A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

This study has been completed.

Study NCT00108953 Information provided by Bayer

First Received: April 21, 2005 Last Updated: April 23, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition:	Carcinoma, Hepatocellular
Interventions:	Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Drug: Doxorubicin/Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment started on 13 Apr 2005 and the last study contact occurred on 11 Apr 2008. The study was conducted at 25 active centers in 6 countries (Argentina, Canada, Hong Kong, Russia, United Kingdom, and United States.)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
140 patients were screened, with 44 screen failures. The ITT population (primary population for efficacy analysis) includes all randomized patients (96). The Safety population includes all patients who received at least 1 dose of study drug (95). The study consists of 2 periods: treatment period (not fixed but ended by any event) and follow-up.

Reporting Groups

	Description
Sorafenib + Doxorubicin	Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Placebo + Doxorubicin	Placebo plus Doxorubicin

Participant Flow for 2 periods

Period: Treatment

[1]	ITT population
[2]	ITT population
[3]	No patient under study medication anymore
[4]	No patient under study medication anymore

Period: Follow-up

[1]	40 out of 47 patients were followed after end of double blind treatment
[2]	45 out of 49 patients were followed after end of double blind treatment

Baseline Characteristics

Reporting Groups

	Description
Sorafenib + Doxorubicin	Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Placebo + Doxorubicin	Placebo plus Doxorubicin

Baseline Measures

	Sorafenib + Doxorubicin	Placebo + Doxorubicin	Total
Number of Participants [units: participants]	47	49	96
Age [units: years] Median ( Full Range )	66 ( 38 to 82 )	65 ( 38 to 81 )	65 ( 38 to 82 )
Gender [units: participants]
Female	16	7	23
Male	31	42	73
Child Pugh Status^[1] [units: participants]
5 (Child-Pugh A)	30	28	58
6 (Child-Pugh A)	17	19	36
7 (Child-Pugh B)	0	2	2
Eastern Cooperative Group performance status (ECOG PS) at study entry^[2] [units: participants]
Grade 0	22	16	38
Grade 1	18	25	43
Grade 2	4	3	7
Grade 3	0	1	1
missing	3	4	7
Tumor burden: Extrahepatic spread^[3] [units: participants]
yes	24	32	56
no	23	17	40
Tumor burden: Macroscopic vascular invasion^[4] [units: participants]
yes	13	16	29
no	33	32	65
missing	1	1	2

[1]	The Child-Pugh score is used to classify the stages of liver cirrhosis, based on clinical diagnosis and laboratory tests. Assessment of good operative risk (A) if 5 or 6 points, moderate risk (B) if 7 to 9 points, and poor operative risk (C) if 10 to 15 points. A “C” classification forecasts a survival of less than 12 months.
[2]	The ECOG PS is an expert rating of cancer patients' daily living abilities, from 0 to 5. 0=Fully active, able to carry on all pre-disease performance without restriction. 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 5=dead.
[3]	Tumor spread outside the liver, which describes an aggressive and advanced tumor pattern.
[4]	Tumor spread into the blood vessels as determined through radiological assessment (e.g., x-ray, imaging), which describes an aggressive and advanced tumor pattern.