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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07059494
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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 — DRUG
    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.
  • Y^90 Radioembolization — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: participants beyond Milan Criteria upon enrollment
    Atezolizumab and Bevacizumab in Combination with Y\^90 Radioembolization
  • Experimental: Cohort B: participants within Milan Criteria with AFP ≥ 400 ng/ml at enrollment.
    Atezolizumab and Bevacizumab in Combination with Y\^90 Radioembolization

Primary Outcome Measure

Proportion of Participants with Response to treatment [ Time Frame: 9 months from first cycle of Y^90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Parissa Tabrizian (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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