New hope for liver cancer patients with cirrhosis: safety trial launches

NCT ID NCT06096779

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Digestive System Neoplasms fatty liver disease Fibrosis hepatocellular carcinoma liver disorder Liver Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226-1925, United States

  • California Liver Research Institute

    Pasadena, California, 91105-2561, United States

  • Cedars Sinai Comprehensive Transplant Center

    West Hollywood, California, 90048-2422, United States

  • Dayton VA Medical Center - NAVREF - PPDS

    Dayton, Ohio, 45428-9000, United States

  • George Washington University- Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

  • Harbor UCLA Medical Center

    Torrance, California, 90502-2006, United States

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Schar Cancer Institute

    Falls Church, Virginia, 22042, United States

  • Intermountain Cancer Center

    St. George, Utah, 84790, United States

  • Intermountain Healthcare

    Murray, Utah, 84107-5741, United States

  • James J Peters Veterans Administration Medical Center - NAVREF

    The Bronx, New York, 10468-3904, United States

  • Jefferson Health Honickman Center

    Philadelphia, Pennsylvania, 19107, United States

  • Kaiser Permanente Westside Medical Center

    Hillsboro, Oregon, 97124-5806, United States

  • Kelsey Research Foundation

    Houston, Texas, 77025-1669, United States

  • LSU Health Baton Rouge

    Baton Rouge, Louisiana, 70805, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75203-1260, United States

  • Michael E Debakey VA Medical Center - NAVREF - PPDS

    Houston, Texas, 77030-4211, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Moody Outpatient Center ? Parkland Health

    Dallas, Texas, 75235, United States

  • MorristownMedicalCenter

    Morristown, New Jersey, 07962, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501-4064, United States

  • NYU Langone Medical Center

    New York, New York, 10016-9451, United States

  • Nashville General Hospital at Meharry

    Nashville, Tennessee, 37208-2918, United States

  • Northwestern University

    Chicago, Illinois, 60611-2908, United States

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland, Oregon, 97239-3011, United States

  • Orlando Health Inc.

    Orlando, Florida, 32806, United States

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808-4300, United States

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935, Puerto Rico

  • Rocky Mountain Cancer Centers (Williams) - USOR

    Denver, Colorado, 80218-1237, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Rutgers Cancer Institute of New Jersey at University Hospital

    Newark, New Jersey, 07103, United States

  • Saint Luke?s Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Stanford Health Care

    Stanford, California, 94305, United States

  • Texas Oncology (Worth) - USOR

    Dallas, Texas, 75246-2008, United States

  • Texas Oncology - Denison Cancer Center

    Denison, Texas, 75020-0084, United States

  • The Duchossois Center for Advanced Medicine

    Chicago, Illinois, 60637-1426, United States

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-5020, United States

  • The West Clinic (East Campus)

    Germantown, Tennessee, 38138-1762, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California Irvine Medical Center

    Orange, California, 92868, United States

  • University of Illinois Health Outpatient Care Center

    Chicago, Illinois, 60612-4795, United States

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536-7001, United States

  • University of Southern California

    Newport Beach, California, 92663, United States

  • University of Southern California-Keck School of Medicine -1975 Zonal Ave

    Los Angeles, California, 90089-5601, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-0001, United States

  • VCU Medical Center North Hospital

    Richmond, Virginia, 23298-5028, United States

  • Veterans Affairs Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105, United States

  • Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

    Pittsburgh, Pennsylvania, 15240, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington DC VA Medical Center

    Washington D.C., District of Columbia, 20422-0001, United States

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