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DEFINERx050: A Multicentre, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab (Anti-VEGF Antibody) as Neo-Adjuvant ImmunoTherapy Versus Active Surveillance in Hepatocellular Carcinoma Patients with high Onco-Fetal Characteristics Before Surgical Resection

ACTRN 12624001345572

Brief Summary

This study will investigate the effect Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab (Anti-VEGF Antibody) Immunotherapy Before Surgical Resection Versus Surgical Resection alone in Hepatocellular Carcinoma Patients.

Intervention/Treatment

  • Drug: Atezolizumab (Tecentriq).
  • Drug: Bevacizumab (Avastin).
  • Surgical resection.
  • Active surveillance.

Inclusion Criteria

  • Signed Informed Consent Form.
  • Age greater than or equal to 18 years.
  • Ability to comply with the study protocol.
  • First diagnosis of HCC and MDT recommendation of curative resection.
  • Absence of major macrovascular invasion.
  • Absence of extrahepatic spread.
  • AST and ALT less that or equal to 5 × upper limit of normal (ULN) and total bilirubin less than or equal to 51 µmol/L.
  • Baseline FFPE tumour tissue biopsy.
  • Documented virology status of hepatitis B and C.
  • ECOG Performance Status of 0 or 1.
  • Child-Pugh Class A status or up to B7.
  • Adequate hematologic and end-organ function.

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