A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
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Keep this study
Lead
Hoffmann-La Roche
The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
At least one measurable untreated lesion
ECOG Performance Status of 0 or 1
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent
For men: agreement to remain abstinent
Child-Pugh class A
You may not be if
History of leptomeningeal disease
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 scan
Known active tuberculosis
History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
Moderate or severe ascites
History of hepatic encephalopathy
Co-infection of HBV and HCV
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Prior history of hypertensive crisis or hypertensive encephalopathy
Evidence of bleeding diathesis or significant coagulopathy
History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Clareo Health | A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
