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A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 3
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Outcome Time Frame:

From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Taiwan: National Bureau of Controlled Drugs

Study ID:




Start Date:

October 2005

Completion Date:

July 2009

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular