Multicenter Phase Ib/II Study of Yttrium-90 Selective Internal Radiation Therapy Combined With Nivolumab, Ipilimumab, and Lenvatinib for Unresectable Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating a combination treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed surgically. This study focuses on the safety and effectiveness of using Yttrium-90 selective internal radiation therapy (Y90-SIRT) together with the drugs nivolumab, ipilimumab, and lenvatinib. The trial aims to assess short-term outcomes like tumor response and progression-free survival, while putting special attention on overall survival benefits for patients. The treatment begins with Y90-SIRT, followed three weeks later by one of three dose groups receiving nivolumab and varying doses of ipilimumab intravenously every three weeks for up to four cycles. After ipilimumab treatment, nivolumab continues every four weeks for up to two years or until disease progression or unacceptable side effects occur. Lenvatinib is given orally daily alongside nivolumab after stopping ipilimumab, with the dose based on body weight. Participants will be closely monitored for side effects and treatment response using imaging and clinical assessments. The study measures dose-limiting toxicities during the initial treatment cycles and overall tumor response over 24 months. Patients will have regular visits for evaluation, and treatment will be adjusted or stopped if necessary. The total participation period may last up to two years, providing comprehensive data on safety and effectiveness.

A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma