About this trial
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.
Eligibility criteria
Qualifiers
Participant must provide written informed consent before any study-specific procedures or interventions are performed
Participants aged ≥ 18 years
Body weight > 30 kg
Barcelona Clinic Liver Cancer Stage B or C
Disqualifiers
Another primary tumor
Extrahepatic metastases
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
Note: Eligible participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.
Trial design
Treatments tested in this trial
- Angiogram
- Biopsy Procedure
- Biospecimen Collection
- Computed Tomography
- Durvalumab
- Magnetic Resonance Imaging
- Single Photon Emission Computed Tomography
- Tremelimumab
- Yttrium-90 Microsphere Radioembolization
- Zanzalintinib
Treatment groups
Sponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
Exelixis
Collaborator