Global Assessment of Predictive Biomarkers in Malian BCLC Stage C Hepatocellular Carcinoma Patients under Mono or Combination Immune Checkpoint Inhibitors Treatment: A Proposed Research Protocol

Abstract

Background: According to the Barcelona Clinic Liver Cancer (BCLC) staging system, only the advanced stage (stage C) hepatocellular carcinoma (HCC) patient is eligible for systemic treatments. In addition to sorafenib and lenvatinib that represent the standard-of-care options in the first-line treatment, the multikinase inhibitors regorafenib and cabozantinib or ramucirumab, the anti-vascular-endothelial growth factor-2 (VEGF-R2) in the second-line setting but their poor tolerability have brought out the need for new therapeutic strategies, the immune checkpoint inhibitors (ICIs) might represent the most important novelty and the future perspective also in the field of HCC. Therefore, the need to identify predictive biomarkers to select those patients who might actually benefit from ICIs-based treatment is urgently a challenge. Our central hypothesis is that the global assessment of predictive biomarkers could help patient-specific choices for ICIs treatment by developing simplified therapeutic algorithms and novel prognostic index for efficient HCC management. The primary aim of this work will be to globally assess predictive biomarkers in Malian patients with BCLC stage C HCC undergoing treatment with ICIs in mono or in combination.