Hepatocellular carcinoma
Conditions
Interventions
(TACE using combination of epirubicin and miriplatin) 70mg miriplatin suspended in lipiodol and 20mg epirubicin dissolved in contrast medium are mixed, the preparation is injected through the cathet
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with typical HCC diagnosed by histological or clinical examinations. 2) Patients without candidate for hepatectomy and ablation therapy. 3) Patients who are able to undergo TACE. 4) Child-Pugh score of 7 or less. 5) Patients aged 20 years or over. 6) ECOG performance status of 0-2. 7) Patients with measurable target lesion on Modified RECIST. 8) Patients with at least 4 weeks interval from previous hepatectomy, ablation therapy and TACE. 9) The function of the major organ is kept as satisfied, and laboratory values meet the following criteria within 14 days before study entry. 1.White blood cell>=3,000/mm3 2.Platelet>=50,000/uL 3.Hemogrobin>=8.0g/dL 4.Total serum bilirubin=<2.0mg/dL 5.AST and ALT=<5 times upper limits of normal 6.Prothrombin time(%)>=50% 7.Serum creatinine=<2.0mg/dL 8.No abnormal findings requiring treatment in the electrocardiogram. 10) Patients who are expected to live more than 3 months. 11) Patients obtained written informed consent except following key exclusion criteria.
Exclusion criteria
Exclusion criteria: 1) History of previous treatment by platinum drugs. 2) Extrahepatic metastasis. 3) Advanced vascular or biliary invasion (Vp3, Vp4, Vv3, B3, B4). 4) Severe arterio-portal shunt or arterio-venous shunt. 5) Difficult to perform transcatheter arterial chemotherapy. 6) History of the biliary tract reconstruction or treatment. 7) Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis). 1. Heart failure 2. Renal failure(GFR:<15mL/min/1.73m2) 3. Active infections(except viral hepatitis) 4. Active gastrointestinal bleeding 5. Active duplicative cancer 6. Hepatic encephalopathy or severe mental illness 8) Fever>=38.0 degrees Celsius. 9) History of hypersensitivity to iodine-containing contrast agent, gadolinium-containing contrast agent, epirubicin and platinum-containing drug. 10) Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant. 11) Patients who are concluded to be inappropriate to undergo TACE by angiography. 12) Patients who are concluded to be inappropriate to participate in this study by their physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-tumor effect Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor marker | — |
Countries
Japan
Contacts
Public ContactMasaki Kaibori
Kansai Medical University Department of Surgery
Outcome results
None listed