- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299036
Drug-loadable(T-ACE Beads)for Hepatoma Embolization Therapy
Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 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.
Study Plan
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: Taiwan ACE Beads with doxorubicin
The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.
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Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients Survival (Safety)
Time Frame: An average of 12 weeks.
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Survival rate will be evaluated since treatment day until the date of death or final observation.
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An average of 12 weeks.
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Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
Time Frame: Three months
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mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
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Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Level of AFP
Time Frame: An average of 12 weeks
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Collect Doxorubicin's blood concentration, 5 mL each time
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An average of 12 weeks
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Collaborators and Investigators
Investigators
- Study Director: Xi-Zhang Lin, Department of Internal Medicine, National Cheng Kung University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
Other Study ID Numbers
- B-BR-105-054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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