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

Primary Purpose

Cancer of Liver

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Taiwan ACE Beads with doxorubicin
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Liver focused on measuring Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere, Doxorubicin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Taiwan ACE Beads with doxorubicin

Arm Description

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

Outcomes

Primary Outcome Measures

Patients Survival (Safety)
Survival rate will be evaluated since treatment day until the date of death or final observation.
Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.

Secondary Outcome Measures

Serum Level of AFP
Collect Doxorubicin's blood concentration, 5 mL each time

Full Information

First Posted
September 20, 2017
Last Updated
October 18, 2018
Sponsor
National Cheng-Kung University Hospital
Collaborators
The Industrial Technology Research Institute, National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT03299036
Brief Title
Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy
Official Title
Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
The Industrial Technology Research Institute, National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Liver
Keywords
Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere, Doxorubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taiwan ACE Beads with doxorubicin
Arm Type
Experimental
Arm Description
The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.
Intervention Type
Device
Intervention Name(s)
Taiwan ACE Beads with doxorubicin
Intervention Description
Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.
Primary Outcome Measure Information:
Title
Patients Survival (Safety)
Description
Survival rate will be evaluated since treatment day until the date of death or final observation.
Time Frame
An average of 12 weeks.
Title
Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
Description
mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Serum Level of AFP
Description
Collect Doxorubicin's blood concentration, 5 mL each time
Time Frame
An average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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 20 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi-Zhang Lin
Organizational Affiliation
Department of Internal Medicine, National Cheng Kung University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26339465
Citation
Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
Results Reference
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PubMed Identifier
25598680
Citation
Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, Chuang MT. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015 Jan-Feb;16(1):125-32. doi: 10.3348/kjr.2015.16.1.125. Epub 2015 Jan 9.
Results Reference
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Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy

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