotherapy.
The patients could receive at least 15 times of neoantigen/DC vaccine until the unacceptable adverse events, or withdrawal of consent.
After disease progression, the patients were permitted to receive the second-line chemotherapy.

pancreatic cancer, neoantigen, dendritic cell, cancer vaccines

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).

progression free survival (PFS), overall survival (OS), disease control rate
neoantigen-specific immune responses
immune responses not specific for neoantigen

Suspended

+81-3-3433-1111

Oct. 05, 2022