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Hepatocellular carcinoma (HCC) is the most common primary liver tumors. Surgical resection remains the first choice of early stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized that tumor recurrent rate is more than 50% in 5 years although the tumors are completely resected. In our large scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease survival were 73.7%, 58.3% and 53.3%, respectively. Currently there are no effective treatment used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DC) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DC pulsed by tumor associated antigens can be used to proceed tumor-specific immunotherapy. Thereafter, DC pulsed HCC tumor-antigens may be used as an adjuvant therapy to prevent HCC recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure: injection of the cell therapy product | Experimental | Procedures per cycle (total of 3 cycles): 8 days before autologous cell injection: Cytapheresis - Autologous cell injection - 2 days after cell injection: lab assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Dendritic Cell | Biological | Biological: Immunotherapy with dendritic cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | From date of randomization untill the date of radiographic tumor assessment confirm tumor recurrence, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |