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Difficulty of participant enrollment.
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The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein invasion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib | Active Comparator | Sorafenib 400mg po bid |
|
| TACE for HCC with portal vein invasion | Experimental | Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Sorafenib 400mg po bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (Efficacy) | every 6 weeks up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | every 6 weeks up to 3 years | |
| objective tumor response rate | Determined by dynamic-perfusion CT scan at the end of each cycle | every 6 weeks up to 3 years |
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Inclusion Criteria:
80 > Age >= 18 years.
Child-Pugh class A (class B could be included when Childs score is 7).
Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Hwan Yoon, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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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 |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| TACE for HCC with portal vein invasion | Procedure | The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion. |
|
|
| objective tumor control rate | Determined by dynamic-perfusion CT scan at the end of each cycle | every 6 weeks up to 3 years |
| progression-free survival | every 6 weeks up to 3 years |
| the adverse event rate and examine the toxicities | The investigators will evaluate the adverse event according to Common Toxicity Criteria(version 4.0)by National Cancer Institute of National Institutes of Health | every 6 weeks up to 3 years |
| Change of perfusion parameter | every 6 weeks up to 3 years |
| Alpha feto protein (AFP) responsiveness | AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment | every 6 weeks up to 3 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |