Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07059494

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-23

40

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed Informed Consent Form
  • Age 18 years or older at time of consent
  • Ability to follow the study protocol
  • Newly diagnosed, biopsy-confirmed hepatocellular carcinoma (HCC)
  • Availability of tumor tissue for PD-L1 testing
  • HCC within Milan Criteria with AFP  400 ng/ml, single lesion  5 cm or up to 3 lesions  3 cm, no vascular invasion or extrahepatic disease, Child-Pugh Score A or B7 without ascites
  • HCC exceeding UNOS T2 criteria but meeting specific size and number limits per UNOS-DS Protocol, no vascular invasion or extrahepatic disease, Child-Pugh Score A or B7 without ascites
  • HCC beyond UNOS-DS criteria with liver-only disease, no vascular invasion or extrahepatic disease, Child-Pugh Score A or B7 without ascites
  • Measurable or evaluable disease per RECIST v1.1
  • Meet institutional standards for proteinuria
  • Eligible for Y^90 and atezolizumab plus bevacizumab treatment
  • ECOG performance status 0-1
  • Life expectancy greater than 6 months
  • Adequate blood counts and organ function within 14 days before treatment
  • Controlled or absent HIV, HCV, and HBV infections
  • Negative pregnancy test for participants who can become pregnant
  • Agreement to abstain or use contraception during the study
Not Eligible

You will not qualify if you...

  • AFP greater than or equal to 1000 ng/ml
  • Mixed tumor types, vascular invasion, or cancer spread outside the liver
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Severe lung disease or fluid buildup requiring frequent drainage
  • Uncontrolled or symptomatic high calcium levels
  • Active or history of autoimmune diseases with some exceptions
  • History of certain lung diseases or active lung inflammation
  • Active tuberculosis
  • Significant heart disease or recent heart attack or stroke
  • Recent major surgery or biopsy within specified timelines
  • Recent or active severe infections
  • Recent treatment with investigational drugs
  • Prior immune checkpoint or related therapies
  • Recent use of systemic immunostimulatory or immunosuppressive medications with exceptions
  • Severe allergic reactions to antibodies or study drugs
  • Prior locoregional or systemic cancer therapy
  • Pregnancy, breastfeeding, or planning pregnancy during or shortly after treatment
  • Poorly controlled high blood pressure or related serious vascular conditions
  • History of serious blood clots or bleeding disorders
  • Recent serious gastrointestinal problems
  • Serious wounds, ulcers, or untreated fractures
  • Recent use of high-dose aspirin or clopidogrel
  • Use of certain blood thinners not recommended due to bleeding risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

Loading map...

Research Team

B

Brandy Haydel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here