Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma
NCT07511504 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-06
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.
Conditions
- Locally Advanced Hepatocellular Carcinoma
- Stage III Hepatocellular Carcinoma AJCC v8
- Stage IV Hepatocellular Carcinoma AJCC v8
- Unresectable Hepatocellular Carcinoma
Interventions
- PROCEDURE
-
Angiogram
Undergo angiogram
- PROCEDURE
-
Biopsy Procedure
Undergo tumor biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo blood and urine sample collection
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Single Photon Emission Computed Tomography
Undergo SPECT
- BIOLOGICAL
-
Tremelimumab
Given IV
- PROCEDURE
-
Yttrium-90 Microsphere Radioembolization
Given via transartieral radioembolization procedure
- DRUG
-
Zanzalintinib
Given PO
Sponsors & Collaborators
-
Oregon Health and Science University
collaborator OTHER - collaborator INDUSTRY
-
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Adel Kardosh · OHSU Knight Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-02
- Primary Completion
- 2027-08-01
- Completion
- 2027-08-01
Countries
- United States
Study Locations
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