A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

Status: Recruiting
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (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 locally advanced 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 study treatment

• Adequate hematologic and end-organ function

• Life expectancy of at least 12 weeks

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

• Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocyte colony-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

Locations
United States
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
University of Southern California-Keck School of Medicine -1975 Zonal Ave
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Newport Beach
University of California Irvine Medical Center
COMPLETED
Orange
California Liver Research Institute
RECRUITING
Pasadena
University of California Davis Medical Center
COMPLETED
Sacramento
Stanford Health Care
RECRUITING
Stanford
Harbor UCLA Medical Center
RECRUITING
Torrance
Cedars Sinai Comprehensive Transplant Center
RECRUITING
West Hollywood
Colorado
Rocky Mountain Cancer Centers (Williams) - USOR
RECRUITING
Denver
Connecticut
Hartford Healthcare Cancer Institute at Hartford Hospital
RECRUITING
Hartford
Washington, D.c.
Washington DC VA Medical Center
RECRUITING
Washington D.c.
Florida
Orlando Health Inc.
RECRUITING
Orlando
Illinois
Northwestern University
RECRUITING
Chicago
The Duchossois Center for Advanced Medicine
RECRUITING
Chicago
University of Illinois Health Outpatient Care Center
RECRUITING
Chicago
Kentucky
University of Kentucky - Markey Cancer Center
RECRUITING
Lexington
Louisiana
LSU Health Baton Rouge
RECRUITING
Baton Rouge
Our Lady of the Lake Physician Group
RECRUITING
Baton Rouge
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Michigan
Veterans Affairs Ann Arbor Healthcare System
RECRUITING
Ann Arbor
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Henry Ford Health System
RECRUITING
Detroit
Missouri
Saint Luke?s Hospital of Kansas City
RECRUITING
Kansas City
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
New Jersey
MorristownMedicalCenter
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Rutgers Cancer Institute of New Jersey at University Hospital
RECRUITING
Newark
New York
Long Island Heart Associates
RECRUITING
Mineola
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
RECRUITING
New Hyde Park
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
James J Peters Veterans Administration Medical Center - NAVREF
RECRUITING
The Bronx
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University Hospitals Cleveland Medical Center
WITHDRAWN
Cleveland
Dayton VA Medical Center - NAVREF - PPDS
RECRUITING
Dayton
Oklahoma
The University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Kaiser Permanente Westside Medical Center
RECRUITING
Hillsboro
OHSU Knight Cancer Institute Hematology Oncology
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
COMPLETED
Pittsburgh
Tennessee
The West Clinic (East Campus)
RECRUITING
Germantown
Nashville General Hospital at Meharry
RECRUITING
Nashville
Texas
Liver Institute at Methodist Dallas
RECRUITING
Dallas
Moody Outpatient Center ? Parkland Health
RECRUITING
Dallas
Texas Oncology (Worth) - USOR
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Oncology - Denison Cancer Center
RECRUITING
Denison
Houston Methodist Hospital
RECRUITING
Houston
Kelsey Research Foundation
RECRUITING
Houston
Michael E Debakey VA Medical Center - NAVREF - PPDS
RECRUITING
Houston
Utah
Intermountain Healthcare
RECRUITING
Murray
Intermountain Cancer Center
RECRUITING
St. George
Virginia
Inova Schar Cancer Institute
COMPLETED
Falls Church
Maryview Hospital, Inc.
WITHDRAWN
Newport News
Bon Secours St. Mary's Hospital
RECRUITING
Richmond
VCU Medical Center North Hospital
RECRUITING
Richmond
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Other Locations
Puerto Rico
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Contact Information
Primary
Reference Study ID Number: ML44719 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2026-11-16
Participants
Target number of participants: 30
Treatments
Experimental: Cohort A: Atezolizumab+Bevacizumab
Participants will receive Atezolizumab plus Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Experimental: Cohort B: Atezolizumab
Participants will receive Atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov