CTIS2023-503422-39-00招募中1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with and without Tiragolumab, In Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma - CO44668
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 659
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
- 18 至 65+（—）
- 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, No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC, Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Eastern Cooperative Oncology Group (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, Negative human immunodeficiency virus (HIV) test at screening, Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV), Agreement to use protocol defined methods of contraception by both male and female participants
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or 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, Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC, Co-infection with HBV and HCV, Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening, Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti- TIGIT therapeutic antibodies, 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 within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding, Active tuberculosis (TB), as documented by a positive purified protein derivative (PPD) skin test or TB blood test and confirmed by a positive chest X-ray or chest CT scan within 3 months prior to initiation of study treatment, History of malignancy other than HCC within 5 years prior to screening, Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina, History of hypertensive crisis or hypertensive encephalopathy
研究者
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