Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

NCT01556490 | Completed Results DMC

• 1 other identifier: TS-103
• Study Type: interventional
• Target: 526
• Locations: 11 countries
• Sites: 94

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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)

  Time from randomization until date of death due to any cause as reported by study site.

  From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

• Overall Survival (OS) Per Protocol (PP) Population

  Per Protocol = subset of the mITT population excluding patients with major protocol deviations which may affect the efficacy evaluation.

  From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Secondary Outcomes (3)

• Time to Progression (TTP) From Time of Randomization Based on Investigator, According RECIST Criteria.

  From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

• Time to Untreatable Progression (TTUP) From the Time of Randomization Based One or More of the Following: Investigator Assessment According to RECIST Criteria

  From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

• Tumor Response

  From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Study Arms (2)

Control group

NO INTERVENTION

Standard-of-care sorafenib, with no added therapy

Treatment group

EXPERIMENTAL

Standard-of-care sorafenib plus TheraSphere

Device: TheraSphere

Interventions

TheraSphere DEVICE

Yttrium 90 microspheres

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Eastern Cooperative Oncology Group (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/L or \> 50% prothrombin activity
• Hemoglobin ≥ 8.5 g/dL
• Bilirubin ≤ 2.5 mg/dL
• Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)\< 5 X upper limit of normal
• Amylase or lipase ≤ 2X upper limit of normal
• Serum creatinine ≤ 1.5 X upper limit of normal
• International normalized ratio (INR) \< 2.0

You may not qualify if:

• 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.
• History of organ allograft
• Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension or history of cardiac arrhythmias, congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc \>450ms, evidence of torsades de pointe, 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 Cytochrome P450 (CYP) 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
• Taking any UDP-glucuronosyltransferase (UGT) 1A1 and UGT 1A9 substrates (e.g. irinotecan)
• Taking P-Gp substrates (e.g. Digoxin)

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (94)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006-2612, United States

Location

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Northshore Hospital

Evanston, Illinois, 60201, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Wayne State Harper Hospital

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Legacy Meridian Park Medical Center

Tualatin, Oregon, 97062, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St Marks Hospital

Salt Lake City, Utah, 84124, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Sentra Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Seattle Cancer Care Alliance/University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

University of Alberta Hspital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 1X6, Canada

Location

McGill University Health Centre / Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

CHUM St. Luc

Montreal, H2X 3J4, Canada

Location

Hôpital Jean Verdier

Bondy, 93140, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

APHP Hôpital Henri Mondor

Créteil, 94000, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU de Grenoble

La Tronche, 38700, France

Location

CHU Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Location

Centre Léon-Bérard

Lyon, 69373, France

Location

Hopital de la Timone CHU

Marseille, 13385, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

CHU Hôtel-Dieu

Nantes, 44093, France

Location

CHU de Nice

Nice, 06202, France

Location

Hôpital Haut-Lévêque, CHU Bordeaux

Pessac, 33604, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU Reims

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHU Amiens Picardie - Hôpital Sud

Salouël, 80480, France

Location

Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Hôpital Universitaire Paul Brousse

Villejuif, France

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitaetsklinikum Essen

Essen, 45122, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

Leipzig, 04103, Germany

Location

Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

Tübingen, 72076, Germany

Location

Azienda Ospedaliero -Universitaria di Bologna

Bologna, 40138, Italy

Location

VUMC

Amsterdam, 1081 HV, Netherlands

Location

AMC

Amsterdam, 1105 AZ, Netherlands

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

LUMC

Leiden, 2333 ZA, Netherlands

Location

MUMC

Maastricht, 6229 HX, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

National University Hospital

Singapore, 119228, Singapore

Location

St. Mary Hospital

Daegu, 137-701, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Hospital Infanta Cristina

Badajoz, 06006, Spain

Location

Hospital Clinic i Provincial

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

UDIAT Corporacio Parc Tauli

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

Murcia, 30120, Spain

Location

Hosptal Universitario Central de Asturias (nuevo HUCA)

Oviedo, 33011, Spain

Location

Hospital Clínico Universitario

Salamanca, 37007, Spain

Location

H. Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

New Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Addenbrooks Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Surrey Country Hospital

Guildford, GU2 7XX, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L69 3GA, United Kingdom

Location

University College London Cancer Institute

London, NW3 2QG, United Kingdom

Location

King's College Hospital;

London, SE5 9RS, United Kingdom

Location

Imperial College London

London, W12 0NN, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Weston Park Hospital, Sheffield

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (1)

• Chauhan N, Bukovcan J, Boucher E, Cosgrove D, Edeline J, Hamilton B, Kulik L, Master F, Salem R. Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 15;7(8):e11234. doi: 10.2196/11234.

  PMID: 30111528 DERIVED

Related Links

• Trial-specific website

Limitations and Caveats

There were considerably more patients excluded from the TheraSphere arm than the control arm in the per protocol population, this is based on Major Protocol Deviations many of which were related to non-compliance with treatment regimen.

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Boston Scientific

chantal.laframboise@bsci.com

16138011844

Study Officials

• Riad Salem, MD, MBA

  Dept of Radiology Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-08

Locations

KR (6); ES (16); US (20); GB (11); FR (21); IT (1); SG (1); DE (5); BE (2); NL (6); CA (5)