Clareo Health | A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
Confirmed Diagnosis of HCC:
Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria
HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography \[CT\] scan, Magnetic resonance imaging \[MRI\], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
Non-cirrhotic subjects:
For subjects without cirrhosis, histological or cytological confirmation is mandatory
Documentation of original biopsy for diagnosis is acceptable
Child Pugh class A without ascites
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
You may not be if
Patients on a liver transplantation list or with advanced liver disease as defined below:
Child Pugh B and C
Active gastrointestinal bleeding
Encephalopathy
Ascites
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
