Advanced or Metastatic Hepatocellular Carcinoma Clinical Trial
Official title:
Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma
To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall
survival in patients with advanced or metastatic hepatocellular carcinoma. However, this
treatment causes many adverse effects that may limit its prescription.
Under these conditions, predicting and therefore potentially preventing the adverse effects
of sorafenib is a major issue in the management of patients with hepatocellular carcinoma
treated with this drug.
Currently, there is little data available on the correlation between the pharmacokinetics of
sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.
Investigators propose an observational cohort study evaluating the correlation between
residual plasma concentration of sorafenib and the risk of severe adverse effects (grades
3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.
This study should include 60 patients over an expected duration of 12 months. The aim of this
work is to determine whether there is a correlation between the residual plasma concentration
of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in
patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of
the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to
anticipate and thus prevent these adverse effects in order to increase the safety of the drug
and potentially its effectiveness.
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