Actively Recruiting
A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
Led by Genentech, Inc. · Updated on 2026-06-01
30
Participants Needed
61
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of atezolizumab alone or combined with bevacizumab as first-line treatments for participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis. This Phase II, open-label study focuses on patients who have not received previous systemic therapy in this setting and aims to assess treatment safety in this specific population. Participants are assigned to one of two groups: Cohort A receives atezolizumab plus bevacizumab, and Cohort B receives atezolizumab alone. Both drugs are given by intravenous infusion every 21 days, with atezolizumab dosed at 1200 mg and bevacizumab at 15 mg/kg. Treatment continues until unacceptable side effects or loss of clinical benefit occur, as determined by the investigator. During the study, participants undergo regular assessments to monitor safety and treatment effects, including tracking adverse events from the start of treatment up to about 36 months. Evaluations include clinical exams, laboratory tests, and imaging to measure disease status. The study also monitors liver function and overall health, with follow-up visits to ensure participant safety throughout the trial period.
CONDITIONS
Brief Title
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by histology, cytology, or AASLD clinical criteria
- Disease not suitable for curative surgery or locoregional therapies
- No prior systemic treatment for advanced or unresectable HCC
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0 to 2 within 7 days before treatment
- Child-Pugh B7 or B8 cirrhosis at screening and within 7 days before treatment
- Adequate blood counts and organ function
- Life expectancy of at least 12 weeks
- Female participants of childbearing potential must agree to avoid pregnancy and egg donation
- Absolute neutrophil count ≥ 1.0 x 10^9/L without growth factor support
- Platelet count ≥ 50,000/µL without transfusion
- Hemoglobin ≥ 8 g/dL
- AST and ALT ≤ 5 times upper limit of normal
- Serum bilirubin ≤ 3 times upper limit of normal
- Creatinine clearance ≥ 50 mL/min
- Serum albumin ≥ 20 g/L without recent transfusion
- INR ≤ 2.3
You will not qualify if you...
- Pregnancy or breastfeeding
- Prior treatment with CD137 agonists or immune checkpoint inhibitors
- Investigational therapy within 28 days before study treatment
- Locoregional liver therapy within 28 days before treatment or unresolved side effects
- Use of systemic immunostimulatory or immunosuppressive medications
- Live vaccine within 4 weeks before treatment
- Uncontrolled high blood pressure
- Active or history of autoimmune disease or immune deficiency
- History or signs of lung inflammation or pneumonitis
- Concurrent progressing malignancy requiring treatment
- Known fibrolamellar, sarcomatoid, rare HCC variants, or mixed cholangiocarcinoma and HCC
- Untreated or progressing brain metastases
- Prior stem cell or organ transplant
- Listed for liver transplantation
- Co-infection with hepatitis B and C viruses
- Untreated or high-risk esophageal or gastric varices
- Recent significant bleeding events
- Active hepatic encephalopathy symptoms
- Planned or prior TIPS placement (excluded in Cohort A)
- Recent spontaneous bacterial peritonitis
- Other conditions as determined by investigators that may interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until unacceptable toxicity or loss of clinical benefit
Participants receive intravenous infusions of atezolizumab with or without bevacizumab every 21 days until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Infusions on Day 1 of each 21-day cycle
Trial Site Locations
Total: 61 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California, United States, 90089-5601
Actively Recruiting
4
University of Southern California
Newport Beach, California, United States, 92663
Actively Recruiting
5
University of California Irvine Medical Center
Orange, California, United States, 92868
Completed
6
California Liver Research Institute
Pasadena, California, United States, 91105-2561
Actively Recruiting
7
University of California Davis Medical Center
Sacramento, California, United States, 95817
Completed
8
Stanford Health Care
Stanford, California, United States, 94305
Actively Recruiting
9
Harbor UCLA Medical Center
Torrance, California, United States, 90502-2006
Actively Recruiting
10
Cedars Sinai Comprehensive Transplant Center
West Hollywood, California, United States, 90048-2422
Actively Recruiting
11
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, United States, 80218-1237
Actively Recruiting
12
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
13
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20422-0001
Actively Recruiting
14
Orlando Health Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
15
Northwestern University
Chicago, Illinois, United States, 60611-2908
Actively Recruiting
16
University of Illinois Health Outpatient Care Center
Chicago, Illinois, United States, 60612-4795
Actively Recruiting
17
The Duchossois Center for Advanced Medicine
Chicago, Illinois, United States, 60637-1426
Actively Recruiting
18
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States, 40536-7001
Actively Recruiting
19
LSU Health Baton Rouge
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
20
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States, 70808-4300
Actively Recruiting
21
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
22
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
23
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
24
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
25
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
26
Saint Luke?s Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
27
MorristownMedicalCenter
Morristown, New Jersey, United States, 07962
Actively Recruiting
28
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
29
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, United States, 07103
Actively Recruiting
30
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501-4064
Actively Recruiting
31
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
New Hyde Park, New York, United States, 11042-1118
Withdrawn
32
NYU Langone Medical Center
New York, New York, United States, 10016-9451
Actively Recruiting
33
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
34
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
35
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, United States, 10468-3904
Actively Recruiting
36
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
37
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Withdrawn
38
Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio, United States, 45428-9000
Actively Recruiting
39
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104-5020
Actively Recruiting
40
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, United States, 97124-5806
Actively Recruiting
41
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, United States, 97239-3011
Actively Recruiting
42
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
43
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania, United States, 15240
Completed
44
The West Clinic (East Campus)
Germantown, Tennessee, United States, 38138-1762
Active, Not Recruiting
45
Nashville General Hospital at Meharry
Nashville, Tennessee, United States, 37208-2918
Actively Recruiting
46
Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203-1260
Actively Recruiting
47
Moody Outpatient Center ? Parkland Health
Dallas, Texas, United States, 75235
Actively Recruiting
48
Texas Oncology (Worth) - USOR
Dallas, Texas, United States, 75246-2008
Actively Recruiting
49
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-0001
Actively Recruiting
50
Texas Oncology - Denison Cancer Center
Denison, Texas, United States, 75020-0084
Actively Recruiting
51
Kelsey Research Foundation
Houston, Texas, United States, 77025-1669
Actively Recruiting
52
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas, United States, 77030-4211
Actively Recruiting
53
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
54
Intermountain Healthcare
Murray, Utah, United States, 84107-5741
Actively Recruiting
55
Intermountain Cancer Center
St. George, Utah, United States, 84790
Actively Recruiting
56
Inova Schar Cancer Institute
Falls Church, Virginia, United States, 22042
Completed
57
Maryview Hospital, Inc.
Newport News, Virginia, United States, 23602
Withdrawn
58
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States, 23226-1925
Actively Recruiting
59
VCU Medical Center North Hospital
Richmond, Virginia, United States, 23298-5028
Actively Recruiting
60
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
61
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
R
Reference Study ID Number: ML44719 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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