Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma
A Phase II Study to Evaluate the Efficacy and Safety of Y-90, Durvalumab, Tremelimumab, and Zanzalintinib in Patients With Unresectable and Locally-Advanced Hepatocellular Carcinoma
Sponsor: OHSU Knight Cancer Institute + Oregon Health and Science University, Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Proportion of progression-free at 6-months
Time frame: From first dose of study intervention, up to 6 months
Secondary Endpoints
Incidence of grade ≥ 3 adverse events (AEs)
Objective response rate
Disease control rate
Eligibility Criteria
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% hepa…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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