Hepatocellular Carcinoma
Conditions
Interventions
sorafenib for 6 months start at 2-8 W after resection
Sponsors
Department of Surgery, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hepatocellular carcinoma (HCC) histologically or clinically diagnosed 2. Patients after macroscopically curative resection for HCC with vascular invasion (Vv2-3), over 7 cm in diameter, or over 2 of tumor-to-nontumor ratio by FDG-PET 3. Patients with Child-Pugh score under 7 and performance status 0 or 1 4. Patients without complication of surgery (2-8 weeks after surgery) 5. adequate bone marrow function (neutrophil count &#8805;1,500/mm3, hemoglobin &#8805;7.5 g/dl, platelet count &#8805;50,000/mm3), liver function (total bilirubin < 1.5 mg/dL, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] &#8804;200 IU/L, Albumin &#8805;3.0 g/dl) 6. Cooperative patients 7. Patients provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous history with sorafenib within 3 months before surgery 2. Allergy with sorafenib 3. age within the childbearing range for women 4. Severe complications 5. Patients with residual tumors 6. Other active malignancies 7. Severe renal disorders 8. Severe bronchial athma 9.severe heart disease; uncontrollable hypertension 10. Uncontrollable ascites 11. History of liver transplantaion 12. Uncontrollable esophageal varix 13. History of hepatic encephalopathy 14. Receiving medical therapy affecting sorafenib 15. Receiving herbal medicine 16. HIV-related disease 17. Patients inappropriate for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP OS Safety | — |
Countries
Japan
Contacts
Public ContactSatoru Seo
Kyoto University Department of Surgery
Outcome results
None listed