Hepatocellular carcinoma
Conditions
Interventions
Sorafenib
Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 Years and older. 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI. 4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5) At least 4 weeks since last therapy for HCC. 6) Patients with no sorafenib and a fine-powder formulation of cisplatin therapy. 7) Intrahepatic tumor which affects patient'prognosis. 8) Extrahepatic tumor apread which not affects patient's prognosis. 9)Adequate indication for fine-puwder formulation of cisplatin therapy. 10) ECOG Performance status of 0 or 1. 11) Cirrhotic status of Child-Pugh score 5-7. 12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: Granulocyte >= 1000/mm3 Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl Total serum bilirubin <= 3 mg/dl AST and ALT <= 5 times upper limit of normal Serum creatinine <= 1.5 mg/dl Amylase <= 2 times upper limit of normal 13) Written Informed Consent must be obtained.
Exclusion criteria
Exclusion criteria: 1) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro- intestinal bleeding. 2) Clinically uncontrolled ascites or pleural effusion. 3) Existing of hepatic encephalopathy 4) Serious hypertension. 5) Preexisting of history with severe coronary or cerebral artery diseases. 6) Renal failure. 7) Patients who are pregnant, suspected to be pregnant, or wish to become pregnant. 8) Risk of allergic reactions to the study drugs. 9) Active duplicative cancer 10) Previous malignancy 11) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, 2-year survival, time to progression, response rate, safety | — |
Countries
Japan
Contacts
Public ContactMasaaki Kondo
Yokohama City University Medical Center Gastroenterlogical Center
Outcome results
None listed