Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 combination in advanced hepatocellular carcinoma with portal vein invasion.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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