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Brief Title: 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).
Official Title: 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).
Study ID: NCT00855218
Brief Summary: This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.
Detailed Description: Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, La Jolla, California, United States
, Los Angeles, California, United States
, San Francisco, California, United States
, Gainesville, Florida, United States
, Miami, Florida, United States
, Orlando, Florida, United States
, Atlanta, Georgia, United States
, Ann Arbor, Michigan, United States
, Detroit, Michigan, United States
Abbott Northwestern Hospital, Minneapolis, Minnesota, United States
, Saint Louis, Missouri, United States
, New York, New York, United States
, Cleveland, Ohio, United States
, Columbus, Ohio, United States
, Portland, Oregon, United States
, Richmond, Virginia, United States
, Seattle, Washington, United States
, Seattle, Washington, United States
, Camperdown, New South Wales, Australia
, St Leonards, New South Wales, Australia
, Greenslopes, Queensland, Australia
, Clayton, Victoria, Australia
, Heidelberg, Victoria, Australia
, Melbourne, Victoria, Australia
, Nedlands, Western Australia, Australia
, Innsbruck, , Austria
, Wien, , Austria
, Bruxelles - Brussel, , Belgium
, Bruxelles - Brussel, , Belgium
, Bruxelles - Brussel, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Calgary, Alberta, Canada
, Halifax, Nova Scotia, Canada
, Toronto, Ontario, Canada
, Guangzhou, Guangdong, China
, Guangzhou, Guangdong, China
, Xi'an, Shannxi, China
, Beijing, , China
, Beijing, , China
, Shanghai, , China
, Shanghai, , China
, Creteil, , France
, Lille, , France
, Lyon Cedex, , France
, Lyon, , France
, Marseille, , France
, Paris, , France
, Paris, , France
, Vandoeuvre-les-nancy, , France
, Villejuif, , France
, Villejuif, , France
, Freiburg, Baden-Württemberg, Germany
, Heidelberg, Baden-Württemberg, Germany
, Tübingen, Baden-Württemberg, Germany
, Erlangen, Bayern, Germany
, München, Bayern, Germany
, Regensburg, Bayern, Germany
, Frankfurt, Hessen, Germany
, Hannover, Niedersachsen, Germany
, Essen, Nordrhein-Westfalen, Germany
, Essen, Nordrhein-Westfalen, Germany
, Münster, Nordrhein-Westfalen, Germany
, Mainz, Rheinland-Pfalz, Germany
, Homburg, Saarland, Germany
, Jena, Thüringen, Germany
, Berlin, , Germany
, Hamburg, , Germany
, Napoli, Campania, Italy
, Bologna, Emilia-Romagna, Italy
, Roma, Lazio, Italy
, Roma, Lazio, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Torino, Piemonte, Italy
, Bari, Puglia, Italy
, Palermo, Sicilia, Italy
, Pisa, Toscana, Italy
, Padova, Veneto, Italy
, Verona, Veneto, Italy
, Daegu, , Korea, Republic of
, Gyeonggi-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
, Singapore, , Singapore
, Singapore, , Singapore
, Santiago de Compostela, A Coruña, Spain
Hospital Central de Asturias, Oviedo, Asturias, Spain
, Badalona, Barcelona, Spain
, Sabadell, Barcelona, Spain
, Cruces/Barakaldo, Bilbao, Spain
, Barcelona, Catalunya, Spain
Fundación Hospital Alcorcón, Alcorcón, Madrid, Spain
, La Laguna, Santa Cruz de Tenerife, Spain
, A Coruña, , Spain
, Alicante, , Spain
, Barcelona, , Spain
, Córdoba, , Spain
, Madrid, , Spain
, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
, Taipei, , Taiwan
, Taipei, , Taiwan
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR