Neoadjuvant Atezolizumab and Adjuvant Atezolizumab + Bevacizumab in Combination With Percutaneous Radiofrequency Ablation of Small HCC: a Multicenter Randomized Phase II Trial
Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC. In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant/neoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC. Local ablation of HCC is therefore an ideal setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.
• Male or female patients ≥ 18 years of age
• Diagnostic of HCC based on Imaging (EASL guidelines)
• Patients with HCC eligible for ablation as assessed by multidisciplinary board:
‣ All HCC nodules \<3cm
⁃ 1-3 nodules of HCC
• At least one uni-dimensional measurable lesion by magnetic resonance imaging (MRI) according to modified RECIST criteria
• Liver function status Child-Pugh Class A
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
‣ Hemoglobin \> 8.5 g/dL
⁃ Absolute neutrophil count ≥ 1500/mm3
⁃ Platelet count ≥ 50,000/ mm3
⁃ Total bilirubin ≤ 2 mg/dL (ou ≤ 34 µmol/ L).
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)
⁃ Serum creatinine ≤ 1.5 x ULN
⁃ Lipase ≤ 2 x ULN
⁃ Prothrombin time \> 50%
⁃ Glomerular Filtration Rate (GFR) ≥ 35 mL/min/1.73 m2
• Life expectancy ≥ 3 months
• Women of childbearing potential and men must agree to use adequate contraception
⁃ Patients affiliated to a Social Security System