Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

Biocompatibles LC Bead (also known as DC Bead in Asia & Europe) microspheres are preformed
soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood
flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The
fully polymerized microsphere is approximately 90% water and is compressible to approximately
30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or
micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial
embolization, are mixed with radiographic contrast prior to administration in order to allow
for fluoroscopic control of the embolization procedure.

Inclusion Criteria:

- Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis;
who is not a surgical resection candidate, or refuses surgery

- Patient must be 18 years of age or older

- Patient must be Okuda stage I or II

- Patient must have an ECOG performance status of 0 or 1

- No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all
toxicities, if any, resolved to grade < than or = to 1

- Patient must have the following laboratory values confirmed within 14 days of
registration:

- Creatinine ≤ than or = to 2.0 the institution ULN

- Platelets ≥ than or = to 50,000/mm3

- INR ≤ than or = to 2.0 for patients who are not on Coumadin

- aPTT < or = to twice control

- Bilirubin < 3 mg/dl

- WBC > 3000 cells/mm3

- ANC > 1500 cells/mm3

- Negative serum pregnancy test (Female of childbearing potential only)

Exclusion Criteria:

- Patient has another primary tumor, with the exception of conventional basal cell CA,
superficial bladder cancer, melanoma in situ, or treated prostate cancer currently
without biochemical or radiographic evidence of active disease

- Women who are pregnant or lactating

- Patient previously treated with doxorubicin

- Contraindication to angiography/embolization including: patients who cannot receive
contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal
function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on
judgment of the investigator

- Patient has already undergone hepatic arterial embolization for the hepatocellular
cancer for which they are currently being evaluated

- Patient has received prior radiotherapy for the hepatocellular cancer for which they
are currently being evaluated

- Patient has had previous local-regional treatment of the current target tumor volume

- Patient who cannot have CT scan

- Patient at very high risk for post-embolization hepatic failure: 1. Child's C
cirrhosis, 2. > 75% liver replaced by tumor

- Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2.
uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead

- Patients with tumors exhibiting characteristics considered contra-indications to
particle embolization, including: 1. collateral vessel pathways potentially
endangering normal territories during embolization, 2. arteries supplying tumor not
large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic
venous shunts, 4. Presence of arterial to pulmonary vascular shunts