A phase III study of atezolizumab in patients with hepatocellular carcinoma
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-jRCT2080223820
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
The safety profile of the combination treatment regimen of Atezolizumab plus Bevacizumab was consistent with the known safety profiles of each individual study drugs and the underlying disease. A clinically meaningful improvement in both OS and PFS based on IRF-assessment was observed with Atezolizumab plus Bevacizumab over Sorafenib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 501
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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Observation, RECIST ver1.1
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>other<br>Observation, RECIST ver1.1, modified RECIST