A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Tiragolumab: Tiragolumab will be administered by intravenous (IV) infusion at a fixed dose of 600 mg on Day 1 of each 21‐day cycle. Atezolizumab: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21‐day cycle. Bevacizumab: Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21‐day cycle. CONDITION: Carcinoma, Hepatocellular PRIMARY OUTCOME: efficacy; Observation and examination, RECIST v1.1 SECONDARY OUTCOME: safety, efficacy, phamacokinetics,other; Observation and examination, RECIST v1.1 INCLUSION CRITERIA: ‐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 ‐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 to av
Epistemonikos ID: 75785fcf09ed8ccab1c7af1dce6ab0237749c255
First added on: Aug 26, 2024