Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresect… (NCT07511504) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of progression-free at 6-months
Timeframe: From first dose of study intervention, up to 6 months