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A Phase III Randomized, 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 Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

The following abbreviations were used in the Adverse Event section:

- international normalized ratio (inr)

- Common Terminology Criteria for Adverse Events (ctcae)

- Not Otherwise Specified (nos)

- Gastrointestinal (gi)

- Central nervous system (cns)

- Absolute Neutrophil Count (anc)

- Alanine aminotransferase (ALT)

- Aspartate aminotransferase (AST)

- Creatine phosphokinase (cpk)

- Gammaglutamyltransferase (ggt)

- Genitourinary (gu)

- Atrioventricular (av)

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 histologically or cytologically documented Hepatocellular Carcinoma

- 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 RECIST
(Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local

- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (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

- Renal failure requiring hemo- or peritoneal dialysis

- History of cardiac disease

- Active clinically serious infections

- Known history of human immunodeficiency virus (HIV) infection

- Known central nervous system 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), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Overall Survival was defined as the time from date of starting treatment 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 to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

November 2008

Related Keywords:

  • Carcinoma, Hepatocellular
  • Liver Cancer
  • Cancer
  • Carcinoma
  • Carcinoma, Hepatocellular



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