Carcinoma, HepatocellularSTELLARNCT04763408
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
An observational study of Carcinoma, Hepatocellular, run by Eisai Inc. at 44 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Lenvatinib and Sorafenib
- Type of treatment
- Pill or oral medicine
- How many people
- 335 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 9 Apr 2021to 13 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participant with advanced or unresectable hepatocellular carcinoma.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
44 sites in 10 countries.
44 sites in 10 countries
Spain13 sites
Hospital General Universitario de Alicante
Alicante, 03010
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia
Hospital Universitario de Getafe
Getafe
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Regional Universitario de Malaga - Hospital General
Málaga
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocio - PPDS
Seville
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
Italy6 sites
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Ospedaliero Universitaria Di Cagliari
Monserrato Cagliari, Sardinia, 09042
Ospedale del Mare
Naples, Campania, 80147
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168
Germany5 sites
Eisai Trial Site #2
Berlin
Eisai Trial Site #3
Cologne, North Rhine-Westphalia
Eisai Trial Site #5
Mainz, Rhineland-Palatinate
Eisai Trial Site #6
Munich
Eisai Trial Site #1
Ulm
Austria4 sites
Universitätsklinikum Innsbruck
Innsbruck, Tyrol
Klinikum Klagenfurt Am Woerthersee
Klagenfurt, 9020
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090
Portugal4 sites
Hospital Garcia de Orta
Almada, Setúbal District, 2805-267
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
Coimbra
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar Trás Os Montes E Alto Douro EPE
Vila Real, 5000-508
United Kingdom4 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2PR
Barts Health NHS Trust - Charterhouse Square
London, EC1A 7BE
Royal Free London NHS Foundation Trust
London, NW3 2QG
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United States3 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001
California Liver Research Institute
Pasadena, California, 91105
Montefiore Medical Center
The Bronx, New York, 10467
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Liverpool Hospital
Liverpool, New South Wales, 1871
Russia1 site
Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
Cheboksary, Chuvashskaya Respublika, 428020
About this study
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)
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Lenvatinib, Sorafenib
- Keywords
- Lenvatinib, Advanced or unresectable carcinoma hepatocellular, E7080
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Lenvima, E7080
Oral capsules.
SorafenibDrug
Oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lenvatinib | |
| 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. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
Measured: Up to 7 years
Number of Participants With SAEs With Lenvatinib
Measured: 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.
Measured: 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.
Measured: Up to 7 years
Secondary outcomes (9)
Duration of Lenvatinib and Sorafenib Treatment
Measured: Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
Measured: 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.
Measured: 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.
Measured: Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
Measured: Up to 7 years
Number of Participants With Hepatotoxicity TEAEs With Sorafenib
Measured: Up to 7 years
Number of Participants With SAEs With Sorafenib
Measured: 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.
Measured: 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.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start9 Apr 2021
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763408
- Sponsor's protocol ID
- E7080-M000-508
- Acronym
- STELLAR
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2021
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04763408
- Acronym / sponsor ID
- STELLAR / E7080-M000-508
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Lenvatinib, Advanced or unresectable carcinoma hepatocellular, E7080
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib | – | Drug: LenvatinibParticipants 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. |
| Sorafenib | – | Drug: SorafenibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant with advanced or unresectable hepatocellular carcinoma.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: Lenvima, E7080Oral capsules. | Drug | Lenvatinib |
| SorafenibOral tablets. | Drug | Sorafenib |
Primary outcome
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
Time frame: Up to 7 years
Number of Participants With SAEs With Lenvatinib
Time frame: Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Lenvatinib
Time frame: Up to 7 years
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.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
Time frame: Up to 7 years
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.
9 secondary outcomes
Duration of Lenvatinib and Sorafenib Treatment
Time frame: Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
Time frame: Up to 7 years
Relative Dose Intensity of Lenvatinib and Sorafenib
Time frame: Up to 7 years
Overall Survival (OS) For Lenvatinib and Sorafenib
Time frame: Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
Time frame: Up to 7 years
Number of Participants With Hepatotoxicity TEAEs With Sorafenib
Time frame: Up to 7 years
Number of Participants With SAEs With Sorafenib
Time frame: Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Sorafenib
Time frame: Up to 7 years
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
Time frame: Up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Eisai Inc. at 44 sites in 10 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 2 inclusion and 1 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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, Italy, Germany, Austria, Portugal and 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib (time frame: Up to 7 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.