A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overPharmaceutical / Industry100554
2004-001773-26, NCT00105443

Trial Description


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 of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Further Study Information

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)

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 histologically or cytologically documented Hepatocellular Carcinoma (HCC)
  • 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 therapy
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bayer Corporation

    Bayer Study Director, Study Director

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00105443
    ClinicalTrials.gov processed this data on May 26, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.