跳至主要内容
临床试验/NCT07193316
NCT07193316已完成不适用

Real Life Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Efficacy and safety of Atezolizumab Bevacizumab in terms of overall survival (OS) compard to TKIs.

研究概览

简要总结

Following the results of the randomized clinical trial IMbrave150, the combination of Atezolizumab with Bevacizumab became the first line regimen for patients with advanced hepatocellular carcinoma and it was approved by the FDA and the EMA. Despite these results, real life data on safety and efficacy of this therapy are still lacking. The unmet needs currently observed are: the safety and efficacy in patients with mild liver decompensation (Child Pugh B class) detected before or during treatment start and the role of liver decompensation compared to TKIs therapy. Liver decompensation is not necessary associated with tumor progression and it may occur in patients with liver cirrhosis. Its prognostic role is not known. in this multicentric observational study the Authors enrolled patients with liver cirrhosis and advanced hepatocellular carcinoma treated with Atezolizumab/Bevacizumab to analyse efficacy, safety compared to a retrospectively collected matched cohort of patients treated with TKIs. Moreover They evaluated the safety and efficacy of Atezolizumab/Bevacizumab according to liver function (detected as Child Pugh score and Albumin-Bilirubin grade), underlying etiology of liver disease, presence or absence of portal hypertension and finally presence or absence of liver decompensation. Furthermore, the Authors evaluated its prognostic role on overall survival and time to progression.

详细描述

Following the results of the randomized clinical trial IMbrave150, the combination of Atezolizumab with Bevacizumab became the first line regimen for patients with advanced hepatocellular carcinoma and it was approved by the FDA and the EMA. Despite these results, real life data on safety and efficacy of this therapy are still lacking. The unmet needs currently observed are: the safety and efficacy in patients with mild liver decompensation (Child Pugh B class) detected before or during treatment start and the role of liver decompensation compared to TKIs therapy. Liver decompensation is not necessary associated with tumor progression and it may occur in patients with liver cirrhosis. Its prognostic role is not known. in this multicentric observational study the Authors enrolled patients with liver cirrhosis and advanced hepatocellular carcinoma treated with Atezolizumab/Bevacizumab to analyse the safety and efficacy compared to a retrospectively collected matched cohort of patients treated with TKIs. Moreover they evaluated the safety and efficacy of Atezolizumab/Bevacizumab according to liver function (detected as Child Pugh score and Albumin-Bilirubin grade), underlying etiology of liver disease, presence or absence of portal hypertension and finally presence or absence of liver decompensation. Furthermore, they evaluated its prognostic role on overall survival and time to progression.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with liver cirrhosis (Child Pugh A or Child Pugh B) and advanced HCC eligible for systemic therapy
  • radiological or histological diagnosis of HCC
  • age > 18 years old

排除标准

  • age < 18 years old
  • patients without HCC or with HCC eligible for curative or locoregional treatments

研究组 & 干预措施

patients receiving tyrosine kinase inhibitors

494 patients treated with Sorafenib or Lenvatinib per advanced HCC

干预措施: no intervention (Other)

patients receiving atezolizumab/bevacizumab

247 patients with advanced HCC that received Atezolizumab Bevacizumab

干预措施: no intervention (Other)

结局指标

主要结局

Efficacy and safety of Atezolizumab Bevacizumab in terms of overall survival (OS) compard to TKIs.

时间窗: 2 years

efficacy and safety of atezolizumab bevacizumab in terms of overall survival

次要结局

  • time under treatment(2 years)
  • time to decompensation(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ponziani Francesca Romana

Dr

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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