title: Personalized Clinical Trials in Hepatocellular Carcinoma Based on Biomarker Selection.
abstract: BACKGROUND
  Since the approval of sorafenib there have been numerous failures of new agents in Phase III studies for treatment of advanced hepatocellular carcinoma (HCC). These studies have generally ignored the molecular heterogeneity of HCC and they have not enrolled patients based on predictive markers of response. The development of molecular targeted therapeutics in HCC needs to model the approach that has been taken with great success in other solid tumors, to decrease the likelihood of failure in future studies.
  
  
  CONCLUSIONS
  Here we review the paradigm taken with novel targeted agents in other solid tumors and highlight ongoing studies in HCC that are incorporating biomarkers in clinical development.
  
  
  CONCLUSIONS
  With the appreciation of the molecular diversity of HCC, clinical development of new agents in HCC will need to be targeted towards those patients who are most likely to benefit. This strategy, based on biomarkers for patient selection, is more likely to yield positive results and mitigate the risk of continued negative Phase III studies.
authors: Division of Hematology Oncology Geffen School of Medicine at UCLA, Los Angeles, Calif., USA.
authors: Bingnan
authors: B
authors: Zhang
authors: Division of Hematology Oncology Geffen School of Medicine at UCLA, Los Angeles, Calif., USA.
authors: Richard S
authors: RS
authors: Finn
keywords: Biomarkers; HCC; Liver cancer; Molecular therapy; Tivantinib