Carcinoma, Hepatocellular Clinical Trial
— GIDEONOfficial title:
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
Status | Completed |
Enrollment | 3371 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI. - Patients must have signed an informed consent form - Patients must have a life expectancy of at least 8 weeks Exclusion Criteria: - Exclusion criteria must follow the approved local product information |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States, Uruguay, Venezuela, Vietnam, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Libyan Arab Jamahiriya, Malaysia, Mexico, Norway, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Singapore, Slovakia, Spain, Sweden, Syrian Arab Republic, Thailand, Ukraine, United Arab Emirates,
Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions | at each follow-up visit, every 2-4 months on average | Yes | |
Secondary | Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar | at every visit, roughly every 2-4 months | No | |
Secondary | The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables | at every visit, roughly every 2-4 months | No | |
Secondary | To evaluate the methods of patient evaluation, diagnosis and follow up | at every visit, roughly every 2-4 months | No | |
Secondary | To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome | at every visit, roughly every 2-4 months | No | |
Secondary | To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions | at every visit, roughly every 2-4 months | No | |
Secondary | Reports of adverse events | at every visit, roughly every 2-4 months | Yes |
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