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| Name | Class |
|---|---|
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
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The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.
Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial Ethanol Ablation (TEA) | Other | Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEA | Procedure | Arterial feeders to tumors were identified and catheterized with a microcatheter to a branch supplying a Couinaud segment or subsegmental level for delivery of the therapeutic agent, which was Lipiodol-ethanol mixture at 2:1 ratio by volume for TEA (Lipiodol Ultrafluide, Guerbet, France; Dehydrated alcohol [absolute alcohol], Martindale Pharmaceuticals, United Kingdom). The agents were delivered under fluoroscopic control to completely fill up the vasculature of all tumors. The maximum total volume of Lipiodol-ethanol mixture or cisplatin emulsion to be delivered in one treatment session was 60 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival and treatment-related toxicity | Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3. | Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression(TTP) | TTP was defined as date of treatment to date of first CT evidence of disease progression. Patient death during follow-up without CT progression was censored. | Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months. |
| Progression free survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon CH Yu, MD, FRCR | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinicl Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | Hong Kong | ||||
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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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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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|
PFS was defined as date of treatment to date of either first CT evidence of disease progression or death from any cause. Patients alive and free of progression at the end of follow-up were censored. |
| Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months. |
| Tumor response | Treatment response of individual treated tumor lesions was evaluated with CT and classified according to a system combining the recommendation of European Association for the Study of the Liver and the guidelines of World Health Organization, which was considered a preferred method of response assessment following transarterial or locoregional therapies for HCC. Tumor response was classified into 4 categories: 1) complete response (CR), 2) partial response (PR), 3) static disease (SD), or 4) intralesional progression. | Tumor response is studied at 6 months after treatment |
| Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinsese University of Hong Kong |
| Hong Kong |
| Hong Kong |
| Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | Hong Kong |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |