A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

Trial Status:

This trial runs in
  • bei-jing-shi
  • fu-zhou-shi
  • guang-zhou-shi
  • Hiroshima
  • nan-jing-shi
  • Osakasayama
  • shang-hai-shi
  • Suita
  • Xi'an
  • zheng-zhou-shi
Trial Identifier:

NCT04712643 ML42612

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are unsuitable for curative therapy.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04712643 , ML42612 Trial Identifier
      Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE) Treatments
      Hepatocellular Carcinoma Condition
      Official Title

      A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
      • Eligible for TACE treatment
      • No prior systemic therapy for HCC, especially immunotherapy
      • No prior locoregional therapy to the target lesion(s)
      • At least one measurable untreated lesion
      • ECOG Performance Status of 0-1
      • Child-Pugh class A
      Exclusion Criteria
      • Evidence of macrovascular invasion (MVI)
      • Evidence of extrahepatic spread (EHS)
      • Being a candidate for curative treatments
      • Any condition representing a contraindication to TACE as determined by the investigators
      • Active or history of autoimmune disease or immune deficiency
      • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
      • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
      • Evidence of bleeding diathesis or significant coagulopathy

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