JPRN-jRCT2080223820已完成3 期
A phase III, open-label, randomized study of atezolizumab in combination with bevacizumab compared with sorafenib in patients with untreated locally advanced or metastatic hepatocellular carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 501
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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)
研究者
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