This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. After receiving information on both treatment options, eligible participants selected, according to their preference, either microwave ablation followed by Neo-DC vaccination or microwave ablation alone
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
HCC (3cm≤D ≤5 cm, fewer than three tumors) patients were treated with Microwave Ablation and 7 courses of neoantigen-based DC vaccines.The first neoantigen-based DC vaccine injection will take place up to 30 days following the completion of Microwave Ablation. The day of the first vaccine injection will be referred to as Day 1.The schedule of vaccination is Day 1, Day 8, Day 15, Day 22, Day 50, Day78, Day106.
ALL the HCC patients will be treated by Microwave Ablation.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Safety of neoantigen-based DC vaccine as measured by the number of subjects experiencing each type of adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 1 years
Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.
Time frame: 2 years
Number of participants alive at 2 years
Time frame: 2 years
Progression-free survival at 2 years
Time frame: 2 years
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