Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-10-16

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads with doxorubicin) interventional therapy for patients with liver cancer

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Detailed Description

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The study will evaluate the safety and tolerability of Taiwan ACE Beads with doxorubicin 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 the other commercializing drug-eluting beads. At the target vessels, radiologists will inject doxorubicin with 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.

Conditions

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Cancer of Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Taiwan ACE Beads with doxorubicin

The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.

Group Type EXPERIMENTAL

Taiwan ACE Beads with doxorubicin

Intervention Type DEVICE

Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.

Interventions

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Taiwan ACE Beads with doxorubicin

Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

A. Both genders of patients age 20 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 under 8 centimeters, with liver function at Child-Pugh class ≤ 8, 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, Child-Pugh class\>8, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.

C. Tumor size (diameter) larger than 8 centimeters.

D. Not on dialysis with Creatinine \>2.0 mg/dL.

E. Allergic to iodine or other injections.

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

G. WBC\<3000, or Platelet Count \<50,000 mg/dL.

H. Performance status ECOG of 3 or more.

I. Pregnant women and breath feeding women.

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

K. Prominent AV shunt.

L. Severe atherosclerosis.

M. Vasospasm or possible major vascular injury.

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

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

P. Contraindications for doxorubicin.

Q. Numerous of tumors locate at different lobes, high risk of Hepatic insufficiency.

R. Unwilling to sign a written informed consent form.

S. Allergic to pharmaceutical excipients related to Microspheres.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No