A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
NCT ID: NCT06096779
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-07-15
2026-11-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma
NCT04829383
Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
NCT05096715
Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
NCT06806579
Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC)
NCT04541173
An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery
NCT06117891
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A: Atezolizumab+Bevacizumab
Participants will receive Atezolizumab plus Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21-day cycle.
Cohort B: Atezolizumab
Participants will receive Atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21-day cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Treatment with locoregional therapy to liver within 28 days prior to initiation of study 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 of study treatment
* Inadequately controlled hypertension
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
* Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded.
* Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma 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 or that are at high risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
* Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
* Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
* History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B.
* Participants with ascites controlled on diuretics are allowed.
* History of spontaneous bacterial peritonitis within last 12 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Physician Group
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
Thomas Jefferson University
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: ML44719 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML44719
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.