Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

NCT ID: NCT01556490

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 526 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2022-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Standard-of-care sorafenib, with no added therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment group

Standard-of-care sorafenib plus TheraSphere

Group Type: EXPERIMENTAL

TheraSphere

Intervention Type: DEVICE

Yttrium 90 microspheres

Interventions

TheraSphere

Yttrium 90 microspheres

Intervention Type: DEVICE

Eligibility 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
• 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

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.
• 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)
• 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 chest, liver or abdomen
• Prior yttrium-90 microsphere treatment to the liver
• Prior treatment with transarterial chemoembolization (TACE) or bland embolization must have occurred >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol. For patients with tumor progression in the treatment field and /or lobe previously treated with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE or bland embolization must have been applied >6 months prior to randomization.
• 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 given for more than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib related toxicity
• Evidence of pulmonary insufficiency or inadequately treated moderate grade or severe/very severe grade 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. Patients infected with HIV can be considered, however, they must be well managed and well controlled with undetectable viral load
• Participation in concurrent clinical trials evaluating treatment intervention(s)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riad Salem, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Dept of Radiology Northwestern University

Locations

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

H Lee Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Northshore Hospital

Evanston, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Wayne State Harper Hospital

Detroit, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Weill Cornell Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Miami Valley Hospital

Dayton, Ohio, United States

Legacy Meridian Park Medical Center

Tualatin, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

St Marks Hospital

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Sentra Norfolk General Hospital

Norfolk, Virginia, United States

Seattle Cancer Care Alliance/University of Washington Medical Center

Seattle, Washington, United States

CUB Hôpital Erasme

Brussels, , Belgium

CHU Liege

Liège, , Belgium

University of Alberta Hspital

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Toronto General Hospital

Toronto, Ontario, Canada

McGill University Health Centre / Royal Victoria Hospital

Montreal, Quebec, Canada

CHUM St. Luc

Montreal, , Canada

Hôpital Jean Verdier

Bondy, , France

CHU Estaing

Clermont-Ferrand, , France

APHP Hôpital Henri Mondor

Créteil, , France

CHU Dijon

Dijon, , France

CHU de Grenoble

La Tronche, , France

CHU Lyon - Hopital de la Croix Rousse

Lyon, , France

Centre Léon-Bérard

Lyon, , France

Hopital de la Timone CHU

Marseille, , France

Hôpital Saint Eloi

Montpellier, , France

CHU Hôtel-Dieu

Nantes, , France

CHU de Nice

Nice, , France

Hôpital Haut-Lévêque, CHU Bordeaux

Pessac, , France

CHU de Poitiers

Poitiers, , France

CHU Reims

Reims, , France

Centre Eugene Marquis

Rennes, , France

CHU Amiens Picardie - Hôpital Sud

Salouël, , France

Hôpital de Hautepierre

Strasbourg, , France

Hôpital Purpan

Toulouse, , France

CHU Nancy

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Hôpital Universitaire Paul Brousse

Villejuif, , France

Universitätsklinikum Bonn

Bonn, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

Leipzig, , Germany

Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

Tübingen, , Germany

Azienda Ospedaliero -Universitaria di Bologna

Bologna, , Italy

VUMC

Amsterdam, , Netherlands

AMC

Amsterdam, , Netherlands

UMCG

Groningen, , Netherlands

LUMC

Leiden, , Netherlands

MUMC

Maastricht, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

National University Hospital

Singapore, , Singapore

St. Mary Hospital

Daegu, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Hospital Infanta Cristina

Badajoz, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

UDIAT Corporacio Parc Tauli

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

Murcia, , Spain

Hosptal Universitario Central de Asturias (nuevo HUCA)

Oviedo, , Spain

Hospital Clínico Universitario

Salamanca, , Spain

H. Virgen del Rocio

Seville, , Spain

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

New Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

Addenbrooks Hospital

Cambridge, , United Kingdom

Edinburgh Cancer Centre

Edinburgh, , United Kingdom

Royal Surrey Country Hospital

Guildford, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

University College London Cancer Institute

London, , United Kingdom

King's College Hospital;

London, , United Kingdom

Imperial College London

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Weston Park Hospital, Sheffield

Sheffield, , United Kingdom

Countries

United States; Belgium; Canada; France; Germany; Italy; Netherlands; Singapore; South Korea; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30111528 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.theraspheretrials.com/stop-hcc

Trial-specific website

Other Identifiers

TS-103

Identifier Type: -

Identifier Source: org_study_id