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A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIK Cell | Experimental | Phase I - Three dose levels escalated according to 3+3 rule Phase II - The recommended dose level according to the results from Phase I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIK Cell | Biological | Autologous cytokine-induced killer (CIK) cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Presence or absence of Dose-Limiting Toxicity | 5 Weeks | |
| Phase II: Disease Control Rate | 24 Weeks |
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Inclusion Criteria:
20 to 80 years old men and women;
HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
Patients who are not a transplant candidate;
Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
Patients who have a life expectancy of at least 6 months;
Child-Pugh Class should be A or B;
Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3;
Patients who have clinical laboratory test results as follows:
Written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keanyee Lai | Contact | +886-02-27928987 | laikeanyee@gmail.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| 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 |