Residual Plasma Concentration of Sorafenib and Adverse Events in CHC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced or Metastatic Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

Facility Contacts

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Dupont Benoit, MD, PhD

Role: primary

Other Identifiers

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16-109

Identifier Type: -

Identifier Source: org_study_id