Icahn School of Medicine at Mount Sinai
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.
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. P…
Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years at time of signing Informed Consent Form * Ability to comply with the study protocol * Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) that is histologically or cytologically confirmed * Availability of a representative tumor specimen that is suitable for determination of PD-L1 status via central testing. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 slides (15 slides preferred) slides containing unstained, freshly cut, serial sections should be submitted along…
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).
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.
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.
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