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Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.
Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Emprint Microwave Ablation system) with 2.45 GHz microwave generator the investigators will use has been approved as safe by the European Union (EU) in 2009 and received Food and Drug Administration (FDA) approval in 2014. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in our hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 1 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave ablation (MWA) | Experimental | Microwave ablation (MWA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation | Device | Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor evaluation | Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI). | 1 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Eastern Cooperative Oncology Group (ECOG) evaluation | Complete an Eastern Cooperative Oncology Group (ECOG) evaluation | up to two years |
| Clinical laboratory assessment | Collect blood sample for hematology evaluation |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for this study:
Exclusion Criteria:
Patients presenting with any of the following will not be enrolled into this study:
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| Name | Affiliation | Role |
|---|---|---|
| Kai-Wen Huang, PhD | National Taiwan University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| up to two years |
| Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation | Subjects will still be followed-up in the event of disease progression in order to document local recurrence. | up to two years |
| Review concomitant medications | Use of medications will be reviewed and recorded | up to two years |
| Assess for presence of adverse events | An adverse event assessment will be performed | up to two years |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |