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Trial record 1 of 1 for:    ts-103
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Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01556490
Recruitment Status : Recruiting
First Posted : March 16, 2012
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.

Brief Summary:
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

Condition or disease Intervention/treatment Phase
Unresectable Hepatocellular Carcinoma Device: TheraSphere Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
Study Start Date : March 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
No Intervention: Control group
Standard-of-care sorafenib, with no added therapy
Experimental: Treatment group
Standard-of-care sorafenib plus TheraSphere
Device: TheraSphere
Yttrium 90 microspheres



Primary Outcome Measures :
  1. Overall survival [ Time Frame: From time of randomization up to 45 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-related evaluation
  • Male or female patients over 18 years of age
  • Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
  • Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
  • Child Pugh score ≤ 7 points
  • ECOG Performance Status score of ≤ 1
  • Life expectancy of 12 weeks or more
  • Eligible to receive standard-of-care sorafenib
  • Platelet count of > 50 x 10⁹ or > 50% prothrombin activity
  • Hemoglobin ≥ 8.5 g/dL
  • Bilirubin ≤ 2.5 mg/dL
  • ALT and AST< 5 X upper limit of normal
  • Amylase and lipase ≤ 2X upper limit of normal
  • Serum creatinine ≤ 1.5 X upper limit of normal
  • INR < 2.0

Exclusion Criteria:

  • Main portal vein thrombosis
  • Eligible for curative treatment (ablation or transplantation)
  • History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry
  • Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each
  • Risk of hepatic or renal failure
  • Tumor replacement > 70% of total liver volume based on visual estimation by investigator OR tumor replacement >50% of total liver volume in the presence of albumin <3 mg/dL
  • History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically
  • Contraindications to angiography and selective visceral catheterization
  • Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
  • Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
  • Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
  • Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
  • Taking P-Gp substrates (e.g. Digoxin)
  • Prior liver resection must have taken >2 months prior to randomization
  • Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
  • Prior external beam radiation treatment to the liver or abdomen
  • Prior yttrium-90 microsphere treatment to the liver
  • Prior treatment with transarterial chemoembolization (TACE) or bland embolization >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol
  • Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
  • Adverse effects due to prior therapy unresolved at randomization
  • Prior systemic treatment for the treatment of HCC, including sorafenib
  • Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Pregnancy or breast feeding
  • Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive
  • Participation in concurrent clinical trials evaluating treatment intervention(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556490


Contacts
Contact: John Saliba +7 9818816336 John.Saliba@chiltern.com
Contact: Beth Meyer +1 4693230532 Beth.Meyer@Chiltern.com

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Locations
United States, District of Columbia
George Washington University Hospital Withdrawn
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
H Lee Moffitt Cancer Center Completed
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlene del Castillo    312-695-1518    carlene.castillo@northwestern.edu   
Principal Investigator: Laura Kulik, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Lelani Fetrow    312-942-1372    Lelani_C_Fetrow@rush.edu   
Principal Investigator: Sheila Eswaran, MD         
University of Illinois at Chicago Completed
Chicago, Illinois, United States, 60612
Northshore Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Niomi Adams    847-570-3708    nadams@northshore.org   
Principal Investigator: Claus Fimmel, MD         
United States, Indiana
Indiana University School of Medicine Completed
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel, RN    502-629-3383    melissa.schlegel@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
United States, Michigan
Wayne State Harper Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Colette Zack    313-576-9385    zackc@karmanos.org   
Principal Investigator: Philip Philip, MD         
Saint Mary's Healthcare Completed
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Theresa McCabe    507-266-4626    mccabewoollard.theresa@mayo.edu   
Principal Investigator: Lewis Roberts, MD         
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Jamie Stern    212-746-9748    jas2071@med.cornell.edu   
Principal Investigator: Adam Talenfeld, MD         
United States, Ohio
Miami Valley Hospital Completed
Dayton, Ohio, United States, 45409
United States, Oregon
Legacy Meridian Park Medical Center Completed
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nancy Pedano, RTR,CVR,RA    215-955-4129    nancy.pedano@jefferson.edu   
Principal Investigator: Colette Shaw, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Susan Lamson    412-864-3292    lamsons@upmc.edu   
Principal Investigator: David Gellar, MD         
United States, Utah
St Marks Hospital Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Melinda Turpin    801-268-7102    melinda.turpin@mountainstarhealth.com   
Principal Investigator: James Carlisle, MD         
United States, Virginia
University of Virginia Health System Completed
Charlottesville, Virginia, United States, 22908
Sentra Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Denitra M Mack, RN BSN    757-388-5224    dsbrooks@sentara.com   
Principal Investigator: Harlan Vingan, MD         
United States, Washington
Seattle Cancer Care Alliance/University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Sean Park    206-288-6439    parks@seattlecca.org   
Principal Investigator: Guy Johnson, MD         
Principal Investigator: William P Harris, MD         
Belgium
OLV Hospital Aalst Recruiting
Aalst, Belgium, 9300
Contact: Ilse Claessens    +32 53 72 45 02    Ilse.claessens@olvz-aalst.be   
Principal Investigator: Koen dR Hendrickx, MD         
CUB Hôpital Erasme Recruiting
Bruxelles, Belgium, 1070
Contact: Ingrid Develter    +32 2 555 44 55    Ingrid.develter@erasme.ulb.ac.be   
Principal Investigator: Gontran Dr Verset, MD         
CHU Liege Recruiting
Liege, Belgium, 4000
Contact: Sylvie Wertz    0032 4 284 44 95    swertz@chu.ulg.ac.be   
Principal Investigator: Jean Delwaide         
Canada, Alberta
University of Alberta Hspital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Joanne McGoey    780-407-8365    joanne.mcgoey@albertahealthservices.ca   
Principal Investigator: Richard Owen, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Frank Chou    604-875-4111. ext 21726    frank.chou@vch.ca   
Principal Investigator: David Liu, MD         
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: Lou Magdale    416-946-4501 ext 6639    lou.magdale@uhn.ca   
Principal Investigator: Robert Beecroft, MD         
Canada, Quebec
McGill University Health Centre / Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Ayat Salman    514-934-1934 ext 36995    Ayat.Salman@MUHC.MCGILL.CA   
Principal Investigator: David Valenti, MD         
Canada
CHUM St. Luc Recruiting
Montréal, Canada, H2X 3J4
Contact: Josée Gagnon    514-890-8000 ext 35806.    j.gagnon.chum@ssss.gouv.qc.ca   
Principal Investigator: Pierre Perreault         
China
Prince of Wales Hospital Recruiting
Hong Kong, China, 852
Contact: Koh Jane    (852)2632 1142    Jane@clo.cuhk.edu.hk   
Principal Investigator: Simon Yu, Prof         
France
Hôpital Jean Verdier Recruiting
Bondy, France, 93140
Contact: Christelle Violet    : 0033 1 48 02 66 47    arc.hge.jvr@aphp.fr   
Principal Investigator: Jean-Charles Dr NAULT         
APHP Hôpital Henri Mondor Recruiting
Creteil, France, 94000
Contact: Ony Ranaivoson    0033 149 81 21 11 ext 16313    onranaivoson@aphp.fr   
Principal Investigator: Charlotte Costentin, MD         
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Nora Perrot    0033(0)3.80.28.12.66    nora.perrot@chu-dijon.fr   
Principal Investigator: Dr Latournerie, MD         
CHU de Grenoble Recruiting
La Tronche, France, 38700
Contact: Laure Bordy    +33 4 76 76 75 75    lbordy@chu-grenoble.fr   
Principal Investigator: Thomas Decaens         
CHU Lyon - Hopital de la Croix Rousse Recruiting
Lyon, France, 69004
Principal Investigator: Agnès Dr Rode         
Centre Léon-Bérard Recruiting
Lyon, France, 69373
Contact: Pierre Metral    00 33 4.26 55 68 44    Pierre.METRAL@lyon.unicancer.fr   
Principal Investigator: Frank Pilleul         
Hopital de la Timone CHU Recruiting
Marseille, France, 13385
Contact: Elisabeth Castanier    +33 4 91 43 52 47    elisabeth.castanier@ap-hm.fr   
Principal Investigator: Rene Gerolami         
Hôpital Saint Eloi Recruiting
Montpellier, France, 34295
Contact: Perrine Rocher    0033 467 33 75 45    p-rocher@chu-montpellier.fr   
Principal Investigator: George Philippe Pageaux, Prof         
CHU Hôtel-Dieu Recruiting
Nantes, France, 44093
Contact: Helene Auble    +33 2 40 08 75 03    Helene.AUBLE@chu-nantes.fr   
Principal Investigator: Isabelle Archambeaud, MD         
CHU de Nice Recruiting
Nice, France, 06202
Contact: Emmanuelle MOURAUX    +33 4 92 03 94 06    mouraux.e@chu-nice.fr   
Principal Investigator: Patrick Chevallier         
Hôpital Haut-Lévêque, CHU Bordeaux Recruiting
Pessac Cedex, France, 33604
Contact: Elodie Cavillon    +33 5 57 62 34 56    elodie.justin@chu-bordeaux.fr   
Principal Investigator: Jean-Baptiste Hiriart, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Laetitia Rouleau    00 33 5 49 44 30 44 ext 46 036    Laetitia.ROULEAU@chu-poitiers.fr   
Principal Investigator: Christine Silvain, MD         
CHU Reims Recruiting
Reims Cedex, France, 51092
Contact: Thomas Feron    00 33 3.26.83.26.31    tferon@chu-reims.fr   
Principal Investigator: Alexandra Heurgue, MD         
Centre Eugene Marquis Recruiting
Rennes Cedex, France, 35042
Contact: Aurelie Sauvanet    00332 99 25 32 54    a.sauvanet@rennes.unicancer.fr   
Principal Investigator: Marc Pracht, MD         
CHU Amiens Picardie - Hôpital Sud Recruiting
Salouël, France, 80480
Contact: Emilien Colin    : +33 3 22 08 88 67    colin.emilien@chu-amiens.fr   
Principal Investigator: Eric Nguyen-Khac, MD         
Hôpital de Hautepierre Recruiting
Strasbourg, France, 67200
Contact: Abdelaziz Tarif    +33 3 69 55 15 71    abdelaziz.tarif@chru-strasbourg.fr   
Principal Investigator: Michel Dr GREGET         
Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Beatrice Lagarde    335 61 77 95 98    lagarde.b@chu-toulouse.fr   
Principal Investigator: Jean Marie Peron         
CHU Nancy Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Saida Benzerafa    03 83 15 33 61    , benzerafa.s@outlook.fr   
Principal Investigator: Jean-Pierre Bronowicki, MD         
Institut Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact: Coralie Gasc    00 33 1 42 11 54 09    coralie.gasc@gustaveroussy.fr   
Principal Investigator: Thierry Debaere, MD         
Hôpital Universitaire Paul Brousse Recruiting
Villejuif, France
Contact: Mariem Arfaoui    +33 1 45 59 66 74    mariem.arfaoui@aphp.fr   
Principal Investigator: René Dr Adam         
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53105
Contact: Maria Gonzalez-Carmona    0049 228 287 15507    Maria.Gonzalez-Carmona@ukb.uni-bonn.de   
Principal Investigator: Christian Strassburg         
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Hong Grafe    0049 201 723 2032    hong.Grafe@uk-essen.de   
Principal Investigator: Stefan Dr Müller, MD         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Marie-Therese Raatschen    +49 511 532 8063    Raatschen.Marietheres@mh-hannover.de   
Principal Investigator: Arndt Vogel         
Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie Recruiting
Leipzig, Germany, 04103
Contact: Elfi Boxhammer    0049 341 97 16 997    Elfi.Boxhammer@medizin.uni-leipzig.de   
Principal Investigator: Michael Dr Moche, MD         
Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie Recruiting
Tübingen, Germany, 72076
Contact: Petra Engels    0049 7071/2985836    Petra.Engels@med.uni-tuebingen.de   
Principal Investigator: Dr Ketelsen         
Italy
Azienda Ospedaliero -Universitaria di Bologna Recruiting
Bologna, Italy, 40138
Contact: Elena Scandellari    0039 051 214 2647 ext 2307    "elena.scandellari@aosp.bo.it   
Principal Investigator: Rita Golfieri, MD         
Korea, Republic of
St. Mary Hospital Recruiting
Daegu, Korea, Republic of, 137-701
Contact: KyongHee Shin    82-2-2258-1456    drange366@naver.com   
Principal Investigator: Ho Jong Chun         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Un Jung Choi    82-10-9362-0677    pretty9362@naver.com   
Principal Investigator: Byoung Kuk Jang         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Eunjin An    82-10-5121-5043    umni85@nate.com   
Principal Investigator: Won Young Tak         
DaeJeon St.Mary's Hopital Recruiting
Daejeon, Korea, Republic of
Contact: Yun Kyoung Ko    82 10 3441 2290    rbbb8@hanmail.net   
Principal Investigator: Myeong Jun Song         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Moon Joo    82-10-2743-0922    HUCHI79@yuhs.ac   
Principal Investigator: Kwang-Hun Lee         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Anyes Kyung    82-2-2072-0385    anyes1118@hanmail.net   
Principal Investigator: Yoon Jun Kim         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Yeon Won    82-10-8686-1732    syari@yuhs.ac   
Principal Investigator: Jong Yun Won         
Netherlands
VUMC Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Martijn Meijerink    0031 20 4444444    MR.Meijerink@vumc.nl   
Principal Investigator: Martijn Meijerink         
AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Eva van Daalen    0031 20 5668229    e.h.vandaalen@amc.uva.nl   
Principal Investigator: Heinz-Joseph Klumpen         
UMCG Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Jan Bottema    0031 0 3619230    j.t.bottema@umcg.nl   
Principal Investigator: Koert de Jong         
LUMC Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Lyda Beneken    0031 71 5261188    a.beneken_kolmer@lumc.nl   
Principal Investigator: Minneke Coenraad         
MUMC Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Myra Jansen    0031 43 3876517    trialbureau.medischeoncologie@mumc.nl   
Principal Investigator: Judith De Vos-Geelen         
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Laurens Groenendijk    0031 10 7033 612    l.groenendijk@erasmusmc.nl   
Principal Investigator: Dr Adriaan Moelker         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Clarissa Chia    6567723443    clarissa_chia@nuhs.edu.sg   
Principal Investigator: Poh Seng Tan, MD         
Spain
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 06006
Contact: Ines Maria Lopez Ferrer    +34 924218040 ext 48350    ineslopez.tic@gmail.com   
Contact: Paloma Moyano    +34 924218040 ext 48350    anaccg.castillo@gmail.com   
Principal Investigator: Dr Ignacio Delgado Mingorance         
Hospital Clinic i Provincial Recruiting
Barcelona, Spain
Contact: Eva Merino    0034 93 2279235    EVMERINO@clinic.cat   
Principal Investigator: Bruix Dr Jordi         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Rebeca Marin    +34 935537143    RMarin@santpau.cat   
Principal Investigator: Ruben Guerrero         
UDIAT Corporacio Parc Tauli Recruiting
Barcelona, Spain
Contact: Ariadna Figuerola    +34 63 030 8480 ext 22070    AFiguerola@tauli.cat   
Principal Investigator: Eva Criado-Paredes         
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Patricia Aguilar Melero    +34 957 010 286    mabgonsan@gmail.com   
Principal Investigator: Luis Zurera         
Hospital Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Dr Yiliam Fundora    0635050820    fundoraes@hotmail.com   
Principal Investigator: Dr Yiliam Fundora         
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Isabel Rico    +34 609022218    estudiosamatilla@gmail.com   
Principal Investigator: Ana Maria Matilla-Pena         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Cristina Carrera    0034 913368263    cristina.carrera.hryc@gmail.com   
Principal Investigator: Carmen Guillen-Ponce, MD         
Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca. Recruiting
Murcia, Spain, 30120
Contact: Paula Ruiz Carreño    +34 968 36 93 87    dm.oncoarrixaca2@gmail.com   
Contact: Ana Cristina Castillo    +34 968 36 93 87    anaccg.castillo@gmail.com   
Principal Investigator: Antonio Capel Alemán         
Hosptal Universitario Central de Asturias (nuevo HUCA) Recruiting
Oviedo, Spain, 33011
Contact: Andres Castaño Garcia    0034 985 108 000 ext 38667    castaogarcia@gmail.com   
Principal Investigator: Maria Varela, MD         
Hospital Clínico Universitario Recruiting
Salamanca, Spain, 37007
Contact: Dr Juan Carlos Adansa    +34 686 60 90 00    jcadansa@saludcastillayleon.es   
Principal Investigator: Luis Muñoz Bellvis         
H. Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Ricardo Ruiz    +34 655 12 93 28    ricardo.ruiz.hvr@gmail.com   
Principal Investigator: Teresa Ferrer         
Hospital Universitario y Politecnico La Fe Recruiting
Valencia, Spain, 46026
Contact: Amadeo Ten Esteve    +34 961245654    ensayosclinicos_acim_lafe@gva.es   
Principal Investigator: Daniel Dr Perez Enguix         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Contact: Triniad Dr Serrano-Agulló    +34 97 655 6400    tserrano.aullo@gmail.com   
Principal Investigator: Triniad Serrano-Agulló         
United Kingdom
Northern Centre Cancer Care Recruiting
New Castle Upon Tyne, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Jonathan Stoddart    0191 213 8438    Jonathan.Stoddart@nuth.nhs.uk   
Principal Investigator: Kate Sumpter         
Addenbrooks Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Svitlana Iyevkova    0044 1223 216063    svitlana.iyevkova@addenbrookes.nhs.uk   
Principal Investigator: Bristi Basu         
Edinburgh Cancer Centre Recruiting
Edinburgh, United Kingdom, EH4 2XU
Principal Investigator: Alan Christie         
Royal Surrey Country Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Ceri Jamieson    01483 406612      
Principal Investigator: Tony Dhillon, MD         
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L69 3GA
Principal Investigator: Daniel Palmer, MD         
University College London Cancer Institute Recruiting
London, United Kingdom, NW3 2QG
Contact: Sara Hamilton       sarahamilton@nhs.net   
Principal Investigator: Tim Meyer, MD         
King's College Hospital; Recruiting
London, United Kingdom, SE5 9RS
Contact: Jozer Calara    0203 2997666    jozer.calara@nhs.net   
Principal Investigator: Paul Ross         
Imperial College London Recruiting
London, United Kingdom, W12 0NN
Contact: Caroline Ward    0044 020 83833089    caroline.ward@imperial.nhs.uk   
Principal Investigator: Rohini Sharma         
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Julie Royle    0044 161 446 8344    julie.royle@christie.nhs.uk   
Principal Investigator: Richard Hubner         
Weston Park Hospital, Sheffield Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Alison Redfearn    0044 114 226 51 60    a.redfearn@sheffield.ac.uk   
Principal Investigator: Suzanne Darby         
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Riad Salem, MD, MBA Dept of Radiology Northwestern University

Additional Information:
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01556490     History of Changes
Other Study ID Numbers: TS-103
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases