drugset

drugset / Trial / NCT00703365

Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)

NCT00703365 ↗

Phase 2 Completed 45 enrolled Mahidol University Bayer · collab Bumrungrad International Hospital · collab Chulalongkorn University · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.

Timeline

Start: 2008-02
Primary completion: 2010-01
Completion: 2011-08

Publications

Background Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Sorafenib	Small molecule	400 mg	Oral

Indications