A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

PHASE2CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

July 31, 2011

Study Completion Date

February 28, 2013

Conditions
Carcinoma, Hepatocellular
Interventions
DRUG

Sorafenib (Nexavar, BAY43-9006)

800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead

DRUG

Placebo

4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

Trial Locations (107)

500

Changhua Christian Hospital, Changhua

1070

Bruxelles - Brussel

1090

Vienna

Bruxelles - Brussel

1200

Bruxelles - Brussel

2050

Camperdown

2065

St Leonards

3000

Leuven

3004

Melbourne

3084

Heidelberg

3168

Clayton

4000

Liège

4120

Greenslopes

6009

Nedlands

6020

Innsbruck

10002

Taipei

10029

New York

10126

Turin

11217

Taipei

13005

Marseille

13353

Berlin

14004

Córdoba

15006

A Coruña

15706

Santiago de Compostela

20122

Milan

20133

Milan

20246

Hamburg

23249

Richmond

28034

Madrid

28046

Madrid

28922

Fundación Hospital Alcorcón, Alcorcón

30625

Hanover

32804

Orlando

33006

Hospital Central de Asturias, Oviedo

33136

Miami

35128

Padua

37134

Verona

38320

San Cristóbal de La Laguna

40138

Bologna

41013

Hospital Universitario Virgen del Rocío, Seville

44195

Cleveland

45136

Essen

45147

Essen

46014

Valencia

48149

Münster

48202

Detroit

48903

Cruces/Barakaldo

54500

Vandœuvre-lès-Nancy

55131

Mainz

55407

Abbott Northwestern Hospital, Minneapolis

56124

Pisa

59037

Lille

60590

Frankfurt am Main

63104

St Louis

66421

Homburg

69003

Lyon

69120

Heidelberg

69288

Lyon

70021

Bari

72076

Tübingen

75020

Paris

75571

Paris

79106

Freiburg im Breisgau

80131

Napoli

81377

München

90127

Palermo

91054

Erlangen

92037

La Jolla

93042

Regensburg

94010

Créteil

94115

San Francisco

94800

Villejuif

94805

Villejuif

97239

Portland

98101

Seattle

100021

Beijing

100142

Beijing

119228

Singapore

169610

Singapore

200032

Shanghai

200438

Shanghai

510060

Guangzhou

510080

Guangzhou

710032

Xi'an

90095-7077

Los Angeles

32610-0316

Gainesville

30309-1231

Atlanta

48109-0330

Ann Arbor

43210-1240

Columbus

98109-1023

Seattle

T2N 4N1

Calgary

B3H 2Y9

Halifax

M5G 2N2

Toronto

07743

Jena

00133

Rome

00185

Rome

700-721

Daegu

411-706

Gyeonggi-do

110-744

Seoul

120-752

Seoul

135-710

Seoul

135-720

Gangnam Severance Hospital, Yonsei University, Seoul

08916

Badalona

08208

Sabadell

08035

Barcelona

03010

Alicante

08036

Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY