NCT03340636

Residual Plasma Concentration of Sorafenib and Adverse Events in CHC

Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced or Metastatic Hepatocellular Carcinoma

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2017-11-13
• Last updated: 2017-11-13

Locations

1 site across 1 country: France