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.
- Diseases
- Liver and biliary tract cancer
- 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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Klinikum Klagenfurt am Woerthersee Coordinator of this site? Confirm its status | Klagenfurt | Austria | Unknown status |
| Universitätsklinikum St. Pölten Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Unknown status |
| Medizinische Universitat Wien (Medical University of Vienna) Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Monash Health (Monash Medical Centre) Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Eisai Trial Site #2 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Eisai Trial Site #3 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Eisai Trial Site #5 Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Eisai Trial Site #6 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Eisai Trial Site #1 Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| C.H. Regional Reina Sofia - PPDS Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga - Hospital General Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Corporacio Sanitaria Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| CHUS - H. Clinico U. de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio - PPDS Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitari i Politecnic La Fe de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust - Charterhouse Square Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Di Cagliari Coordinator of this site? Confirm its status | Monserrato Cagliari | Italy | Unknown status |
| Ospedale del Mare Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fondazione Policlinico Universitario A Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Fondazione PTV Policlinico Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliera San Camillo Forlanini Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Hospital Garcia de Orta Coordinator of this site? Confirm its status | Almada | Portugal | Unknown status |
| Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Centro Hospitalar Trás Os Montes E Alto Douro EPE Coordinator of this site? Confirm its status | Vila Real | Portugal | Unknown status |
| Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar Coordinator of this site? Confirm its status | Cheboksary | Russia | Unknown status |
| Karolinska universitetssjukhuset - Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| California Liver Research Institute Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.