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| Name | Class |
|---|---|
| Likang Life Sciences Holdings Limited | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave Ablation + Neoantigen Vaccines | Experimental | The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines. |
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| Microwave Ablation | Active Comparator | The HCC patients will be treated only by Microwave Ablation.No vaccine will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen Vaccines | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Yu, Doctor | Contact | 8610-66939530 | yu-jie301@hotmail.com | |
| Li Chen, Doctor | Contact | 8610-84182969-808 | Chenli@likanglife.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Liang, Doctor | Chinese PLA General Hospial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Microwave Ablation | Procedure | ALL the HCC patients will be treated by Microwave Ablation. |
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| Progression-free survival at 2 years | 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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