癌研連線CancerLink
進行中（不再收案） NCT05904886

評估Atezolizumab及Bevacizumab聯合或不聯合Tiragolumab用於未經治療的局部晚期或轉移性肝細胞癌（HCC）參與者的研究（IMbrave152）

肝癌食道癌膽道癌肉瘤Phase IIIIII 期IV 期

本研究旨在評估tiragolumab（一種抗TIGIT單克隆抗體）聯合atezolizumab及bevacizumab作為第一線治療，在不可切除、局部晚期或轉移性HCC參與者中的療效及安全性。 根據修訂版本5，在申辦方發出備忘錄後，接受atezolizumab加bevacizumab加tiragolumab組治療的參與者建議停

適應症：Hepatocellular Carcinoma

收案條件

納入條件

  • 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
  • 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
  • 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.

排除條件

  • 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 cluster of differentiation 137 (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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。