Advanced or Metastatic Hepatocellular Carcinoma Clinical Trial
— PharmacoCHCOfficial title:
Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma
| Verified date | November 2017 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | March 2019 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Major Patients. - Patients with hepatocellular carcinoma on cirrhosis. - Patients treated for the first time with sorafenib for hepatocellular carcinoma. - Informed information about the study. Exclusion Criteria: - Patients with contraindications to sorafenib. - Pregnant or lactating woman |
| Country | Name | City | State |
|---|---|---|---|
| France | Caen University Hospital | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | residual plasma concentration of sorafenib | from baseline over 6 month | ||
| Primary | occurrence of severe adverse effects (grades 3-5) | from baseline over 6 month |