RecruitingPhase 4NCT07059494

Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant

A Feasibility Clinical Trial of Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization for Patients With Hepatocellular Carcinoma (HCC) for Liver Transplantation


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

40 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A single institution, single arm, two-cohort feasibility trial to evaluate the combination of locoregional Y\^90 therapy with systemic atezolizumab and bevacizumab, in participants presenting with hepatocellular carcinoma (HCC) 1) within Milan Criteria (MC) with AFP ≥ 400 ng/ml as a means of bridge therapy prior to transplant, 2) beyond the Milan Criteria (MC) (within USCF DS criteria and all comers), as a means of downstaging prior to liver transplantation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — atezolizumab (immunotherapy), bevacizumab (a drug that blocks tumor blood supply), and Y-90 radioembolization (a targeted radiation treatment delivered through the blood vessels to the liver) — in people with liver cancer (hepatocellular carcinoma) who are being evaluated for a liver transplant. **You may be eligible if...** - You are 18 years of age or older - You have been newly diagnosed with liver cancer (hepatocellular carcinoma) confirmed by biopsy - You are being evaluated or listed for a liver transplant - Your liver function meets specific criteria (Child-Pugh A or B7) - Your cancer meets standard transplant listing criteria **You may NOT be eligible if...** - Your liver cancer has spread outside the liver to distant organs - You have severe liver disease (Child-Pugh C) - You have prior treatment for liver cancer - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab is an immune checkpoint inhibitor. It is a monoclonal antibody that works by binding to the protein PD-L1 on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system. It is indicated for usage in Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Hepatocellular Carcinoma (HCC), Melanoma, and Alveolar Soft Part Sarcoma (ASPS).

DRUGBevacizumab

Bevacizumab is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. It is also indicated for the treatment of metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in participants who have progressed on a first-line bevacizumab product-containing regimen.

RADIATIONY^90 Radioembolization

Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to treat cancers in the liver. Tiny beads filled with a radioactive isotope are placed inside the blood vessels that supply a tumor. This blocks the supply of blood to the cancer cells and delivers a high dose of radiation to the tumor while sparing normal tissue. It can help extend the lives of participants with inoperable tumors and improve their quality of life.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT07059494


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