A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

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.