Know Cancer

forgot password

Phase 2/Phase 3
18 Years
Not Enrolling
Hepatocellular Carcinoma

Thank you

Trial Information

Inclusion Criteria

Key inclusion criteria include:

- pathologic diagnosis of unresectable HCC

- chemotherapy-naïve for HCC

- Child-Pugh Class A or B liver disease

- measurable disease (i.e., at least one lesion that is at least 20 mm in one
dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI)
or at least one lesion that is at least 10 mm on spiral CT scan

- Karnofsky Performance Status of ≥ 70%

- life expectancy of ≥ 12 weeks

- adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500
cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)

- total bilirubin of ≤ 1.5 upper limit of normal (ULN)

- aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN

- serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

- severe, concurrent disease that would make the subject inappropriate for enrollment

- Subjects who have received prior intravenous or intra-arterial chemotherapy,
chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency
ablation, or embolization for their HCC. (note: prior surgical resection,
immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver
transplantation are allowed)

- history of other cancer within the past 5 years other than adequately treated basal
cell or squamous cell skin cancer, or carcinoma in situ of the cervix

- New York Heart Association (NYHA) class III or IV heart disease or a left ventricular
ejection fraction of <50% or acute anginal symptoms

- females who are pregnant or breast-feeding

- received any investigational agent within 4 weeks of enrollment

- history of central nervous system metastases or carcinomatous meningitis

- clinically apparent ascites

- major surgery within 4 weeks of study enrollment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mohammad Hirmand, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • liver cancer
  • Carcinoma
  • Carcinoma, Hepatocellular



University of Alabama Birmingham, Alabama  
University of Pennsylvania Philadelphia, Pennsylvania  19104
H. Lee Moffitt Cancer Center Tampa, Florida  33612
University of Miami Miami, Florida  33136
University of California at San Francisco San Francisco, California  94115
VA Medical Center Miami, Florida  33125
Loyola University of Chicago Maywood, Illinois  60153
UT Southwestern Medical Center - Dallas Dallas, Texas  75390-9125