PACTR202402574273311尚未招募3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Roche
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •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 participants
- •Disease that is not amenable to curative surgical and/or locoregional therapies
- •No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC
- •Measurable disease according to RECIST v1.1
- •ECOG Performance Status of 0 or 1 within 7 days prior to randomization
- •Child-Pugh Class A within 7 days prior to randomization
- •Adequate hematologic and end-organ function
- •Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
- •Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.
排除标准
- •Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
- •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
- •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
- •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
- •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
- •Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
- •Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
- •Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
研究者
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