A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
NCT ID: NCT02004210
Last Updated: 2016-04-27
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WITHDRAWN
PHASE3
INTERVENTIONAL
2013-04-30
2018-04-30
Brief Summary
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Detailed Description
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However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs 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 by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The TARE group
transarterial radioembolization group
transarterial radioembolization (TARE)
transarterial radioembolization
The TACE group
Transarterial chemoembolization group
transarterial chemoembolization (TACE)
transarterial chemoembolization
Interventions
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transarterial radioembolization (TARE)
transarterial radioembolization
transarterial chemoembolization (TACE)
transarterial chemoembolization
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
* Patients with single large HCC or multinodular HCC
* Single \& 5cm \< size \< 15cm
* 2-5 nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm
* Infiltrative type \& unilobular involvement on liver MRI
* Segmental or lobar portal vein invasion can be included.
* Age : 20 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
* WBC count ≧ 1,000/mm3
* Absolute neutrophil count \> 500/mm3
* Hb ≧ 7.0 g/dL
* Platelet count \> 100,000 /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 who have received Capecitabine within 8 weeks
* Patients with extrahepatic metastasis
* Main portal vein invasion
* Patients with lymph node metastasis
* Bilobar involvement
* Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count)
* Pregnancy
20 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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TACE_TARE
Identifier Type: -
Identifier Source: org_study_id
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