Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Taiwan ACE Beads for Hepatoma Embolization Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825550
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE July 7, 2016
Results First Submitted Date  ICMJE January 24, 2017
Results First Posted Date  ICMJE August 7, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]
From the date of Taiwan ACE Beads procedure to the date of death or the date of the end of the observation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
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]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
  • Tumor response (Efficacy) by mRECIST criteria. [ Time Frame: One month, and three month by CT scan. ]
  • Serum Level of AFP [ Time Frame: Baseline serum AFP levels compared with one and three months of serum levels of AFP after Taiwan ACE Beads procedure ]
    Blood sampling on admission, discharge, one and three month after Taiwan ACE Beads at outpatient clinics.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Taiwan ACE Beads for Hepatoma Embolization Therapy
Official Title  ICMJE Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of Liver
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Hepatoma treated using Taiwan ACE Beads
The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.
Intervention: Device: Taiwan ACE Beads
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
13
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2016)
12
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825550
Other Study ID Numbers  ICMJE B-BR-104-046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Cheng-Kung University Hospital
Study Sponsor  ICMJE National Cheng-Kung University Hospital
Collaborators  ICMJE
  • The Industrial Technology Research Institute
  • National Cheng Kung University
  • National Research Program for Biopharmaceuticals, Taiwan
Investigators  ICMJE
Study Director: Xi-Zhang Lin Department of Internal Medicine, National Cheng Kung University Hospital
PRS Account National Cheng-Kung University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP