Hepatocellular carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : Atezolizumab
INN of investigational material : Atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
F. Hoffmann-La Roche, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) - No prior systemic therapy for HCC - 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
Exclusion criteria
Exclusion criteria: - 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 - 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 - Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding - Moderate or severe ascites - History of hepatic encephalopathy - Co-infection of HBV and HCV - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - Treatment with systemic immunostimulatory agents - Inadequately controlled arterial hypertension - 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 - Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Observation, RECIST ver1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics other Observation, RECIST ver1.1, modified RECIST | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed