A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

1. Male or female patients ≥ 18 years of age

2. A life expectancy of at least 12 weeks with a Karnofsky performance
status of at least 70 (Appendix III)

3. HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the
following criteria must be met or a biopsy is required: • Known cirrhosis or chronic
HBV or HCV infection, • Hypervascular liver masses >2 cm, and either serum AFP > 400
ng/ml, or • AFP >three times normal and doubling in value in the antecedent 3 months.

4. The target lesion(s) can be accurately measured in at least one dimension according
to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.

5. No prior radiotherapy to the liver.

6. Previous systemic chemotherapy or non-radiation local therapy (such as surgery,
hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous
ethanol injection or cryoablation) is allowed. The lesion must however have shown
criteria of progression based on RECIST. Local therapy must be completed at least 4
weeks prior to the baseline scan.

7. Cirrhotic status of Child-Pugh class A or B (Appendix I)

8. Patient's lesions are deemed unresectable.

9. Patient's tumor burden or medical comorbidities disqualify them for transplant OR the
patient qualifies for transplant but refuses the operation OR patients planned for
TACE as a bridge to transplant operation.

10. Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International
normalized ratio (INR) ≤ 1.5 or a PT/PTT within normal limits. Patients who are
being therapeutically anticoagulated with an agent such as Coumadin or heparin will
be allowed to participate provided that no prior evidence of underlying abnormality
in these parameters exists.

11. Other baseline labs must meet the following criteria: total bilirubin <3mg/dl,
albumin>2.5mg/dl, and liver enzymes less than three times the upper limit of normal.
Creatinine must also be <1.8mg/dl or a creatinine clearance >50ml/min.

12. Must be aware of the neoplastic nature of his/her disease and willingly provide
written, informed consent after being informed of the procedure to be followed, the
nature of the therapy, alternatives, potential benefits, side-effects, risks and
discomforts.

Exclusion Criteria:

1. Renal failure requiring hemo- or peritoneal dialysis

2. Uncontrolled inter-current illness (except Hepatitis) including, but not limited to
ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common
Terminology Criteria for Adverse Events [CTCAE] version 3.0), congestive heart
failure (> New York Heart Association (NYHA) class 2), active coronary artery disease
(CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
or digoxin), uncontrolled hypertension and any condition which could jeopardize the
safety of the patient and his/her compliance in the study . Myocardial infarction
more than 6 months prior to study entry is permitted.

3. A history of variceal bleeding where the varices have not been eradicated or
decompressed by shunt placement.

4. History of an active connective tissue disorder.

5. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

6. Pregnant or breast-feeding patients are excluded from this study because abdominal
radiation therapy has potential for teratogenic and/or abortifacient effects.

7. Total portal vein occlusion.

8. Extensive liver tumor burden, defined as more than 75% of the liver.

9. Previous or current malignancies of other histologies within the last 5 years, with
the exception of cervical carcinoma in situ and adequately treated basal cell or
squamous cell carcinoma of the skin.

10. Patients with uncontrolled distant disease will be excluded from this protocol.
Those with controlled systemic disease will still be eligible.