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Taiwan ACE Beads for Hepatoma Embolization Therapy

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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

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

Condition or disease Intervention/treatment Phase
Cancer of Liver Device: Taiwan ACE Beads Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825550


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
National Cheng-Kung University Hospital
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
Investigators
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Study Director: Xi-Zhang Lin Department of Internal Medicine, National Cheng Kung University Hospital
Publications:
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02825550    
Other Study ID Numbers: B-BR-104-046
First Posted: July 7, 2016    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Cheng-Kung University Hospital:
Hepatoma
Transcatheter Arterial chemo-embolization
Microsphere
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases