A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: multikinase inhibitor; Sorafenib 400 mg (orally) twice daily; Matching placebo (orally) twice daily
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is

        -  Find out if patients receiving Sorafenib will live longer

        -  Find out if Sorafenib has any effect on patient reported outcomes

        -  Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their
           metastases

        -  Determine the pharmacokinetics (PK) in patients with liver cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages eligible for study: 18 years and above, Genders eligible for study: both

          -  Patients who have a life expectancy of at least 12 weeks

          -  Patients with advanced Hepatocellular carcinoma (HCC) (unresectable, and/or
             metastatic) which has been histologically or cytologically documented

          -  Patients must have at least one tumor lesion that meets both of the following criteria

               1. Accurately measured in at least one dimension according to Response Evaluation
                  Criteria in Solid Tumors (RECIST)

               2. Not been previously treated with local therapy

          -  Patients who have received local therapy, such as surgery, radiation therapy, hepatic
             arterial embolization, chemoembolization, radiofrequency ablation, percutaneous
             ethanol injection or cryoablation are eligible. Previously treated lesions will not be
             selected as target lesions. Local therapy must be completed at least 4 weeks prior to
             the baseline scan

          -  Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status of
             0, 1, or 2

        Exclusion Criteria:

          -  Previous or concurrent cancer that is distinct in primary site or histology from HCC,
             EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
             tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]&T1
             [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3
             years prior to entry is permitted

          -  History of cardiac disease

          -  Active clinically serious infections

          -  Known history of human immunodeficiency virus (HIV) infection

          -  Known central nervous system (CNS) tumors including metastatic brain disease

          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to
             study entry