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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Drug: Lenvatinib; Drug: Sorafenib

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Liverpool, New South Wales, Australia, 1871
      • Liverpool Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health, Monash Medical Centre
• Austria
  • Klagenfurt Am Woerthersee, Austria, 9020
    • Klinikum Klagenfurt am Woerthersee
  • St. Pölten, Austria, 3100
    • Universitätsklinikum St. Pölten
  • Vienna, Austria, 1090
    • Medizinische Universität Wien (Medical University of Vienna)
  • Tirol
    • Innsbruck, Tirol, Austria
      • Universitätsklinikum Innsbruck
• Germany
  • Berlin, Germany
    • Eisai Trial Site #2
  • Munich, Germany
    • Eisai Trial Site #6
  • Ulm, Germany
    • Eisai Trial Site #1
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany
      • Eisai Trial Site #3
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany
      • Eisai Trial Site #5
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • Campania
    • Napoli, Campania, Italy, 80147
      • Ospedale del Mare
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli
    • Roma, Lazio, Italy, 00133
      • Fondazione Ptv Policlinico Tor Vergata
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
  • Sardegna
    • Monserrato Cagliari, Sardegna, Italy, 09042
      • Azienda Ospedaliero Universitaria di Cagliari
• Portugal
  • Coimbra, Portugal
    • Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Vila Real, Portugal, 5000-508
    • Centro Hospitalar Trás Os Montes E Alto Douro EPE
  • Setúbal
    • Almada, Setúbal, Portugal, 2805-267
      • Hospital Garcia de Orta
• Russian Federation
  • Chuvashskaya Respublika
    • Cheboksary, Chuvashskaya Respublika, Russian Federation, 428020
      • Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Córdoba, Spain, 14004
    • C.H. Regional Reina Sofia - PPDS
  • Getafe, Spain
    • Hospital Universitario de Getafe
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Málaga, Spain
    • Hospital Regional Universitario de Malaga - Hospital General
  • Santiago de Compostela, Spain, 15706
    • CHUS - H. Clinico U. de Santiago
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio - PPDS
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa
  • Barcelona
    • Sabadell, Barcelona, Spain
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Murcia
    • El Palmar, Murcia, Spain
      • Hospital Universitario Virgen de La Arrixaca
• Sweden
  • Stockholm, Sweden, 141 86
    • Karolinska Universitetssjukhuset Huddinge
• United Kingdom
  • Birmingham, United Kingdom, B15 2PR
    • University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust - Charterhouse Square
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals NHS Trust
• United States
  • California
    • Pasadena, California, United States, 91105
      • California Liver Research Institute
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-0001
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participant with advanced or unresectable hepatocellular carcinoma.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Lenvatinib; Oral capsules.; Other Names: E7080; Lenvima
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.	Drug: Sorafenib; Oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib		Up to 7 years
Number of Participants With SAEs With Lenvatinib		Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Lenvatinib	AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.	Up to 7 years
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib	Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information.	Up to 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Lenvatinib and Sorafenib Treatment		Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib		Up to 7 years
Relative Dose Intensity of Lenvatinib and Sorafenib	Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.	Up to 7 years
Overall Survival (OS) For Lenvatinib and Sorafenib	OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.	Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib		Up to 7 years
Number of Participants With Hepatotoxicity TEAEs With Sorafenib		Up to 7 years
Number of Participants With SAEs With Sorafenib		Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Sorafenib	AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.	Up to 7 years
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib	Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information.	Up to 7 years

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lenvatinib; Advanced or unresectable carcinoma hepatocellular; E7080
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib; Lenvatinib
• Other Study ID Numbers: E7080-M000-508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No