This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
iNeo-Vac-P01 (peptides): 300 mcg per peptide
GM-CSF: 40 mcg
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGNumber of participants experiencing clinical and laboratory adverse events (AEs)
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: 1 years
Relapse Free Survival(RFS)
Time from surgery to any recurrence
Time frame: 4 years
Overall Survival(OS)
Time from surgery to death or last follow-up
Time frame: 4 years
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