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NCT04763408Completed

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)

Source: ClinicalTrials.gov · Last updated 18 Jul 2024

Brief summary (registry, in English)

The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

Status (registry)
Completed
Study type
Observational
Enrollment
335 (actual)
First submitted
17 Feb 2021
Start date
9 Apr 2021
Primary completion date
13 Dec 2023
Lead sponsor
Eisai Inc.
NCT number
NCT04763408

What you commit to

  • Study type: Observational
  • Participants enrolled: 335
  • From 9 Apr 2021 to the primary completion date, 13 Dec 2023
  • 44 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label
  • Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Innsbruck
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InnsbruckAustriaUnknown status
Klinikum Klagenfurt am Woerthersee
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KlagenfurtAustriaUnknown status
Universitätsklinikum St. Pölten
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Sankt PöltenAustriaUnknown status
Medizinische Universitat Wien (Medical University of Vienna)
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ViennaAustriaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Monash Health (Monash Medical Centre)
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ClaytonAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Eisai Trial Site #2
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BerlinGermanyUnknown status
Eisai Trial Site #3
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CologneGermanyUnknown status
Eisai Trial Site #5
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MainzGermanyUnknown status
Eisai Trial Site #6
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MunichGermanyUnknown status
Eisai Trial Site #1
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UlmGermanyUnknown status
Hospital General Universitario de Alicante
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AlicanteSpainUnknown status
C.H. Regional Reina Sofia - PPDS
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CórdobaSpainUnknown status
Hospital Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Universitario de Getafe
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GetafeSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Regional Universitario de Malaga - Hospital General
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MálagaSpainUnknown status
Corporacio Sanitaria Parc Tauli
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SabadellSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
CHUS - H. Clinico U. de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio - PPDS
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SevilleSpainUnknown status
Hospital Universitari i Politecnic La Fe de Valencia
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ValenciaSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Royal Free London NHS Foundation Trust
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LondonUnited KingdomUnknown status
Barts Health NHS Trust - Charterhouse Square
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LondonUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
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BolognaItalyUnknown status
Azienda Ospedaliero Universitaria Di Cagliari
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Monserrato CagliariItalyUnknown status
Ospedale del Mare
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NaplesItalyUnknown status
Fondazione Policlinico Universitario A Gemelli
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RomeItalyUnknown status
Fondazione PTV Policlinico Tor Vergata
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RomeItalyUnknown status
Azienda Ospedaliera San Camillo Forlanini
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RomeItalyUnknown status
Hospital Garcia de Orta
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AlmadaPortugalUnknown status
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
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CoimbraPortugalUnknown status
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
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LisbonPortugalUnknown status
Centro Hospitalar Trás Os Montes E Alto Douro EPE
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Vila RealPortugalUnknown status
Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
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CheboksaryRussiaUnknown status
Karolinska universitetssjukhuset - Huddinge
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StockholmSwedenUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
California Liver Research Institute
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PasadenaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.