hepatocellular carcinoma
Conditions
Interventions
Lipiodol-TAI using miriplatin The injection of Lipiodol was limited to 6 mL.
Lipiodol+DSM-TAI After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of L
Sponsors
Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven or clinically diagnosed hepatocellular carcinoma. 2) Locally nodular disease without extrahepatic metastasis. 3) No indication for surgical resection and local ablation. 4) No vascular tumor thrombosis (portal vein, hepatic vein, and bile duct). 5) Not remarkable findings of A-V shunt and/or A-P shunt. 6) The emulsion of miriplatin and Lipiodol<= 6 mL: The maximum tumor diameter <= 5 cm and the tumor number <= 5 nodules in the liver. The emulusion of miriplatin and lipiodol > 6 mL: The maxmum tumor diameter <= 10 cm and the tumor number <= 10 nodules in the liver. 7) Do not have effect of pervious treatment. 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9) Child-Pugh score of A or B. 10) Adequate organ and marrow function listed below. (1) leukocyte count >= 3000/mm3 (2) platelet count >= 50000/mm3 (3) hemoglobin level >= 9.5 g/dL (4) total bilirubin <= 3.0 mg/dL (5) serum albumin 2.5-3.5 g/dL (6) serum creatinine level normal upper level (7) BUN <= 25 mg/dL 11) Age >= 20 years old 12) Life expectancy at least 3 months.
Exclusion criteria
Exclusion criteria: 1) Parients with severe complicating disease except chronic hepatitis or liver cirrhosis. 2) Patients with active double cancer. 3) The patient with the anamnesis of the hypersensitivity. 4) A pregnant woman, or woman who may pregnant and who are nursing. 5) Patients who were disqualified by doctor in attendance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response, overall survival, and safety | — |
Countries
Japan
Outcome results
None listed