First Line Hepato Cellular Carcinoma (HCC) (NCT00858871) | Clinical Trial Compass
CompletedPhase 3
First Line Hepato Cellular Carcinoma (HCC)
United States1,714 participantsStarted 2009-05
Plain-language summary
The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologic or cytologic confirmed diagnosis of HCC.
* Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
* Child-Pugh Class A
* ECOG performance status 0-1
* Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
* Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
* Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
* Inability to swallow tablets or untreated malabsorption syndrome
What they're measuring
1
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment