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Unresectable Hepatocellular CarcinomaSTOP-HCCNCT01556490

Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

A study testing TheraSphere in people with Unresectable Hepatocellular Carcinoma, run by Boston Scientific Corporation at 94 sites in 11 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
TheraSphere
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
94 sitesin 11 countries
Study dates
Mar 2012to 30 Apr 2022
Phase
Interventional
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

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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)

Trial locations and contacts

94 sites in 11 countries.

94 sites in 11 countries

France21 sites

  • Hôpital Jean Verdier

    Bondy, 93140

  • CHU Estaing

    Clermont-Ferrand, 63003

  • APHP Hôpital Henri Mondor

    Créteil, 94000

  • CHU Dijon

    Dijon, 21000

  • CHU de Grenoble

    La Tronche, 38700

  • CHU Lyon - Hopital de la Croix Rousse

    Lyon, 69004

  • Centre Léon-Bérard

    Lyon, 69373

  • Hopital de la Timone CHU

    Marseille, 13385

  • Hôpital Saint Eloi

    Montpellier, 34295

  • CHU Hôtel-Dieu

    Nantes, 44093

  • CHU de Nice

    Nice, 06202

  • Hôpital Haut-Lévêque, CHU Bordeaux

    Pessac, 33604

  • CHU de Poitiers

    Poitiers, 86000

  • CHU Reims

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35042

  • CHU Amiens Picardie - Hôpital Sud

    Salouël, 80480

  • Hôpital de Hautepierre

    Strasbourg, 67200

  • Hôpital Purpan

    Toulouse, 31059

  • CHU Nancy

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

  • Hôpital Universitaire Paul Brousse

    Villejuif

Other trials in France

United States20 sites

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Wayne State Harper Hospital

    Detroit, Michigan, 48201

  • Northshore Hospital

    Evanston, Illinois, 60201

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • University of Louisville

    Louisville, Kentucky, 40202

  • Weill Cornell Medical Center

    New York, New York, 10021

  • Sentra Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006-2612

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • St Marks Hospital

    Salt Lake City, Utah, 84124

  • Seattle Cancer Care Alliance/University of Washington Medical Center

    Seattle, Washington, 98195

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Legacy Meridian Park Medical Center

    Tualatin, Oregon, 97062

Other trials in United States

Spain16 sites

  • Hospital Infanta Cristina

    Badajoz, 06006

  • Hospital Clinic i Provincial

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • UDIAT Corporacio Parc Tauli

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

    Murcia, 30120

  • Hosptal Universitario Central de Asturias (nuevo HUCA)

    Oviedo, 33011

  • Hospital Clínico Universitario

    Salamanca, 37007

  • H. Virgen del Rocio

    Seville, 41013

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

United Kingdom11 sites

  • New Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH

  • Addenbrooks Hospital

    Cambridge, CB2 0QQ

  • Edinburgh Cancer Centre

    Edinburgh, EH4 2XU

  • Royal Surrey Country Hospital

    Guildford, GU2 7XX

  • Royal Liverpool University Hospital

    Liverpool, L69 3GA

  • University College London Cancer Institute

    London, NW3 2QG

  • King's College Hospital;

    London, SE5 9RS

  • Imperial College London

    London, W12 0NN

  • Christie Hospital

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Weston Park Hospital, Sheffield

    Sheffield, S10 2SJ

Other trials in United Kingdom

Netherlands6 sites

  • VUMC

    Amsterdam, 1081 HV

  • AMC

    Amsterdam, 1105 AZ

  • UMCG

    Groningen, 9713 GZ

  • LUMC

    Leiden, 2333 ZA

  • MUMC

    Maastricht, 6229 HX

  • Erasmus MC

    Rotterdam, 3015 CE

Other trials in Netherlands

South Korea6 sites

  • St. Mary Hospital

    Daegu, 137-701

  • Kyungpook National University Hospital

    Daegu, 41944

  • Keimyung University Dongsan Medical Center

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

Canada5 sites

  • University of Alberta Hspital

    Edmonton, Alberta, T6G 2B7

  • McGill University Health Centre / Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • CHUM St. Luc

    Montreal, H2X 3J4

  • Toronto General Hospital

    Toronto, Ontario, M5G 1X6

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Germany5 sites

  • Universitätsklinikum Bonn

    Bonn, 53105

  • Universitaetsklinikum Essen

    Essen, 45122

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

    Leipzig, 04103

  • Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

    Tübingen, 72076

Other trials in Germany

Belgium2 sites

  • CUB Hôpital Erasme

    Brussels, 1070

  • CHU Liege

    Liège, 4000

Other trials in Belgium

Italy1 site

  • Azienda Ospedaliero -Universitaria di Bologna

    Bologna, 40138

Other trials in Italy

Singapore1 site

  • National University Hospital

    Singapore, 119228

Other trials in Singapore

About this study

Official title: 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.

Being tested
TheraSphere

What participants receive

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

  • TheraSphereDevice

    Yttrium 90 microspheres

Study groups in NCT01556490
Study groupRoleWhat they receive
Control groupNo interventionStandard-of-care sorafenib, with no added therapy
Treatment groupExperimentalStandard-of-care sorafenib plus TheraSphere
Receives: Device: TheraSphere

What is being measured

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

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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)

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

    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.

    Measured: 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

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

    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.

    Measured: 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

  3. Tumor Response

    Objective Response Rate by investigator determination per RECIST 1.1

    Measured: 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

Timeline

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

  1. First posted16 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01556490
Sponsor's protocol ID
TS-103
Acronym
STOP-HCC
Status last verified
Aug 2023
First submitted
13 Mar 2012
Last updated
8 Nov 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30111528

Questions about this trial

What is this clinical trial studying?

A study testing TheraSphere in people with Unresectable Hepatocellular Carcinoma, run by Boston Scientific Corporation at 94 sites in 11 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 15 inclusion and 30 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in France, United States, Spain, United Kingdom, Netherlands and 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2023). 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?

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). The study lists 2 primary outcomes in all. 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 NCT01556490, 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 8 Nov 2023.

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