advanced hepatocellular carcinoma
Conditions
Interventions
The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin. Sorafenib 400mg bid. 6 courses of transcatheter arterial infusion of cisplatin every 4-6 weeks.
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for study entry have advanced HCC, for whom surgical resection, local ablation therapy, transcatheter arterial chemoembolization are not indicated. The diagnosis was made by either histologic examination or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA-II level. Eligibility criteria included the following factors: age 20-79 years; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; bidimensionally measurable disease; adequate hematologic function (hemoglobin level >= 8.5 g/dL, neutrophil count >= 1,500 cells/mm3, and platelet count >= 70,000 cells/mm3); adequate hepatic function (serum total bilirubin level <= 2.0 mg/dL, serum albumin level >= 2.8 g/dL, and serum aspartate aminotransferase (AST)/alanine aminotransferase(ALT) levels within 5 times of normal limit, Child-Pugh grade within 7 points); adequate pancreatic function (serum total amylase/lipase levels within 2 times of normal limit); adequate renal function (serum creatinine level within normal limits and creatinine clearance >= 60 mL per minute); Previous local therapy for intrahepatic lesions before this treatment, such as hepatic resection, percutaneous local ablation, or transcatheter arterial chemoembolization, was allowed if it had not been done within the previous 4 weeks. And written informed consent.
Exclusion criteria
Exclusion criteria: The exclusion criteria were history of chemotherapy with sorafenib or cisplatin, active infection, uncontrollable hypertension, severe heart disease, refractory pleural effusion or ascites, severe mental disorder or encephalopathy, active gastroduodenal ulcer or esophageal bleeding, active concomitant malignancy, pregnant and lactating females, females of childbearing age unless using effective contraception, and other serious medical conditions.
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 ContactTakuji Okusaka
National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed