Status:
ACTIVE_NOT_RECRUITING
A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT04770896
Start Date
April 26 2021
End Date
June 30 2026
Last Update
November 17 2025
Active Locations (123)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
Uniklinikum Salzburg, LKH
Salzburg, Austria, 5020
3
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100
4
Klinik Favoriten
Vienna, Austria, 1100