A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
NCT ID: NCT04763408
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
335 participants
OBSERVATIONAL
2021-04-09
2023-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lenvatinib
Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.
Lenvatinib
Oral capsules.
Sorafenib
Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.
Sorafenib
Oral tablets.
Interventions
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Lenvatinib
Oral capsules.
Sorafenib
Oral tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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California Liver Research Institute
Pasadena, California, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Universitätsklinikum Innsbruck
Innsbruck, Tyrol, Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt, , Austria
Universitätsklinikum St. Pölten
Sankt Pölten, , Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, , Austria
Eisai Trial Site #3
Cologne, North Rhine-Westphalia, Germany
Eisai Trial Site #5
Mainz, Rhineland-Palatinate, Germany
Eisai Trial Site #2
Berlin, , Germany
Eisai Trial Site #6
Munich, , Germany
Eisai Trial Site #1
Ulm, , Germany
Ospedale del Mare
Napoli, Campania, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Azienda Ospedaliero Universitaria Di Cagliari
Monserrato Cagliari, Sardinia, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, , Italy
Hospital Garcia de Orta
Almada, Setúbal District, Portugal
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar Trás Os Montes E Alto Douro EPE
Vila Real, , Portugal
Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
Cheboksary, Chuvashskaya Respublika, Russia
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, , Spain
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Barts Health NHS Trust - Charterhouse Square
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Other Identifiers
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E7080-M000-508
Identifier Type: -
Identifier Source: org_study_id
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