A phase 1 study of the combination chemotherapy of sorafenib with cisplatin transcatheter arterial infusion for advanced hepatocellular carcinoma.

UMIN ID: UMIN000001496

Registered date:02/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced hepatocellular carcinoma
• Date of first enrollment: 2008/12/01
• Target sample size: 21
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: dose-limiting toxicity, recommended dose, adverse events
• Secondary Outcome: response rate, time to progression, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: The Ministry of Health, Labour and Welfare, Japan