Status:
WITHDRAWN
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combin...
Detailed Description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy. However, HCC patients are diagnosed at advanced stage...
Eligibility Criteria
Inclusion
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- 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
- Child-Pugh score ≧ 7
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01857726
Start Date
July 1 2013
End Date
December 1 2016
Last Update
April 28 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea