ROLE OF CIRCULATING TUMOR CELLS (CTC) IN THE PREDICTION OF SURVIVAL AND RESPONSE TO TREATMENT IN PATIENTS WITH INTERMEDIATE AND ADVANCED HEPATOCELLULAR CARCINOMA (HCC).
Background. In different solid cancers, CTC have proved to be surrogates of tumor aggressiveness and predictors of treatment response. More exactly, CTC have shown to correlate with overall survival (OS) and response rate (RR). The evidence in the context of HCC are less strong even if some studies have produced encouraging results. End-points of the Study. Endpoints of the study are defining the possible role of CTC in the prediction of OS and RR in patients with intermediate and advanced HCC candidate to undergo TACE, sorafenib and TARE. Population and Methods. Patients of both sexes aged over 18 years with intermediate and advanced HCC candidate to TACE or sorafenib or TARE will be included in the study. Patients who undergo orthotopic liver transplantation will be excluded. A baseline and subsequent measurements of CTC concentration in peripheral venous blood before and after the treatments for HCC will be performed according to a regular schedule. ScreenCell Cyto kit will be used for the detection of CTC in peripheral blood and an immunofluorescence analysis will follow. Parameters of Efficacy. OS is the major parameter of efficacy in the present study while secondary parameter of efficacy is RR judged according to RECIST and mRECIST criteria. RR will be evaluated with contrast TC or RMN. The main object of the study is the potential role of CTC in the prediction of OS and RR.