A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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This is a single institution, open-label, multi-arm, pilot study of a personalized neoantigen-based dendritic cell (DC) vaccine combined with microwave ablation in subjects with Hepatocellular Carcinoma (HCC). Patients with HKLC stage IIa HCC are eligible for enrollment. In this study, the investigators are looking at the safety, feasibility of the personalized neoantigen-based DC vaccine combined with microwave ablation as well as the T cell immune response to the vaccine.

Official Title
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A Study to Assess the Safety, Feasibility, and Immunogenicity of Personalized Neoantigen-based Dendritic Cell Vaccine in Combination With Microwave Ablation to Treat Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma, Liver Cancer, Adult

Intervention / Treatment
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* Biological: Neoantigen Vaccines
* Procedure: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa. Age is greater than 18 years old, male or female. The tumor size is 3cm-5cm, and the lesions are <3. ECOG score < 2, Child-Pugh classification A or B. The participants freely sign informed consent; Exclusion Criteria: Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent; Portal vein thrombosis or extrahepatic metastases; White blood cell count <2 x 10e9/L, platelet count <40 x 10e9/L, serum creatinine >110 mol/L, aspartate aminotransferase >3 times upper limit, serum bilirubin > 2.5 times upper limit, prothrombin time> 19 seconds. Active uncontrolled infection; Concurrent systemic corticosteroid treatment Primary immunodeficiency or systemic autoimmune disease; being treated with immunosuppressive drugs for other diseases; Clinically significant ischemic heart disease or cardiac failure; The investigator believes that there are other reasons that are not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave Ablation + Neoantigen Vaccines<br>The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines. | Biological: Neoantigen Vaccines<br>* 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.<br>* Other names: Personalized Neoantigen-based Dendritic Cell Vaccine;Procedure: Microwave Ablation<br>* ALL the HCC patients will be treated by Microwave Ablation.<br>|
| Active Comparator: Microwave Ablation<br>The HCC patients will be treated only by Microwave Ablation.No vaccine will be used. | Procedure: Microwave Ablation<br>* ALL the HCC patients will be treated by Microwave Ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis. |  | 2 years | 
| Number of participants alive at 2 years |  | 2 years | 
| Progression-free survival at 2 years |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer