Trial Details

A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

NCT06096779

RECRUITING

DESCRIPTION

The purpose of this study is to assess the safety and efficacy 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.

CONDITIONS

ELIGIBILITY CRITERIA

• 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 patients
• 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 General
• Exclusion Criteria
• :
• Pregnancy or breastfeeding
• 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
• Patients 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.
• 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
• 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
• History of hepatic encephalopathy requiring hospitalization or treatment escalation within 6 months prior to study treatment, or any continued symptoms of encephalopathy despite medical management
• History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS)
• History of ascites requiring therapeutic paracentesis over the last 3 months
• History of spontaneous bacterial peritonitis within last 12 months