Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
NCT ID: NCT01857726
Last Updated: 2016-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-07-31
2016-12-31
Brief Summary
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Detailed Description
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However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.
The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The TACE/TACI combination group
Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
Cisplatin
transarterial chemoinfusion with cisplatin 50-100 mg
The TACE-only group
Transarterial chemoembolization with doxorubicin
Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
Interventions
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Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
Cisplatin
transarterial chemoinfusion with cisplatin 50-100 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
* Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
* Age : 18 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
* WBC count \> 2,000/mm3
* Absolute neutrophil count \> 1,000/mm3
* Hb ≧ 8.0 g/dL
* Platelet count ≧ 50,000 /mm3
* Bilirubin ≦ 3 mg/dL
* Adequate clotting function: INR \< 2.3 or \< 6sec
Exclusion Criteria
* ECOG Performance Status ≧ 3
* Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
* History of organ allograft
* Patients with uncontrolled co-morbidity which needs treatment
* Patients who have received prior systemic chemotherapy
* Patients with extrahepatic metastasis
18 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jung-Hwan Yoon
Professor
Principal Investigators
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Jung-Hwan Yoon, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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PVT_TACE/TACI
Identifier Type: -
Identifier Source: org_study_id
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