CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Taiwan ACE Beadsdevice
Likely dose
Lipiodol with doxorubicin followed by Taiwan ACE BeadsAI-extracted
Key inclusion· 5
  • ✓Age 18 or older, both genders
  • ✓Confirmed diagnosis of hepatocellular carcinoma by biopsy OR imaging criteria in high-risk patients
  • ✓BCLC intermediate stage with tumor diameter 3-6 cm and Child-Pugh class <9
  • ✓Candidate for transarterial chemoembolization and evaluable by imaging (ultrasound, MRI, or CT)
Key exclusion· 11
  • ✕Portal vein invasion, extrahepatic metastases, or other malignancies
  • ✕Evidence of hepatic decompensation: total bilirubin >2, PT >3 seconds, AST >500, ALT >500, Child-Pugh ≥9, refractory ascites, active bleeding, encephalopathy, or severe infection
  • ✕Tumor diameter <3 cm or >6 cm
  • ✕Renal dysfunction: creatinine >2.0 mg/dL or eGFR <50%

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02825550
NCT02825550N/ACompleted
CompareCT.gov

Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy

National Cheng-Kung University Hospital·interventional·Posted Jul 7, 2016·Updated Aug 7, 2018

In Brief

A clinical study evaluating Taiwan ACE Beads for Cancer of Liver. Completed, enrolled 13 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of Liver
CountriesTaiwan
CollaboratorsThe Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 7, 2016
Enrollment StartApr 1, 2016
Primary CompletionDec 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.0 years ago

Interventions

Taiwan ACE Beadsdevice

Similar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.