Taiwan ACE Beads for Hepatoma Embolization Therapy
Taiwan ACE Beads for Hepatoma Embolization Therapy
The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere
 (T-ACE Beads) interventional therapy for patients with liver cancer
The study will evaluate the safety and tolerability of Taiwan ACE Beads used for
 chemoembolization for the treatment of unresectable hepatocellular carcinoma.

 The investigators will study the overall response rates of lesions with Taiwan ACE Beads. The
 procedure is similar with conventional TACE (transcatheter arterial chemoembolization). At
 the target vessels, radiologists will inject lipiodol with doxorubicin first, then Taiwan ACE
 Beads instead of Gelfoam or PVA (polyvinyl alcohol). The end point of injection is also
 similar with conventional TACE.

 Determine the complication rates, progression free survival (PFS) and overall survival (OS)
 following Taiwan ACE Beads embolization.
Inclusion Criteria:

 Patients must meet all of the following inclusion criteria in order to be entered into the
 study:

 A. Both genders of patients age 18 or older.

 B. Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)

 1. Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.

 2. High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer
 image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or
 Angiography).

 3. High risk patients (Viral hepatitis B or C cirrhotics) with evidence of enlarging
 image of liver cancer via more than two follow-up records.

 C. In intermediate stage by BCLC staging, tumor size between 3 to 6 centimeters, with liver
 function at Child-Pugh class<9, and is either difficult to accept an operation or reluctant
 to accept any operation.

 D. Disease can be treated by transarterial chemoembolization, and can be evaluated by
 Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT).

 E. Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.

 Exclusion Criteria:

 If patients meet any of the following criteria they may not be entered into the study:

 A. major branch of portal vein has been invaded already; extrahepatic metastasis or the the
 other malignant tumors.

 B. Evidences of decompensation: Total Bilirubin>2, PT prolong>3 seconds, AST > 500U/L, ALT>
 500U/L, Child-Pugh class≧9, refractory ascites, active bleeding, hepatic encephalopathy,
 and severe infection.

 C. Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters.

 D. Cr>2.0 mg/dL and eGFR<50%.

 E. Allergic to iodine or other injections.

 F. Other main organ failure (Heart, Lung, or Kidney)

 G. WBC<3000, ANC<1500.

 H. Performance status ECOG of 3 or more.

 I. Unable to follow-up by ultrasound or CT scan.

 J. Unwilling to sign a written informed consent form.

 K. Pregnant women and breath feeding women.

 L. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.

 M. Prominent AV shunt.

 N. Severe atherosclerosis.

 O. Vasospasm or possible major vascular injury.

 P. Arteriovenous shunt patients, diameter larger than the size of microsphere available.

 Q. Collateral vascular exists and may endanger non-targeted area during arterial
 chemoembolization.

 R. Contraindications for doxorubicin.

 S. Number of tumors more than 3 and locate at different lobes.