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Trial record 93 of 2028 for:    doxil

Drug-loadable(T-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. Identifier: NCT03299036
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : October 22, 2018
The Industrial Technology Research Institute
National Cheng Kung University
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 with doxorubicin) interventional therapy for patients with liver cancer

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.
Device: Taiwan ACE Beads with doxorubicin
Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.

Primary Outcome Measures :
  1. Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]
    Survival rate will be evaluated since treatment day until the date of death or final observation.

  2. Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria [ Time Frame: Three months ]
    mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.

Secondary Outcome Measures :
  1. Serum Level of AFP [ Time Frame: An average of 12 weeks ]
    Collect Doxorubicin's blood concentration, 5 mL each time

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT03299036

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National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
National Cheng-Kung University Hospital
The Industrial Technology Research Institute
National Cheng Kung University
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Study Director: Xi-Zhang Lin Department of Internal Medicine, National Cheng Kung University Hospital

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Responsible Party: National Cheng-Kung University Hospital Identifier: NCT03299036     History of Changes
Other Study ID Numbers: B-BR-105-054
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cheng-Kung University Hospital:
Transcatheter Arterial chemo-embolization
Additional relevant MeSH terms:
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Liposomal doxorubicin
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action