Clinical trial NCT00855218: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: Sorafenib
TACE
DC bead
Combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
* 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:

* Patients on a liver transplantation list or with advanced liver disease as defined below:
* 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.

Primary outcomes:
measure: Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
measure: Time to Untreatable Progression (TTUP)
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
measure: Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
measure: Tumor Response - Independent Radiological Review
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
measure: Tumor Response - Investigator Assessment
timeFrame: From randomization of the first participant until 28 months later (cut-off date)
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Camperdown
country: Australia
state: New South Wales
city: St Leonards
country: Australia
state: New South Wales
city: Greenslopes
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Xi'an
country: China
state: Shannxi
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Creteil
country: France
city: Lille
country: France
city: Lyon Cedex
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris
country: France
city: Paris
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
city: Villejuif
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Palermo
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Cruces/Barakaldo
country: Spain
state: Bilbao
city: Barcelona
country: Spain
state: Catalunya
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
state: Madrid
city: La Laguna
country: Spain
state: Santa Cruz de Tenerife
city: A Coruña
country: Spain
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.