This research study is evaluating a new type of personalized neoantigen cancer vaccine(iNeo-Vac-P01)combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients. 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
iNeo-Vac-P01: 300 mcg per peptide
GM-CSF: 40 mcg
PD-1: 200mg administered by intravenous infusion every 2 weeks.
Radiofrequency ablation surgery
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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 year
Objective Response Rate
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study.
Time frame: 5 years
Measurement of CD4/CD8 T lymphocyte subsets.
CD4/CD8 T lymphocyte subsets were detected by flow cytometry.
Time frame: 3 years
The IFN-γ T cells responses induced by neoantigen
The response of IFN-γ T cells induced by neoantigen was detected by ELispot.
Time frame: 2 years
Overall Survival(OS)
Time from surgery to death or last follow-up.
Time frame: 5 years
Progression-free Survival(PFS)
Time from surgery to any progression.
Time frame: 3 years
Peripheral blood T cell receptor sequencing analysis
The diversity and clonability of T cells were analyzed by peripheral blood T cell receptor sequencing.
Time frame: 2 years
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