Phase II Study Comparing Atezolizumab Plus Cabozantinib or Lenvatinib Versus Cabozantinib or Lenvatinib Alone in Adults With Advanced Liver Cancer Previously Treated with Atezolizumab and Bevacizumab

What this Trial Is About

This trial evaluates treatments for patients with liver cancer that cannot be removed by surgery, has spread locally or to other parts of the body, and who have previously received treatment. It compares the combination of atezolizumab with a multi-kinase inhibitor cabozantinib or lenvatinib against a multi-kinase inhibitor alone. The study focuses on advanced hepatocellular carcinoma that progressed after prior treatment with atezolizumab and bevacizumab, aiming to assess outcomes like survival rates and tumor response. Participants are randomly assigned to one of two treatment groups. In one group, patients receive atezolizumab intravenously every 21 days along with cabozantinib or lenvatinib taken orally daily for 21 days per cycle. The other group receives only cabozantinib or lenvatinib orally in the same schedule. Treatment continues in 21-day cycles until disease progression or unacceptable side effects occur. After treatment ends, patients are followed every 9 weeks for up to two years. During the study, participants undergo evaluations including tumor response assessments using standardized criteria, safety monitoring, and biomarker research. Blood tests, imaging scans, and tissue samples may be collected to monitor health and treatment effects. Researchers measure overall survival, progression-free survival, response rates, duration of response, and adverse events. The total participation may last several years, including treatment and follow-up periods to observe long-term outcomes.

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer