A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial

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.