Clinical trial NCT04763408: A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Official title: A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Lenvatinib
Advanced or unresectable carcinoma hepatocellular
E7080
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participant with advanced or unresectable hepatocellular carcinoma.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
timeFrame: Up to 7 years
measure: Number of Participants With SAEs With Lenvatinib
timeFrame: Up to 7 years
measure: Number of Participants With Grade 3 to 5 AEs With Lenvatinib
timeFrame: Up to 7 years
measure: Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
timeFrame: Up to 7 years
Secondary outcomes:
measure: Duration of Lenvatinib and Sorafenib Treatment
timeFrame: Up to 7 years
measure: Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
timeFrame: Up to 7 years
measure: Relative Dose Intensity of Lenvatinib and Sorafenib
timeFrame: Up to 7 years
measure: Overall Survival (OS) For Lenvatinib and Sorafenib
timeFrame: Up to 7 years
measure: Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
timeFrame: Up to 7 years
measure: Number of Participants With Hepatotoxicity TEAEs With Sorafenib
timeFrame: Up to 7 years
measure: Number of Participants With SAEs With Sorafenib
timeFrame: Up to 7 years
measure: Number of Participants With Grade 3 to 5 AEs With Sorafenib
timeFrame: Up to 7 years
measure: Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
state: Victoria
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
state: Tirol
city: Klagenfurt Am Woerthersee
country: Austria
facility: Klinikum Klagenfurt Am Woerthersee
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Köln
country: Germany
facility: Eisai Trial Site #3
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Eisai Trial Site #5
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Eisai Trial Site #2
city: Munich
country: Germany
facility: Eisai Trial Site #6
city: Ulm
country: Germany
facility: Eisai Trial Site #1
city: Napoli
country: Italy
facility: Ospedale del Mare
state: Campania
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
state: Lazio
city: Monserrato Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria Di Cagliari
state: Sardegna
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
state: Setúbal
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Vila Real
country: Portugal
facility: Centro Hospitalar Trás Os Montes E Alto Douro EPE
city: Cheboksary
country: Russian Federation
facility: Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
state: Chuvashskaya Respublika
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
state: Murcia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Córdoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Santiago de Compostela
country: Spain
facility: CHUS - H. Clinico U. de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust - Charterhouse Square
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References: