Hepatocellular CarcinomaPhase 2KirrosNCT06096779
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Genentech, Inc. at 54 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Atezolizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 54 sitesin 2 countries
- Study dates
- 15 Jul 2024to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (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 10^9 per liter (/L) (≥1000 per microliter [/μL]) without granulocyte colony-stimulating factor support
- Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
- Hemoglobin ≥ 80 grams per liter (g/L) (8 grams per deciliter [g/dL]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)
- Serum bilirubin ≤ 3 × ULN
- Creatinine clearance ≥ 50 milliliters per minute (mL/min) (calculated using the Cockcroft-gault formula)
- Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
- International normalized ratio (INR) ≤2.3
General Exclusion Criteria:
- Pregnancy or breastfeeding
- Prior treatment with cluster of differentiation 137 (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
- Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.
- Participants with ascites controlled on diuretics are allowed
- History of spontaneous bacterial peritonitis within last 12 months
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States53 sites
LSU Health Baton Rouge
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808-4300
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Levine Cancer Institute
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611-2908
University of Illinois Health Outpatient Care Center
Chicago, Illinois, 60612-4795
The Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637-1426
Liver Institute at Methodist Dallas
Dallas, Texas, 75203-1260
Moody Outpatient Center ? Parkland Health
Dallas, Texas, 75235
Texas Oncology (Worth) - USOR
Dallas, Texas, 75246-2008
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001
Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio, 45428-9000
Texas Oncology - Denison Cancer Center
Denison, Texas, 75020-0084
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Inova Schar Cancer Institute
Falls Church, Virginia, 22042
The West Clinic (East Campus)
Germantown, Tennessee, 38138-1762
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124-5806
Kelsey Research Foundation
Houston, Texas, 77025-1669
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas, 77030-4211
Saint Luke?s Hospital of Kansas City
Kansas City, Missouri, 64111
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536-7001
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California, 90089-5601
NYU Langone Hospital - Long Island
Mineola, New York, 11501-4064
Intermountain Healthcare
Murray, Utah, 84107-5741
Nashville General Hospital at Meharry
Nashville, Tennessee, 37208-2918
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, 07103
University of Southern California
Newport Beach, California, 92663
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5020
University of California Irvine Medical Center
Orange, California, 92868
Orlando Health Inc.
Orlando, Florida, 32806
California Liver Research Institute
Pasadena, California, 91105-2561
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, 97239-3011
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226-1925
VCU Medical Center North Hospital
Richmond, Virginia, 23298-5028
University of California Davis Medical Center
Sacramento, California, 95817
Virginia Mason Medical Center
Seattle, Washington, 98101
Intermountain Cancer Center
St. George, Utah, 84790
Stanford Health Care
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, 10468-3904
Harbor UCLA Medical Center
Torrance, California, 90502-2006
University of Arizona Cancer Center
Tucson, Arizona, 85724
George Washington University- Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422-0001
Cedars Sinai Comprehensive Transplant Center
West Hollywood, California, 90048-2422
Puerto Rico1 site
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
About this study
Official title: A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
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.
Read the detailed description
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Atezolizumab, Bevacizumab
- Keywords
- Cirrhosis, Liver Cancer, Liver Tumor, Child-pugh B, Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Immune Checkpoint Inhibitor, Digestive System Neoplasms, Kirros, ML44719, Liver Disease, Genentech, Immunotherapy, CPB, CPB 7, CPB 8, Tecentriq, Avastin, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis, Liver Neoplasms, Digestive System Neoplasms, Liver Diseases, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq; RO5541267
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
BevacizumabDrug
Also called Avastin; RO4876646
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Atezolizumab+Bevacizumab | Experimental | Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator. Receives: Drug: Atezolizumab; Drug: Bevacizumab |
| Cohort B: Atezolizumab | Experimental | Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) in Cohorts A and B.
Measured: Baseline through the end of the study (up to approximately 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096779
- Sponsor's protocol ID
- ML44719
- Acronym
- Kirros
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
- ClinicalTrials.gov ID
- NCT06096779
- Acronym / sponsor ID
- Kirros / ML44719
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Cirrhosis, Liver Cancer, Liver Tumor, Child-pugh B, Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Immune Checkpoint Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Atezolizumab+Bevacizumab | Experimental | Drug: Atezolizumab, Drug: BevacizumabParticipants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator. |
| Cohort B: Atezolizumab | Experimental | Drug: AtezolizumabParticipants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: Tecentriq; RO5541267Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle. | Drug | Cohort A: Atezolizumab+Bevacizumab, Cohort B: Atezolizumab |
| BevacizumabAlso: Avastin; RO4876646Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle. | Drug | Cohort A: Atezolizumab+Bevacizumab |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline through the end of the study (up to approximately 36 months)
An AE is any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) in Cohorts A and B.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Genentech, Inc. at 54 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Baseline through the end of the study (up to approximately 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.