A Study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab
Key facts
- Where
- Barcelona, Córdoba, Madrid, Palma, Pamplona, Sabadell, Santiago de Compostela, Valencia és Zaragoza, SpanyolországSee the 12 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Clinica Universidad de NavarraMadrid, SpanyolországNo longer taking part
- Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario HM SanchinarroMadrid, SpanyolországNo longer taking part
- Hospital Son LlatzerPalma, SpanyolországNo longer taking part
- Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
- Parc Tauli Hospital UniversitariSabadell, SpanyolországNo longer taking part
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
- Hospital Unviersitario Miguel ServetZaragoza, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-503229-21-00
- Record updated
- 2026. május 22.
- Original description
-To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone, on basis of the overall survival (OS)Read full original descriptionShow less
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB WITH LENVATINIB OR SORAFENIB VERSUS SORAFENIB OR LENVATINIB ALONE IN HEPATOCELLULAR CARCINOMA PREVIOUSLY TREATED WITH ATEZOLIZUMAB AND BEVACIZUMAB
-To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone, on basis of the overall survival (OS)
Inclusion: Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients; Patients without cirrhosis require histological confirmation of diagnosis. HCC must be unamenable to curative surgical and/or locoregional therapies, or have progressed after surgical and /or locoregional therapies; Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 7 days prior to randomization; Child-Pugh class A within 7 days prior to randomization; Life expectancy of at least 12 weeks; Patients with active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 international units per milliliter (IU/mL) obtained within 28 days prior to initiation of study treatment and received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.
Exclusion: Significant cardiovascular disease within 3 months prior to initiation of study treatment; Treatment with an investigational therapy within 28 days prior to initiation of study treatment; History of leptomeningeal disease and hepatic encephalopathy; History of malignancy other than HCC within 5 years prior to screening; Known allergy or hypersensitivity to any of the investigational medicinal product (IMPs) or constituents of the products; Symptomatic, untreated, or actively progressing central nervous system metastases.