A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

Last updated: September 14, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disease

Liver Cancer

Liver Disorders

Treatment

Bevacizumab

Atezolizumab

Clinical Study ID

NCT06096779
ML44719
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.

Eligibility Criteria

Inclusion

General Inclusion Criteria:

  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed byhistology/cytology or clinically by American Association for the Study of LiverDiseases (AASLD) criteria in cirrhotic participants

  • Disease that is not amenable to curative surgical and/or locoregional therapies

  • No prior systemic treatment (including systemic investigational agents) for locallyadvanced or metastatic and/or unresectable HCC

  • Measurable disease (at least one untreated target lesion) according to RECIST v1.1

  • ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment

  • Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to studytreatment

  • Adequate hematologic and end-organ function

  • Life expectancy of at least 12 weeks

  • Female participants of childbearing potential must be willing to avoid pregnancy andegg donation

  • Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocytecolony-stimulating factor support

  • Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion

  • Hemoglobin ≥ 80 g/L (8 g/dL) AST and ALT ≤ 5 × upper limit of normal (ULN)

  • Serum bilirubin ≤ 3 × ULN

  • Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)

  • Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months

  • INR ≤2.3

Exclusion

General Exclusion Criteria:

  • Pregnancy or breastfeeding

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies

  • Treatment with investigational therapy within 28 days prior to initiation of studytreatment

  • Treatment with locoregional therapy to liver within 28 days prior to initiation ofstudy treatment, or non-recovery from side effects of any such procedure

  • Treatment with systemic immunostimulatory agents

  • Treatment with systemic immunosuppressive medication

  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation ofstudy treatment

  • Inadequately controlled hypertension

  • Active or history of autoimmune disease or immune deficiency

  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis onscreening chest computed tomography (CT) scan

  • Participants who have a known concurrent malignancy that is progressing or requiresactive treatment, who have not completely recovered from treatment, or who have asignificant malignancy history that, in the opinion of the investigator, shouldpreclude participation.

  • Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonalinhibitors) are not excluded.

  • Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixedcholangiocarcinoma and HCC

  • Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases

  • Prior allogeneic stem cell or solid organ transplantation

  • Actively listed for liver transplantation

  • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)

  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding orthat are at high risk for bleeding

  • A prior bleeding event due to esophageal and/or gastric varices within 6 monthsprior to initiation of study treatment

  • Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of studytreatment

  • Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months ofstudy treatment

  • History, planned, or recommended placement of transjugular intrahepaticportosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable inCohort B.

  • Diagnostic Paracentesis is allowed. Therapeutic Paracentesis within 3 months is anexclusion criteria

  • Participants with ascites controlled on diuretics are allowed.

  • History of spontaneous bacterial peritonitis within last 12 months

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Bevacizumab
Phase: 2
Study Start date:
July 15, 2024
Estimated Completion Date:
November 16, 2026

Study Description

This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.

Connect with a study center

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras 4829037, 00935
    Puerto Rico

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • University of Arizona Cancer Center

    Tucson 5318313, Arizona 5551752 85724
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • University of Southern California-Keck School of Medicine -1975 Zonal Ave

    Los Angeles, California 90089-5601
    United States

    Site Not Available

  • University of Southern California

    Newport Beach, California 92663
    United States

    Site Not Available

  • University of Southern California; Oncology/Hematology

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • University of California Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • California Liver Research Institute

    Pasadena, California 91105-2561
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Stanford Health Care

    Stanford, California 94305
    United States

    Site Not Available

  • Harbor UCLA Medical Center

    Torrance, California 90502-2006
    United States

    Site Not Available

  • Cedars Sinai Comprehensive Transplant Center

    West Hollywood, California 90048-2422
    United States

    Site Not Available

  • UC San Diego Moores Cancer Center

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • University of Southern California-Keck School of Medicine -1975 Zonal Ave

    Los Angeles 5368361, California 5332921 90089-5601
    United States

    Active - Recruiting

  • University of Southern California

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • University of California Irvine Medical Center

    Orange 5379513, California 5332921 92868
    United States

    Completed

  • California Liver Research Institute

    Pasadena 5381396, California 5332921 91105-2561
    United States

    Active - Recruiting

  • University of California Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Stanford Health Care

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • Harbor UCLA Medical Center

    Torrance 5403022, California 5332921 90502-2006
    United States

    Active - Recruiting

  • Cedars Sinai Comprehensive Transplant Center

    West Hollywood 5408076, California 5332921 90048-2422
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers (Williams) - USOR

    Denver, Colorado 80218-1237
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers (Williams) - USOR

    Denver 5419384, Colorado 5417618 80218-1237
    United States

    Active - Recruiting

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Active - Recruiting

  • Washington DC VA Medical Center

    Washington, District of Columbia 20422-0001
    United States

    Site Not Available

  • Washington DC VA Medical Center

    Washington D.C. 4140963, District of Columbia 4138106 20422-0001
    United States

    Active - Recruiting

  • Orlando Health Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Health Inc.

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611-2908
    United States

    Active - Recruiting

  • The Duchossois Center for Advanced Medicine

    Chicago, Illinois 60637-1426
    United States

    Site Not Available

  • University of Illinois Health Outpatient Care Center

    Chicago, Illinois 60612-4795
    United States

    Active - Recruiting

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611-2908
    United States

    Active - Recruiting

  • The Duchossois Center for Advanced Medicine

    Chicago 4887398, Illinois 4896861 60637-1426
    United States

    Active - Recruiting

  • University of Illinois Health Outpatient Care Center

    Chicago 4887398, Illinois 4896861 60612-4795
    United States

    Active - Recruiting

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky 40536-7001
    United States

    Site Not Available

  • University of Kentucky - Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536-7001
    United States

    Active - Recruiting

  • LSU Health Baton Rouge

    Baton Rouge, Louisiana 70805
    United States

    Site Not Available

  • LSU Health Baton Rouge; North Clinic

    Baton Rouge, Louisiana 70805
    United States

    Active - Recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana 70808-4375
    United States

    Active - Recruiting

  • LSU Health Baton Rouge

    Baton Rouge 4315588, Louisiana 4331987 70805
    United States

    Active - Recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge 4315588, Louisiana 4331987 70808-4375
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Active - Recruiting

  • Veterans Affairs Ann Arbor Healthcare System

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Veterans Affairs Ann Arbor Healthcare System

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Saint Luke?s Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke?s Hospital of Kansas City

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

  • MorristownMedicalCenter

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey at University Hospital

    Newark, New Jersey 07103
    United States

    Site Not Available

  • MorristownMedicalCenter

    Morristown 5101427, New Jersey 5101760 07962
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey at University Hospital

    Newark 5101798, New Jersey 5101760 07103
    United States

    Active - Recruiting

  • James J Peters Veterans Administration Medical Center - NAVREF

    Bronx, New York 10468-3904
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Long Island Heart Associates

    Mineola, New York 11501-4298
    United States

    Site Not Available

  • R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS

    New Hyde Park, New York 11042-1118
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016-9451
    United States

    Active - Recruiting

  • Long Island Heart Associates

    Mineola 5127134, New York 5128638 11501-4298
    United States

    Active - Recruiting

  • R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS

    New Hyde Park 5128514, New York 5128638 11042-1118
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York 5128581, New York 5128638 10016-9451
    United States

    Active - Recruiting

  • James J Peters Veterans Administration Medical Center - NAVREF

    The Bronx 5110266, New York 5128638 10468-3904
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dayton VA Medical Center - NAVREF - PPDS

    Dayton, Ohio 45428-9000
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Dayton VA Medical Center - NAVREF - PPDS

    Dayton 4509884, Ohio 5165418 45428-9000
    United States

    Active - Recruiting

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104-5020
    United States

    Site Not Available

  • The University of Oklahoma Health Sciences Center

    Oklahoma City 4544349, Oklahoma 4544379 73104-5020
    United States

    Active - Recruiting

  • Kaiser Permanente Westside Medical Center

    Hillsboro, Oregon 97124-5806
    United States

    Site Not Available

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland, Oregon 97239-3011
    United States

    Site Not Available

  • Kaiser Permanente Westside Medical Center

    Hillsboro 5731371, Oregon 5744337 97124-5806
    United States

    Active - Recruiting

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland 5746545, Oregon 5744337 97239-3011
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

    Pittsburgh 5206379, Pennsylvania 6254927 15240
    United States

    Active - Recruiting

  • The West Clinic (East Campus)

    Germantown, Tennessee 38138-1762
    United States

    Site Not Available

  • Nashville General Hospital at Meharry

    Nashville, Tennessee 37208-2918
    United States

    Site Not Available

  • The West Clinic (East Campus)

    Germantown 4624601, Tennessee 4662168 38138-1762
    United States

    Active - Recruiting

  • Nashville General Hospital at Meharry

    Nashville 4644585, Tennessee 4662168 37208-2918
    United States

    Active - Recruiting

  • Liver Institute at Methodist Dallas

    Dallas, Texas 75203-1260
    United States

    Active - Recruiting

  • Moody Outpatient Center ? Parkland Health

    Dallas, Texas 75235
    United States

    Site Not Available

  • Texas Oncology (Worth) - USOR

    Dallas, Texas 75246-2008
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390-0001
    United States

    Active - Recruiting

  • Texas Oncology - Denison Cancer Center

    Denison, Texas 75020-0084
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Kelsey Research Foundation

    Houston, Texas 77025-1669
    United States

    Active - Recruiting

  • Michael E Debakey VA Medical Center - NAVREF - PPDS

    Houston, Texas 77030-4211
    United States

    Site Not Available

  • Liver Institute at Methodist Dallas

    Dallas 4684888, Texas 4736286 75203-1260
    United States

    Active - Recruiting

  • Moody Outpatient Center ? Parkland Health

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

  • Texas Oncology (Worth) - USOR

    Dallas 4684888, Texas 4736286 75246-2008
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390-0001
    United States

    Active - Recruiting

  • Texas Oncology - Denison Cancer Center

    Denison 4685892, Texas 4736286 75020-0084
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Kelsey Research Foundation

    Houston 4699066, Texas 4736286 77025-1669
    United States

    Active - Recruiting

  • Michael E Debakey VA Medical Center - NAVREF - PPDS

    Houston 4699066, Texas 4736286 77030-4211
    United States

    Active - Recruiting

  • Intermountain Healthcare

    Murray, Utah 84107-5741
    United States

    Site Not Available

  • Intermountain Cancer Center

    Saint George, Utah 84790
    United States

    Site Not Available

  • Intermountain Healthcare

    Murray 5778755, Utah 5549030 84107-5741
    United States

    Active - Recruiting

  • Intermountain Cancer Center

    St. George 5546220, Utah 5549030 84790
    United States

    Active - Recruiting

  • Inova Schar Cancer Institute

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Maryview Hospital, Inc.

    Newport News, Virginia 23602
    United States

    Site Not Available

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia 23226-1925
    United States

    Active - Recruiting

  • VCU Medical Center North Hospital

    Richmond, Virginia 23298-5028
    United States

    Site Not Available

  • Inova Schar Cancer Institute

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • Maryview Hospital, Inc.

    Newport News 4776024, Virginia 6254928 23602
    United States

    Active - Recruiting

  • Bon Secours St. Mary's Hospital

    Richmond 4781708, Virginia 6254928 23226-1925
    United States

    Active - Recruiting

  • VCU Medical Center North Hospital

    Richmond 4781708, Virginia 6254928 23298-5028
    United States

    Active - Recruiting

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington 98101-2756
    United States

    Active - Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle 5809844, Washington 5815135 98101
    United States

    Active - Recruiting

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