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).

July 18, 2017 updated by: Bayer
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • St Leonards, New South Wales, Australia, 2065
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Heidelberg, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Innsbruck, Austria, 6020
      • Wien, Austria, 1090
  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1200
      • Bruxelles - Brussel, Belgium, 1090
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
  • China
      • Beijing, China, 100021
      • Beijing, China, 100142
      • Shanghai, China, 200032
      • Shanghai, China, 200438
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
      • Guangzhou, Guangdong, China, 510060
    • Shannxi
      • Xi'an, Shannxi, China, 710032
  • France
      • Creteil, France, 94010
      • Lille, France, 59037
      • Lyon, France, 69003
      • Lyon Cedex, France, 69288
      • Marseille, France, 13005
      • Paris, France, 75571
      • Paris, France, 75020
      • Vandoeuvre-les-nancy, France, 54500
      • Villejuif, France, 94800
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Heidelberg, Baden-Württemberg, Germany, 69120
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • Erlangen, Bayern, Germany, 91054
      • München, Bayern, Germany, 81377
      • Regensburg, Bayern, Germany, 93042
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Essen, Nordrhein-Westfalen, Germany, 45136
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Thüringen
      • Jena, Thüringen, Germany, 07743
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
    • Lazio
      • Roma, Lazio, Italy, 00133
      • Roma, Lazio, Italy, 00185
    • Lombardia
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20122
    • Piemonte
      • Torino, Piemonte, Italy, 10126
    • Puglia
      • Bari, Puglia, Italy, 70021
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
    • Toscana
      • Pisa, Toscana, Italy, 56124
    • Veneto
      • Padova, Veneto, Italy, 35128
      • Verona, Veneto, Italy, 37134
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
      • Gyeonggi-do, Korea, Republic of, 411-706
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital, Yonsei University
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 169610
  • Spain
      • A Coruña, Spain, 15006
      • Alicante, Spain, 03010
      • Barcelona, Spain, 08036
      • Córdoba, Spain, 14004
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46014
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • Sabadell, Barcelona, Spain, 08208
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spain, 48903
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital Alcorcon
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, 38320
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10002
  • United States
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90095-7077
      • San Francisco, California, United States, 94115
    • Florida
      • Gainesville, Florida, United States, 32610-0316
      • Miami, Florida, United States, 33136
      • Orlando, Florida, United States, 32804
    • Georgia
      • Atlanta, Georgia, United States, 30309-1231
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0330
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63104
    • New York
      • New York, New York, United States, 10029
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210-1240
    • Oregon
      • Portland, Oregon, United States, 97239
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Washington
      • Seattle, Washington, United States, 98101
      • Seattle, Washington, United States, 98109-1023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.)
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
Placebo Comparator: 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.)
Drug: Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first participant until 28 months later (cut-off date)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.
From randomization of the first participant until 28 months later (cut-off date)
Time to Untreatable Progression (TTUP)
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first participant until 28 months later (cut-off date)
Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first participant until 28 months later (cut-off date)
Tumor Response - Independent Radiological Review
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
From randomization of the first participant until 28 months later (cut-off date)
Tumor Response - Investigator Assessment
Time Frame: From randomization of the first participant until 28 months later (cut-off date)
Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
From randomization of the first participant until 28 months later (cut-off date)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12918
  • 2008-005056-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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