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The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded.
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time,Irreversible electroporation(IRE),which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoKnife LEDC System | Experimental | 90 pulses of 70 microseconds each in duration will be administered per electrode pair |
|
| Control | No Intervention | The patients without any treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoKnife LEDC System | Device | 90 pulses of 70 microseconds each in duration will be administered per electrode pair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. | 1 day post treatment to 14 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. | 30 days (+/- 3 days) post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival (PFS) | 2 years post treatment | |
| Over Survival (OS) | 5 years post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhi l Niu | FUDA Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FUDA Cancer Hospital | Guangzhou | Guangdong | 510665 | China |
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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 |