Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

October 17, 2023 updated by: Boston Scientific Corporation

A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Not Applicable

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

  • Belgium
      • Bruxelles, Belgium, 1070
        • CUB Hôpital Erasme
      • Liege, Belgium, 4000
        • CHU Liege
  • Canada
      • Montréal, Canada, H2X 3J4
        • CHUM St. Luc
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hspital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre / Royal Victoria Hospital
  • France
      • Bondy, France, 93140
        • Hôpital Jean Verdier
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Creteil, France, 94000
        • APHP Hôpital Henri Mondor
      • Dijon, France, 21000
        • CHU Dijon
      • La Tronche, France, 38700
        • CHU de Grenoble
      • Lyon, France, 69004
        • CHU Lyon - Hopital de la Croix Rousse
      • Lyon, France, 69373
        • Centre Leon-Berard
      • Marseille, France, 13385
        • Hopital de la Timone CHU
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nantes, France, 44093
        • CHU Hôtel-Dieu
      • Nice, France, 06202
        • CHU de Nice
      • Pessac Cedex, France, 33604
        • Hôpital Haut-Lévêque, CHU Bordeaux
      • Poitiers, France, 86000
        • CHU De Poitiers
      • Reims Cedex, France, 51092
        • CHU Reims
      • Rennes Cedex, France, 35042
        • Centre Eugene Marquis
      • Salouël, France, 80480
        • CHU Amiens Picardie - Hopital Sud
      • Strasbourg, France, 67200
        • Hopital de Hautepierre
      • Toulouse, France, 31059
        • Hôpital Purpan
      • Vandoeuvre-les-Nancy, France, 54511
        • Chu Nancy
      • Villejuif, France
        • Hôpital Universitaire Paul Brousse
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Bonn, Germany, 53105
        • Universitatsklinikum Bonn
      • Essen, Germany, 45122
        • Universitaetsklinikum Essen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero -Universitaria di Bologna
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 137-701
        • St. Mary Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • AMC
      • Amsterdam, Netherlands, 1081 HV
        • VUMC
      • Groningen, Netherlands, 9713 GZ
        • UMCG
      • Leiden, Netherlands, 2333 ZA
        • LUMC
      • Maastricht, Netherlands, 6229 HX
        • MUMC
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • Spain
      • Badajoz, Spain, 06006
        • Hospital Infanta Cristina
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clinic i Provincial
      • Barcelona, Spain
        • UDIAT Corporacio Parc Tauli
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Murcia, Spain, 30120
        • Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.
      • Oviedo, Spain, 33011
        • Hosptal Universitario Central de Asturias (nuevo HUCA)
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario
      • Sevilla, Spain, 41013
        • H. Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • New Queen Elizabeth Hospital Birmingham
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooks Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey Country Hospital
      • Liverpool, United Kingdom, L69 3GA
        • Royal Liverpool University Hospital
      • London, United Kingdom, W12 0NN
        • Imperial College London
      • London, United Kingdom, NW3 2QG
        • University College London Cancer Institute
      • London, United Kingdom, SE5 9RS
        • King's College Hospital;
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital, Sheffield
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006-2612
        • Banner - University Medical Center Phoenix
    • Florida
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Evanston, Illinois, United States, 60201
        • NorthShore Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Harper Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Oregon
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • St Marks Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Norfolk, Virginia, United States, 23507
        • Sentra Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • Seattle Cancer Care Alliance/University of Washington Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)
Time Frame: 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 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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP) From Time of Randomization Based on Investigator, According RECIST Criteria.
Time Frame: 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 progression (TTP) will be calculated as the interval between the randomization date and the date of first disease progression, including the appearance of new lesion(s) (per RECIST 1.1) and death for any cause or of last contact for patients alive.
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
Time Frame: 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 progression (TTP) will be calculated as the interval between the randomization date and the date of first disease progression, including the appearance of new lesion(s) and death for any cause or of last contact for patients alive.
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
Time Frame: 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
Objective Response Rate by investigator determination per RECIST 1.1
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

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Collaborators

Biocompatibles UK Ltd

Investigators

  • Principal Investigator: Riad Salem, MD, MBA, Dept of Radiology Northwestern University

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 (Actual)

March 1, 2012

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimated)

March 16, 2012

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS-103

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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