Taiwan ACE Beads for Hepatoma Embolization Therapy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy

Conditions
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Cancer of Liver

Intervention / Treatment
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* Device: Taiwan ACE Beads


Participation Criteria
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Eligibility Criteria
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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:) Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician. 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatoma treated using Taiwan ACE Beads<br>The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma. | Device: Taiwan ACE Beads<br>* Similar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Survival (Safety) | Survival rate was evaluated since treatment day until the date of death or final observation. | An average of 12 weeks. | 
| Tumor Response (Efficacy) | mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization. | Before treatment, one month and three month after T-ACE using CT scan and MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Level of AFP | Serum Level of AFP [Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure] | Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere