Hepatocellular carcinoma
Conditions
Interventions
Sorafenib is administered everyday at a dose of 400mg bid one month prior to an initiation of DDP-H, which is infused to the entire liver through a hepatic artery at a rate of 3mg/min in total of 65 m
Sponsors
Niigata Hepatocellular Carcinoma Therapy Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically and/or clinically proven hepatocellular carcinoma except for mixed type. 2)Adequate for none of surgical resection, puncture-based therapies, or transhepatic arterial chemoembolization 3)There are bidimensionally measurable targets in the liver. 4)Age between 20 and 79 years old. 5)ECOG performance status score of 0-2. 6)Sufficient functional reserve of major organs. a)Neutrophil count : 1,500 /mm3 =< b)Platelet count: 50,000 /mm3 =< c)Hemoglobin: 8.0 g/dL =< d)Total bilirubin: 3.0 mg/dL => e)Total amylase in serum: 324 IU/bL => f)Creatinine clearance: 50ml/min =< (adjusted for 1.73m2 of body surface area) 7)Child-Pugh score of equal or less than 7. 8)An internal of 4 or more weeks after latest therapy against hepatocellular carcinoma. 9)A written informed consent from a patient him/her self.
Exclusion criteria
Exclusion criteria: 1)Pleural effusion and/or ascites refractory to treatments. 2)Comorbidity: a)Hyper tension over 100mmHg of diastolic blood pressure under medication. b)Uncontrollable heart failure, angina pectoris or arrhythmia. c)Myocardial infarction within 6 months. d)Brain metastasis. e)Active infectious diseases except for hepatitis. f)Active bleeding from GI tract. g)Active concomitant cancer with invasive nature. h)Severe mental disorder or hepatic encephalopathy. 3)A history of severe allergic reaction against iodine contrast medium and/or platinum agents. 4)A pregnant or lactating female or female of childbearing age unless using effective contraception. 5)Ongoing interferon therapy. 6)Difficulties of oral intake. 7)Other serious conditions judged to be inadequate by a responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity, recommended dose, adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, time to progression, overall survival | — |
Countries
Japan
Contacts
Public ContactHirokazu Kawai
Niigata Hepatocellular Carcinoma Therapy Study Group Excutive office
Outcome results
None listed