Clinical Research Details
Title:
An International, Non-interventional Study of Sorafenib to Evaluate the Safety in Patients With Unresectable Hepatocellular Carcinoma
Purpose:
The primary objective of this international, non-interventional surveillance study is to evaluate the safety of sorafenib in all patients with unresectable hepatocellular carcinoma who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made under real-life practice conditions and in a variety of patient subsets regionally and globally.
Study Number:
202118
Number of Patients:
3000
Elgibility:
Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable hepatocellular carcinoma who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. Radiographic diagnosis needs typical findings of hepatocellular carcinoma by radiographic method, i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP)
or MRI.
Other specific inclusion and exclusion criteria are available from the Loyola Clinical Trials Office, (708) 216-2027.
Treatment:
There are no additional study-specific tests performed while enrolled in this registry study; however, your study doctor may capture results of testing performed for your usual clinical care for the registry.
During your treatment, your physician will fill out study forms at regular intervals. Your doctor must list some information concerning the course of your disease while being treated and (if applicable) any medical condition.
You will provide information about your liver cancer to your study doctor. Your information will be collected at the enrollment visit and approximately every six to 12 weeks after that and will include information on safety and detailed clinical/health status. Information collected will include demographics (e.g., gender, race, date of birth), condition of your disease, family medical history, history of previous treatments, current medications and clinical follow-up.
Principal Investigator:
Enrollment Phone:
(708) 216-2027