Carcinoma, Hepatocellular
Conditions
Brief summary
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
Interventions
DRUGThymalfasin (thymosin alpha-1)
PROCEDURETrans arterial chemoembolization (TACE)
Sponsors
SciClone Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent. * Diagnosis of HCC by: 1. Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by: 2. A new hepatic defect on imaging with an AFP \> 1000 ng/ml, or 3. A new hepatic defect on ultrasound or CT with an AFP \< 1000 ng/ml when one of the following is present: 1. At least two additional imaging techniques show signs characteristic of HCC, or 2. The new hepatic defect has doubled in diameter over time, or 3. The AFP has progressively risen to \> 200 ng/ml and triples the mean baseline. * HCC must be unresectable and non-transplantable. * Hematocrit \> 30%, platelet count \>= 50,000 per microliter, WBC \> 2.0 x 109/L, and polymorphonuclear white cell count \>= 1.0 x 109/L. * Adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/dl. * If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.
Exclusion criteria
* Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient). * Presence of main portal vein thrombosis or hepatic artery malformation. * HCC amenable to treatment by surgical resection or hepatic transplantation. * HIV infection diagnosed by HIV seropositivity and confirmed by Western blot. * Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix. * Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature. * Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study. * Alcohol or intravenous drug abuse within the previous 1 year. * Previous treatment with thymalfasin. * Patients with known hypersensitivity to iodine. * Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
Countries
United States
Outcome results
None listed