drugset / Trial / NCT00933816

Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy

NCT00933816

Phase 1/2 Completed 37 enrolled Kindai University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2009-07
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 10 mg/m2 Other
Subject Cisplatin Other / unclassified 20 mg/m2 Other
Subject fluorouracil Small molecule 170 mg/m2 Other
Subject fluorouracil Small molecule 330 mg/m2 Other
Background Sorafenib Small molecule 400 mg Oral