Clinical trial · Interventional
Taiwan ACE Beads for Hepatoma Embolization Therapy
Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy
NCT02825550CI-TRIAL-00034184completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Liver | Malignant Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taiwan ACE Beads | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hepatoma treated using Taiwan ACE Beads
- description
- The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.
- interventionNames
- Device: Taiwan ACE Beads
Primary outcomes (2)
- measure
- Patients Survival (Safety)
- timeFrame
- An average of 12 weeks.
- description
- Survival rate was evaluated since treatment day until the date of death or final observation.
- measure
- Tumor Response (Efficacy)
- timeFrame
- Before treatment, one month and three month after T-ACE using CT scan and MRI
- description
- mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDLiu 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. PMID 26339465
- BACKGROUNDChen CY, Liu HS, Lin XZ. Hydrodynamics-based gene delivery to the liver by bile duct injection of plasmid DNA--the impact of lasting biliary obstruction and injection volume. Hepatogastroenterology. 2005 Jan-Feb;52(61):25-8. PMID 15782986
- BACKGROUNDLuo TY, Shih YH, Chen CY, Tang IC, Wu YL, Kung HC, Lin WJ, Lin XZ. Evaluating the potential of (188)Re-ECD/lipiodol as a therapeutic radiopharmaceutical by intratumoral injection for hepatoma treatment. Cancer Biother Radiopharm. 2009 Oct;24(5):535-41. doi: 10.1089/cbr.2008.0603. PMID 19877883