7 JCI-accredited hospitals 17 hospitals with oncology 65 oncology specialists 19 clinical trials recruiting
Oncology & Cancer Care
Active, closed to enrolmentPhase 3NCT04770896

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

This study is for people with liver cancer (hepatocellular carcinoma) that has grown despite atezolizumab and bevacizumab. It tests whether continuing atezolizumab together with lenvatinib or sorafenib works better than lenvatinib or sorafenib alone.

SponsorHoffmann-La Roche
Study typeInterventional
Started2021-04-26
Primary completion2026-10-14
Planned enrolment557
Sites1 Acıbadem · 123 other

A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

What this study is about

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Conditions
  • Unresectable Hepatocellular Carcinoma
Interventions
  • Atezolizumab
  • Lenvatinib
  • Sorafenib
Primary outcome measures
  • Overall Survival (OS) — Randomization until death from any cause (approximately 42 months)
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
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. * Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR). * At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization * Child-Pugh class A within 7 days prior to randomization * Adequate hematologic and end-organ function
Exclusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. * History of leptomeningeal disease * History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Altunizade Hastanesi, Istanbul

Also running at 123 other sites in 28 countries.

Source: ClinicalTrials.gov NCT04770896 · last updated 2026-08-25 · View registry record ↗