Hepatocellular Carcinoma
Conditions
Interventions
Patients with hepatocellular carcinoma recieve combination treatment of miriplratin-iodized-oil suspension injection and radiofrequency ablation. Thirty-two patients with hepatocellular carcinoma wil
Sponsors
Japanese College of Radiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of hepatocellular carcinoma is in untreated segment histologically or radiologically established. 2) Hepatocellular carcinomas are 3 or fewer with a maximum diameter of 3cm or smaller, or a single with a maximum diamter of 5cm or smaller. 3) At least 4 weeks interval from previous treatments. 4) Child-Pugh score is 7 or less. 5) There is no invasion of portal vein, hepatic vein, or bile duct. 6) Liver tumors are not adjacent to the common bile duct or main portal vein. 7) No bile duct abnormality. 8) There is no distant metastasis. 9) Patients are not surgical candidates or they decline surgical intervention. 10) Function of main organs are well preserved. 11) Age of 20 years or older. 12) Performance status is 0 or 1 13) Prognosis is expected 6 months or more 14) Infromed consent is given from the patient.
Exclusion criteria
Exclusion criteria: 1) Artrial-portal or -venous shunting. 2) Hepatic arterial obstruction that may prevent embolization. 3) History of billiary surgery. 4) Tumors are close to the bowel and it is difficult to separate them. 5) Herat failure, Renal failure, and active infection, GI bleeding, double cancers, mental disease. 6) Fever (>38 degree celcius). 7) Allergy to contrast medium, miriplatin or iodized-oil. 8) Pregnant woman or woman who is willing to be pregnant. 9) Other reasons that a primary doctor judges judges as inappropriate for a candidate of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local tumor progression at 2-year | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, feasability, initial response, change of tumor marker, local tumor progression on tumor basis at 2-year, overall survival, overall survival rate at 2-year, Progression free survival, Progression free survival rate at 2-year | — |
Countries
Japan
Contacts
Public ContactTakashi Yamanaka
Mie University School of Medicine Radiology
Outcome results
None listed