advanced hepatocellular carcinoma
Conditions
Sponsors
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities 2) no adaptation or no response of resection, liver transplantation and local abration,TACE,HAIC 3) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old 4) Convalescence decided by hepatic leision 5) At least 1 target lesion measurable by RECIST/Modified RECIST 6) Interval of 4 weeks or over between last treatment and present therapy 7) Patients with an ECOG Performance Status (PS) score of 0 or 1,2 8) Patients in Child-Pugh score 8or 9 9) Adequate organ function a) Neutrophil>=1500 /mm3 b)PLT>= 50000 /mm3 c) Hb>= 8.0g/dL d) T-Bil<= 5.0 mg/dL e) AST<= within 5 times of normal limit ALT<= within 5 times of normal limit f) Cre<= within 1.5 times of normal limit g) PT>=40% h) No need of treatment on ECG 10) Life expectancy of at least 3 months 11) Patients obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Severe arterio-portal or arterio-venous shunts in the liver 2) Patinets with difficulty with drug arrival to hepatic lesion 3) Other uncontrolled severe illness. a) With severe cardiac failure b) With severe renal function disease c) With active infectious disease except viral hepatitis. d) With active gastrointestinal hemorrhage e) With active other malignancies. f) With hepatic encephalopathy and severe mental disorder g) With clinically significant refractory ascites or pleural effusion 4) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent. 5) A pregnant woman, or a woman suspected of pregnancy. 6) Patients who are concluded to be inappropriate to participate in this study by their physitians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) overall survival 2) time to progression 3) safety | — |
Countries
Japan
Contacts
Public ContactHiroshi Aikata
Hiroshima University Hospital Department of Gastroenterology and Metabolism
Outcome results
None listed