Not Yet RecruitingPhase 2

Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma

United States40 participantsStarted 2026-04-02

Plain-language summary

This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged ≥ 18 years * Body weight \> 30 kg * Patients must have radiologically, or histologically or cytologically confirmed hepatocellular cancer that is not amenable to transplant or resection: * Barcelona Clinic Liver Cancer Stage B or C * Cirrhosis grade of Child-Pugh (CP) A or CP-B7 (excluding albumin-bilirubin \[ALBI\] grade 3) * Fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible * Disease must not be amenable to surgical resection, transplantation, or thermal ablation, or recurrent hepatocellular carcinoma (HCC) after a previous definitive therapy (surgery or thermoablative therapy) * Venous invasion (portal, hepatic, biliary) and infiltrative growth pattern are eligible * Eligible for Y-90 transarterial radioembolization (TARE) based on planning angiogram, with evidence of: * ≥ 30% hepatic reserve (i.e., untreated background liver) AND * Estimated lung exposure \< 30 Gy/ treatment (or 50 Gy cumulative total) * Patients with bi-lobar disease amenable to simultaneous or sequential TARE are eligible * Eastern Cooperative Oncology Group (ECOG) 0 - 1 at enrollment * Recovery to baseline or ≤ grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) from toxicities related to any prior treatments, unless adverse events (AE\[s\]) are clinically non-si…

What they're measuring

Proportion of progression-free at 6-months

Timeframe: From first dose of study intervention, up to 6 months

Trial details

NCT IDNCT07511504

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01