Phase I/II Study of Sorafenib In Combination With Low-dose FP Intraarterial Infusion Chemotherapy (SILIUS)

NCT00933816 Phase 1/Phase 2 COMPLETED

The purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose (Phase II).

Details

Lead sponsor	Kindai University
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	37
Start date	2009-07
Completion	2010-10

Conditions

• Hepatocellular Carcinoma

Interventions

• sorafenib, cisplatin, fluorouracil

Primary outcomes

• Dose limiting toxicity in phase I and Time to progression in Phase II — Every 4 weeks

Countries

Japan