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Carcinoma, HepatocellularPhase 2NCT00855218

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).

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 107 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
307 participants
Where
107 sitesin 13 countries
Study dates
Mar 2009to Feb 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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:

Who cannot join

  • 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.

Trial locations and contacts

107 sites in 13 countries.

107 sites in 13 countries

United States18 sites

  • Study site

    Ann Arbor, Michigan, 48109-0330

  • Study site

    Atlanta, Georgia, 30309-1231

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43210-1240

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Gainesville, Florida, 32610-0316

  • Study site

    La Jolla, California, 92037

  • Study site

    Los Angeles, California, 90095-7077

  • Study site

    Miami, Florida, 33136

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Study site

    New York, New York, 10029

  • Study site

    Orlando, Florida, 32804

  • Study site

    Portland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23249

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98101

  • Study site

    Seattle, Washington, 98109-1023

  • Study site

    St Louis, Missouri, 63104

Other trials in United States

Germany16 sites

  • Study site

    Berlin, 13353

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Essen, North Rhine-Westphalia, 45136

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Jena, Thuringia, 07743

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81377

  • Study site

    Münster, North Rhine-Westphalia, 48149

  • Study site

    Regensburg, Bavaria, 93042

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Spain16 sites

  • Study site

    A Coruña, 15006

  • Fundación Hospital Alcorcón

    Alcorcón, Madrid, 28922

  • Study site

    Alicante, 03010

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Catalonia, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Córdoba, 14004

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28046

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Study site

    Valencia, 46014

Other trials in Spain

Italy12 sites

  • Study site

    Bari, Apulia, 70021

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00185

  • Study site

    Turin, Piedmont, 10126

  • Study site

    Verona, Veneto, 37134

Other trials in Italy

France10 sites

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69003

  • Study site

    Lyon, 69288

  • Study site

    Marseille, 13005

  • Study site

    Paris, 75020

  • Study site

    Paris, 75571

  • Study site

    Vandœuvre-lès-Nancy, 54500

  • Study site

    Villejuif, 94800

  • Study site

    Villejuif, 94805

Other trials in France

Australia7 sites

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    St Leonards, New South Wales, 2065

Other trials in Australia

China7 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100142

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200438

  • Study site

    Xi'an, Shannxi, 710032

Other trials in China

South Korea6 sites

  • Study site

    Daegu, 700-721

  • Study site

    Gyeonggi-do, 411-706

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

  • Gangnam Severance Hospital, Yonsei University

    Seoul, 135-720

Other trials in South Korea

Belgium5 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Canada3 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Taiwan3 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 11217

Other trials in Taiwan

Austria2 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Vienna, 1090

Other trials in Austria

Singapore2 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169610

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
Sorafenib (Nexavar, BAY43-9006), Placebo
Keywords
Sorafenib, TACE, DC bead, Combination
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

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

  • PlaceboDrug

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

Study groups in NCT00855218
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006) + TACEExperimentalSorafenib 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.)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
Placebo + TACEPlacebo comparatorPlacebo 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.)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

Secondary outcomes (5)

  1. Overall Survival (OS)

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

  2. Time to Untreatable Progression (TTUP)

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

  3. Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

  4. Tumor Response - Independent Radiological Review

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

  5. Tumor Response - Investigator Assessment

    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.

    Measured: From randomization of the first participant until 28 months later (cut-off date)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2011
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00855218
Sponsor's protocol ID
12918
Other IDs
2008-005056-24, 2008
Status last verified
Jul 2017
First submitted
3 Mar 2009
Last updated
18 Aug 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26809111

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 107 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Germany, Spain, Italy, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) (time frame: From randomization of the first participant until 28 months later (cut-off date)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00855218, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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