NCT07059494

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The researchers propose 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. Participants with macrovascular invasion and extrahepatic disease at diagnosis will be excluded from the study. Participants with AFP \> 1000 ng/ml at diagnosis will be excluded.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	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).
DRUG	Bevacizumab	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.
RADIATION	Y^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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-07-10
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study