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).
NCT ID: NCT00855218
Last Updated: 2017-08-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
307 participants
INTERVENTIONAL
2009-03-31
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma
NCT00844883
Transarterial Chemoembolization Using Doxorubicin Beads With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
NCT01324076
Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
NCT01839630
Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC
NCT00576056
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
NCT00105443
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sorafenib (Nexavar, BAY43-9006) + TACE
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
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
Placebo + TACE
Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Confirmed Diagnosis of HCC:
* Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria
* HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography \[CT\] scan, Magnetic resonance imaging \[MRI\], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
* Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
* Non-cirrhotic subjects:
For subjects without cirrhosis, histological or cytological confirmation is mandatory
* Documentation of original biopsy for diagnosis is acceptable
* Child Pugh class A without ascites
* Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Exclusion Criteria
* Child Pugh B and C
* Active gastrointestinal bleeding
* Encephalopathy
* Ascites
* Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
St 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
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Liège, , 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
Créteil, , France
Lille, , France
Lyon, , France
Lyon, , France
Marseille, , France
Paris, , France
Paris, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Villejuif, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Hanover, Lower Saxony, Germany
Essen, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Hamburg, , Germany
Bari, Apulia, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Palermo, Sicily, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Verona, Veneto, Italy
Singapore, , Singapore
Singapore, , Singapore
Daegu, , South Korea
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University
Seoul, , South Korea
Santiago de Compostela, A Coruña, Spain
Badalona, Barcelona, Spain
Sabadell, Barcelona, Spain
Cruces/Barakaldo, Bilbao, Spain
Barcelona, Catalonia, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
San Cristóbal de 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
Seville, , Spain
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-005056-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12918
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.