hepatocellular carcinoma patients undergoing transarterial chemoembolisation (TACE)
Conditions
Interventions
Trade Name: Nexavar
Product Name: sorafenib
Pharmaceutical Form: Tablet
Sponsors
Medizinische Universität Wien Univ. Klinik f. Innere Med. III, Abt. f. Gastroenterologie/Hepatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1 Inclusion criteria -Patients with histologically confirmed HCC not suitable for OLT or resection (>3 nodules, >5 cm diameter, vascular invasion, clinically significant portal hypertension, other contraindications against OLT) -Child-Pugh Stage A or B -Liver disease of any etiology -Written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures -Patient must be able to comply with the protocol -Age =18 years -Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the Sorafenib. Fertile women and men of childbearing potential ( 1 x 109/L Platelet count > 40 x 109/L Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time ? 40% -Biochemistry: Total bilirubin ? 5 mg/dL Serum creatinine 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: -extrahepatic tumor spread -complete portal vein thrombosis (common trunk) -Child-Pugh-Stage C -Prior TACE or TAE -Other experimental therapies for HCC -Acute variceal bleeding within the last 2 weeks -Large oesophageal varices (>5 mm diameter) without prophylactic band ligation -Past or current history (within the last 2 years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix -History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke within 325mg/day) -Pregnancy (positive serum pregnancy test) or lactation -Uncontrolled hypertension -Serious, non-healing wound, ulcer, or bone fracture -Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study -Clinically significant (i.e. active) cardiovascular disease for example cerebravascular accidents (= 6 months prior to study entry), myocardial infarction (= 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication -Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of Sorafenib plus TACE in HCC Patients;Secondary Objective: • to evaluate portal hypertension and systemic hemodynamics • to evaluate liver stiffness as measured by Fibroscan • to evaluate proteomic changes in surrounding tissue • to evaluate mechanisms of Sorafenib resistance in tumor tissue • to evaluate DNA methylation of tumor genes in serum as marker of treatment response • to detect early response to Sorafenib and its possible impact on overall treatment response • to evaluate other markers treatment resistance and treatment response • Time to progression • Overall survival ;Primary end point(s): Safety of Sorafenib plus TACE 12 weeks after the last TACE. | — |
Countries
Austria
Outcome results
None listed