RecruitingPhase 1Phase 2NCT07482059

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


Sponsor

West China Hospital

Enrollment

33 participants

Start Date

Feb 1, 2026

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment approach for liver cancer (hepatocellular carcinoma) that cannot be surgically removed. The treatment combines a targeted radiation therapy called Y90-SIRT (tiny radioactive beads delivered directly into the liver's blood supply) with immunotherapy drugs. Researchers want to see if this combination works better than existing options. **You may be eligible if...** - You are aged 18–80 with liver cancer confirmed by imaging or biopsy that cannot be surgically removed - Your liver function is relatively preserved (Child-Pugh class A) - You are in good physical condition (ECOG 0–1) - You have not previously received systemic treatment or radioembolization (Y90) - You do not have cancer outside the liver (except lymph node involvement) - Your blood counts, liver function, and kidneys meet minimum requirements **You may NOT be eligible if...** - Your cancer is too widespread or has spread to blood vessels throughout the liver - You have advanced liver cirrhosis (Child-Pugh class C) - You have serious heart disease or a history of blood clots (stroke, pulmonary embolism) in the past 6 months - You have active hepatitis B, C, or HIV infection - You have had an organ transplant - You have an active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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.

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Interventions

DRUGttrium-90 microspheres in combination with nivolumab, ipilimumab, and lenvatinib in patients with unresectable hepatocellular carcinoma

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)

Study Chair Liu Chang , West China Hospital

Chengdu, Sichuan, China

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NCT07482059


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