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

Recruiting now · Phase 4

Conditions studied: Hepatocellular Carcinoma

In brief

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 facts

Study ID

NCT07059494

Run by

Icahn School of Medicine at Mount Sinai

People needed

40

Starts

2026-03-26

Expected to finish

2028-08-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 with an associated pathology report prior to study enrollment. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Availability of a representative tumor specimen for exploratory biomarker research. Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) either outside of the Milan Criteria (MC), or within the MC, with high risk disease as defined by alpha-fetoprotein (AFP) ≥400 ng/mL, and also fulfilling the criteria below.
• Within MC with AFP ≥ 400 ng/ml
• single lesion (≤5cm) or 3 lesions (≤3cm)
• Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging
• Child-Pugh Score of A/B7 (without ascites)
• UNOS-DS Protocol
• HCC exceeding UNOS T2 criteria but meeting one of the following:
• Single lesion ≤ 8 cm
• 2 or 3 lesions each ≤ 5 cm with the sum of the maximal tumor diameters ≤8 cm
• or 5 lesions each ≤ 3 cm with the sum of the maximal tumor diameters ≤ 8 cm
• Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging
• Child-Pugh Score of A/B7 (without ascites)
• Beyond UNOS-DS Liver Only Protocol a. HCC exceeding UNOS-DS criteria by any of the following:
• HCC tumor number
• HCC tumor size
• Total HCC tumor diameter b. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging c. Child-Pugh Score of A/B7 (without ascites)
• Measurable disease, or non-measurable but evaluable disease, per RECIST v1.1 criteria
• Must meet institutional standards for proteinuria (Urinalysis (pH, specific gravity, glucose, protein, ketones, and blood); dipstick permitted
• Eligible for treatment with Y\^90 and atezolizumab plus bevacizumab
• ECOG performance status of 0-1
• Life expectancy > 6 months

You may not qualify if…

• AFP ≥ 1000 ng/ml
• Pathologically mixed tumors, vascular invasion or extra-hepatic disease based on cross-sectional imaging
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• o Participants requiring pain medication must be on a stable regimen at study entry.
• Severe pulmonary disease, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) o Participants with indwelling catheters (e.g., PleurX®) are allowed
• Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, uncontrolled HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (protocol lists a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
• Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
• Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover < 10 percent of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active tuberculosis
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Major surgical procedure, other than for diagnosis or standard HCC care, within 4-6 weeks prior to initiation of study treatment, or during the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to initiation of study treatment
• o Placement of a vascular access device should be at least 2 days prior to initiation of study treatment
• History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival (OS) rate > 90 percent), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, bladder cancer, carcinoma in situ, or Stage I uterine cancer
• Severe active infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, active infection requiring IV antibiotics at the time of initiation of study treatment, or any active infection that could impact participant safety
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• o Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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