New hope for liver cancer patients with cirrhosis: safety trial launches
NCT ID NCT06096779
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This study is for people with advanced liver cancer (hepatocellular carcinoma) who also have moderate cirrhosis (Child-Pugh B7 or B8). It tests the safety of two drugs, atezolizumab and bevacizumab, given together or alone as a first treatment. The goal is to see if these drugs are safe enough to use in this specific group of patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226-1925, United States
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California Liver Research Institute
Pasadena, California, 91105-2561, United States
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Cedars Sinai Comprehensive Transplant Center
West Hollywood, California, 90048-2422, United States
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Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio, 45428-9000, United States
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George Washington University- Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
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Harbor UCLA Medical Center
Torrance, California, 90502-2006, United States
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Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Inova Schar Cancer Institute
Falls Church, Virginia, 22042, United States
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Intermountain Cancer Center
St. George, Utah, 84790, United States
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Intermountain Healthcare
Murray, Utah, 84107-5741, United States
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James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, 10468-3904, United States
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Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107, United States
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Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124-5806, United States
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Kelsey Research Foundation
Houston, Texas, 77025-1669, United States
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LSU Health Baton Rouge
Baton Rouge, Louisiana, 70805, United States
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Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
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Liver Institute at Methodist Dallas
Dallas, Texas, 75203-1260, United States
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Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas, 77030-4211, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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Moody Outpatient Center ? Parkland Health
Dallas, Texas, 75235, United States
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MorristownMedicalCenter
Morristown, New Jersey, 07962, United States
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NYU Langone Hospital - Long Island
Mineola, New York, 11501-4064, United States
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NYU Langone Medical Center
New York, New York, 10016-9451, United States
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Nashville General Hospital at Meharry
Nashville, Tennessee, 37208-2918, United States
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Northwestern University
Chicago, Illinois, 60611-2908, United States
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OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, 97239-3011, United States
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Orlando Health Inc.
Orlando, Florida, 32806, United States
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Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808-4300, United States
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Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
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Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218-1237, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
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Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, 07103, United States
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Saint Luke?s Hospital of Kansas City
Kansas City, Missouri, 64111, United States
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Stanford Health Care
Stanford, California, 94305, United States
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Texas Oncology (Worth) - USOR
Dallas, Texas, 75246-2008, United States
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Texas Oncology - Denison Cancer Center
Denison, Texas, 75020-0084, United States
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The Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637-1426, United States
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The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5020, United States
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The West Clinic (East Campus)
Germantown, Tennessee, 38138-1762, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
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University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
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University of California Davis Medical Center
Sacramento, California, 95817, United States
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University of California Irvine Medical Center
Orange, California, 92868, United States
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University of Illinois Health Outpatient Care Center
Chicago, Illinois, 60612-4795, United States
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University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536-7001, United States
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University of Southern California
Newport Beach, California, 92663, United States
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University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California, 90089-5601, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001, United States
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VCU Medical Center North Hospital
Richmond, Virginia, 23298-5028, United States
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Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
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Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240, United States
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Virginia Mason Medical Center
Seattle, Washington, 98101, United States
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Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422-0001, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells keep liver cancer at bay?
- Can a new drug boost the power of existing liver cancer therapy?
- Could a daily mineral make liver cancer therapy work better?
- Can a triple drug attack stop liver cancer from coming back?
- Can a custom vaccine train the body to fight liver cancer?
- Personalized liver cancer treatment: a quest for predictive biomarkers