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A Study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab
EU CTIS ID: 2023-503229-21-00
What this study is testing
-To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone, on basis of the overall survival (OS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- Symptomatic, untreated, or actively progressing central nervous system metastases
- History of leptomeningeal disease and hepatic encephalopathy
- History of malignancy other than HCC within 5 years prior to screening
- Significant cardiovascular disease within 3 months prior to initiation of study treatment
- Known allergy or hypersensitivity to any of the investigational medicinal product (IMPs) or constituents of the products
- Treatment with an investigational therapy within 28 days prior to initiation of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Chile
- Saudi Arabia
- Malaysia
- Switzerland
- China
- Philippines
- Israel
- India
- Brazil
- Egypt
- Canada
- Russian Federation
- Ghana
- Taiwan
- Japan
- Turkey
- United Kingdom
- Korea, Republic of
- Costa Rica
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Chile; Saudi Arabia; Malaysia; Switzerland; China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.