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Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of HCC

- Child-Pugh liver classification of A or B

- Subjects must not have received prior chemotherapy or radiotherapy for their HCC

- At least 18 years of age

- Bidimensionally measurable disease amenable to CT scanning. At least one lesion must
be least 1 X 1 cm in size.

- Karnofsky performance status of at least 70%

- Estimated life expectancy of at least 12 weeks

- Females of childbearing potential must have a negative pregnancy test and agree to
use an effective contraceptive

- Subject must be able to comply with study procedures and follow-up examinations.

- Signed written informed consent

- Lab Values (obtained ≤ 7 days prior to study enrollment):

- ANC at least 1.5x10e9/L,

- Platelet count at least 100x10e9/L,

- Creatinine within 2 times upper limit of normal

- AST and ALT within 5 times upper limit of normal

- Bilirubin within 1.5 times upper limit of normal

- Albumin great than 2.8 g/dL

Exclusion Criteria

- Severe, concurrent disease, infection or co-morbidity that, in the judgment of the
investigator, would make the subject inappropriate for enrollment

- NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%,
or acute anginal symptoms

- Patients who have received any investigational agent within 4 weeks of enrollment

- Patients who are pregnant or breast-feeding

- History of prior malignancy other than cancer studied within the last 5 years, except
for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
of the cervix

- History of central nervous system metastases or carcinomatous meningitis

- Major surgery within 4 weeks of enrollment

- Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or
radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol
injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal
radiation or embolization, is permitted ONLY if > 6 weeks has passed since therapy
and there is an indicator lesion (> 1 x 1 cm) outside the area of prior treatment
(recurrence at the margin or resection is allowed)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Charlene Sum

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular



Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of California San DiegoLa Jolla, California  92093
Ellis Fischel Cancer CenterColumbia, Missouri  65203
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of RochesterRochester, New York  14642
H. Lee Moffitt Cancer CenterTampa, Florida  33612
University of Texas Southwestern Medical CenterDallas, Texas  
Scripps Health CenterLa Jolla, California  92037
George Washington UniversityWashington, District of Columbia  20037
University of New MexicoAlbuquerque, New Mexico  87131