Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Nara Medical University, Department of Radiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with hepatocellular carcinoma that are histologically or clinically confirmed 2) Patients with plethoric lesion that show arterial phase enhancement with dynamic computed tomography or magnetic resonance imaging 3) Patients are unsuitable for resection, transplant, or local ablation therapy 4) Hepatic lesions of therapeutic target exit in only 1 segment or 3 subsegments in the liver 5) Total tumor diameter is less than 6cm 6) Patients who have not received previous treatment for HCC more than 4 weeks ago, have no effects of previous treatment 7) No tumor thrombus in the main trunk and left and right branch of the portal vein 8) Chile Pugh class A or B 9) Organ (bone marrow, heart and kidney)function is maintained fully, patients who fulfill of the inclusion criteria below before registration within 2 weeks WBC, more than 3000 PLT, more than 5 x 104 AST, less than 5 x the upper limit of the normal range ALT, less than 5 x the upper limit of the normal range Total serum Bilirubin, less than 3.0 Serum Creatinine, less than 1.5 Electrocardiography, Patients who have no abnormality to require treatment 10) Performance status score of 2 or less 11) Age more than 20 years old 12) Patients are expected to survive more than 3 months 13) Patients obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have medical history of hypersensitivity of platinum-containing drug. 2) Patients who have medical history of hypersensitivity of iodine containing agent and/or contrast material. 3) Extrahepatic metastasis. 4) Bile duct invasion or vascular invasion. 5) Patients after HCC is ruptured. 6) Patients who have medical history of surgical reconstruction of the biliary tract or endoscopic biliary treatment. 7) Patients who have moderate or severe pleural effusion or ascites to be unresponsive to therapy. 8) Severe arterioportal shunt or arteriovenous shunt in the liver. 9) Patients with following severe complicating disease. - Patients who are difficult to control heart failure, angina or arrhythmia despite treatment - Cardiac infarction within 6 months of onset - Renal failure - Active infections(except viral hepatitis) - Active gastrointestinal bleeding - Active duplicative cancer - Hepatic encephalopathy or severe mental illness 10) Patients who are pregnant, lactating or are suspected to be pregnant. 11) Patients who are concluded to be inappropriate to participate in this study safety by their physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year local disease-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event Disease-free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactHideyuki Nishiofuku
Nara Medical University Radiology
Outcome results
None listed