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| Name | Class |
|---|---|
| Tri-Service General Hospital (TSGH) | OTHER |
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The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in:
This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.
60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IKC and TACE | Experimental | IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization) |
|
| TACE | Active Comparator | TACE (Transcatheter Arterial Chemoembolization) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IKC (Immune Killer Cells) | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of tumor size | Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes | One year |
| Progression-Free Survival (PFS) | The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of immune responses | Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses | One year |
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Inclusion Criteria:
Exclusion Criteria:
Participant of other clinical trial within the past 4 weeks of screening period.
Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
Carriers of HIV or HTLV within the past 4 weeks of screening period.
With Active acute or chronic infection by (investigator's judgement).
Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:
5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
5.2 With previous history of encephalopathy within the past six months.
5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).
Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Executive Assistant | Contact | (02)8981-3333 | 114 | thesteve@ivy-cd56.com |
| Name | Affiliation | Role |
|---|---|---|
| Chung-Bao Hsieh, MD | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri Service General Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| TACE (Transcatheter Arterial Chemoembolization) |
| Procedure |
|
|
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |