A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma
A Multicenter Phase Ib/II Clinical Study on the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Microspheres in Combination With Nivolumab, Ipilimumab, and Lenvatinib in Patients With Unresectable Hepatocellular Carcinoma
West China Hospital
33 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
This clinical trial was designed to evaluate the safety and efficacy of Y90-SIRT combined with nivolumab, ipilimumab, and lenvatinib in patients with unresectable HCC. In addition to assessing short-term efficacy endpoints, such as ORR and PFS, this trial places particular emphasis on the OS benefit for patients. This study is therefore both novel and innovative.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The phase Ib portion of the trial explores the incidence of dose-limiting toxicity (DLT) in the quadruple therapeutic regimen. Three weeks after receiving Y90-SIRT, the patients are assigned to one of three dose exploration cohorts: (1) nivolumab 1 mg/kg IV every 3 weeks (Q3W) + ipilimumab 1 mg/kg IV Q3W for up to 4 cycles; (2) nivolumab 1 mg/kg IV Q3W + ipilimumab 2 mg/kg IV Q3W for up to 4 cycles; (3) nivolumab 1 mg/kg IV Q3W + ipilimumab 3 mg/kg IV Q3W for up to 4 cycles. After completion of ipilimumab administration, nivolumab is continued at 480 mg IV every 4 weeks (Q4W) until disease progression, unacceptable toxicity, withdrawal of informed consent, or a maximum treatment duration of two years. Lenvatinib is then administered after discontinuation of ipilimumab, in combination with nivolumab, at a dose of 8 mg (body weight \<60 kg) or 12 mg (body weight \>60 kg) orally once daily (PO QD), taken at a fixed time each day, with or without food.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07482059