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Clinical Trials List

Protocol NumberCO44668
NCT Number(ClinicalTrials.gov Identfier)NCT05904886
Active

2023-09-01 - 2027-12-31

Phase III

Recruiting5

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

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Long-Bin Jeng Division of Others -
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shi-Ming Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Hepatocellular

Objectives

This is a phase 3, randomized, multicenter, double-blind, placebo-controlled trial in patients with unresectable, locally advanced, or metastatic HCC who have not previously received systemic therapy in this setting. Among participants, the efficacy and safety of atezolizumab + bevacizumab + tiragolumab compared with atezolizumab + bevacizumab was evaluated.

Test Drug

AtezolizumabBevacizumabTiragolumab

Active Ingredient

Atezolizumab
Bevacizumab
Tiragolumab

Dosage Form

IV
IV
IV

Dosage

1200mg/20ml
400mg/16ml
600mg/10ml

Endpoints

‧ To evaluate the efficacy of atezolizumab + bevacizumab + tiragolumab compared with atezolizumab + bevacizumab

Inclution Criteria

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 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.

Exclusion Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    650 participants

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