Taiwan ACE Beads for Hepatoma Embolization Therapy

August 6, 2018 updated by: National Cheng-Kung University Hospital

Radiopaque Microsphere (Hydrophilic Series) 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Survival (Safety)
Time Frame: An average of 12 weeks.
Survival rate was evaluated since treatment day until the date of death or final observation.
An average of 12 weeks.
Tumor Response (Efficacy)
Time Frame: Before treatment, one month and three month after T-ACE using CT scan and MRI
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
Time Frame: Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Collaborators

National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
The Industrial Technology Research Institute

Investigators

  • Study Director: Xi-Zhang Lin, Department of Internal Medicine, National Cheng Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (ESTIMATE)

July 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-104-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of Liver

Clinical Trials on Taiwan ACE Beads

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe