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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

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

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Exelixis

Collaborator