OncoMatch/Clinical Trials/NCT07059494
Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant
Is NCT07059494 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Atezolizumab and Bevacizumab for hepatocellular carcinoma.
Treatment: Atezolizumab · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Availability of a representative tumor specimen that is suitable for determination of PD-L1 status via central testing
Required: AFP ≥400 ng/mL (high risk disease) (≥400 ng/mL)
within the MC, with high risk disease as defined by alpha-fetoprotein (AFP) ≥400 ng/mL
Excluded: AFP ≥1000 ng/mL
AFP ≥ 1000 ng/ml [excluded]
Disease stage
Required: Stage OUTSIDE OF THE MILAN CRITERIA, WITHIN THE MILAN CRITERIA WITH HIGH RISK DISEASE (AFP ≥400 NG/ML), EXCEEDING UNOS T2 CRITERIA BUT MEETING UNOS-DS PROTOCOL, EXCEEDING UNOS-DS CRITERIA (LIVER ONLY PROTOCOL)
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: locoregional or systemic therapy
Prior locoregional or systemic therapy [excluded]
Cannot have received: CD137 agonists or immune checkpoint blockade therapies (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cannot have received: systemic immunostimulatory agents (interferon, interleukin 2 [IL-2])
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF-α agents)
Exception: acute, low-dose systemic immunosuppressant medication or a one-time pulse dose; mineralocorticoids; corticosteroids for COPD/asthma; low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions
Cannot have received: investigational therapy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (1500/µL) without G-CSF support (exception: BEN < 1.3 x 10^9/L); Lymphocyte count ≥ 0.5 x 10^9/L (500/µL); Platelet count ≥ 100 x 10^9/L (100,000/µL) without transfusion; Hemoglobin ≥ 90 g/L (9 g/dL) (transfusion permitted)
Kidney function
Serum creatinine ≤ 1.5 x ULN
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 upper limit of normal (ULN); Serum bilirubin ≤ 1.5 x ULN (≤3 x ULN for Gilbert disease); Serum albumin ≥ 25 g/L (2.5 g/dL)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
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