Status:
COMPLETED
Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
The Industrial Technology Research Institute
National Cheng Kung University
Conditions:
Cancer of Liver
Eligibility:
All Genders
20+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03299036
Start Date
June 1 2017
End Date
October 16 2018
Last Update
October 22 2018
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan