advanced hepatocellular carcinoma
Conditions
Interventions
Hepatic arterial infusion chemotherapy (Low-Dose FP) Patients become refractory HAIC , followed by sorafenib.
Sponsors
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
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 hepatic arterial infusion chemotherapy. 7) Intrahepatic tumor which affects patient'prognosis. 8) Extrahepatic tumor apread which not affects patient's prognosis. 9) ECOG Performance status of 0 or 1. 10) Child-Pugh 5,6,7 12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: Granulocyte >= 3000/mm3 Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl Total serum bilirubin <= 3 mg/dl serum albimin>=2.8 Serum creatinine <= 1.5 mg/dl prothrombin consumption test>=50% Amylase <= 2 times upper limit of normal 12) Written Informed Consent must be obtained.
Exclusion criteria
Exclusion criteria: 1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP. 7) With severe bone marrow supression. 8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro- intestinal bleeding. 9) Serious hypertension 10) 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 |
|---|---|
| The 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The 2-year survival rate Over all survival Respose rate of HAIC Survival rate according to HAIC response Time to progression of HAIC Response rate of sorafenib Survival rate according to sorafenib response Adverse events Liver function process | — |
Countries
Japan
Contacts
Public ContactHiroshi Aikata
Hiroshima University Hospital Department of Gastroenterology and Metabolism
Outcome results
None listed