RecruitingPhase 2NCT06096779

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

A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Sponsor

Genentech, Inc.

Enrollment

30 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether the immunotherapy drug atezolizumab, with or without bevacizumab (a drug that cuts off blood supply to tumors), can safely and effectively treat patients with unresectable liver cancer (hepatocellular carcinoma) who have moderate liver disease classified as Child-Pugh B7 or B8 — a group that is typically excluded from most liver cancer trials. **You may be eligible if...** - You have been diagnosed with locally advanced, metastatic, or unresectable liver cancer (HCC) confirmed by biopsy or standard imaging criteria - Your liver disease is classified as Child-Pugh B7 or B8 (moderate liver function impairment due to cirrhosis) - You have not received prior systemic treatment for your liver cancer - You have at least one measurable tumor on imaging - You are in reasonably good health (ECOG 0-2) **You may NOT be eligible if...** - You have received prior systemic therapy for this liver cancer - Your liver disease is Child-Pugh A or C - You have significant autoimmune disease or are on long-term steroids - You are pregnant or breastfeeding - You have uncontrolled hypertension or recent major bleeding events Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

DRUGBevacizumab

Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle.

Locations(61)

University of Arizona Cancer Center

Tucson, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

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

Los Angeles, California, United States

University of Southern California

Newport Beach, California, United States

University of California Irvine Medical Center

Orange, California, United States

California Liver Research Institute

Pasadena, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Stanford Health Care

Stanford, California, United States

Harbor UCLA Medical Center

Torrance, California, United States

Cedars Sinai Comprehensive Transplant Center

West Hollywood, California, United States

Rocky Mountain Cancer Centers (Williams) - USOR

Denver, Colorado, United States

Hartford Healthcare Cancer Institute at Hartford Hospital

Hartford, Connecticut, United States

Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Orlando Health Inc.

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois Health Outpatient Care Center

Chicago, Illinois, United States

The Duchossois Center for Advanced Medicine

Chicago, Illinois, United States

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, United States

LSU Health Baton Rouge

Baton Rouge, Louisiana, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Saint Luke?s Hospital of Kansas City

Kansas City, Missouri, United States

MorristownMedicalCenter

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey at University Hospital

Newark, New Jersey, United States

Long Island Heart Associates

Mineola, New York, United States

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

New Hyde Park, New York, United States

NYU Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Dayton VA Medical Center - NAVREF - PPDS

Dayton, Ohio, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Kaiser Permanente Westside Medical Center

Hillsboro, Oregon, United States

OHSU Knight Cancer Institute Hematology Oncology

Portland, Oregon, United States

Jefferson Health Honickman Center

Philadelphia, Pennsylvania, United States

Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

Pittsburgh, Pennsylvania, United States

The West Clinic (East Campus)

Germantown, Tennessee, United States

Nashville General Hospital at Meharry

Nashville, Tennessee, United States

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Moody Outpatient Center ? Parkland Health

Dallas, Texas, United States

Texas Oncology (Worth) - USOR

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology - Denison Cancer Center

Denison, Texas, United States

Kelsey Research Foundation

Houston, Texas, United States

Michael E Debakey VA Medical Center - NAVREF - PPDS

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Intermountain Healthcare

Murray, Utah, United States

Intermountain Cancer Center

St. George, Utah, United States

Inova Schar Cancer Institute

Falls Church, Virginia, United States

Maryview Hospital, Inc.

Newport News, Virginia, United States

Bon Secours St. Mary's Hospital

Richmond, Virginia, United States

VCU Medical Center North Hospital

Richmond, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06096779

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