Hepatocellular carcinoma
Conditions
Sponsors
Department of Radiology, Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically diagnosed as hepatocellular carcinoma (HCC). 2) No prospective candidate for hepatectomy, local ablation therapy or liver transplantation. 3) Tumor size < 5cm, and tumor number 5 or less. 4) Advanced HCC (BCLC stage-B). 5) Child-Pugh score 7 or lower. 6) Age of 20 years or older. 7) ECOG Performance Status of 0. 8) Existence of mesurable lesion by modified RECIST. 9) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 10) No major organ failure and all the laboratory data, below are conserved. 11) At least 3 months survival expected. 12) Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Extrahepatic metastasis. 2) Diagnostic or suspicious lesion of Portal venous invasion, hepatic venous invasion or bile duct invasion. 3) Post ruputred state of hepatocellular carcinoma 4) Remarkable arterio-portal or arterio-venous shunting. 5) Hepatic artery occlusion or major extrahepatic collaterals interfering effective drug delivery. 6) Post biliary reconstruction state. 7) Refractory ascites or pleural effusion. 8) Comorbid diseases as cardiac failure, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders. 9) Fever (more than 38 degrees Celsius) 10) Allergy to contrast media or anthracycline agents. 11) Pregnant or lactating. 12) Other reasons not indicated to this study judged by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and levels of adverse effects, change of tumor markers, overall survival, 1-year survival rate, 2-year survival rate, progression free survival | — |
Countries
Japan
Contacts
Public ContactMasahiro Horikawa
Juntendo University Hospital Department of Radiology
Outcome results
None listed