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).
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: 800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. [twice daily], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead; 4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sorafenib; TACE; DC bead; Combination

Summary:

      This study will look at whether our drug (sorafenib) in combination with chemotherapy
      delivered directly into your tumor using beads (DC Bead) will slow the progression of the
      disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing
      the adverse effects that normally occur with chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

        Exclusion Criteria:

          -  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.