NCT02825550

Taiwan ACE Beads for Hepatoma Embolization Therapy

Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study will evaluate the safety and tolerability of Taiwan ACE Beads 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 conventional TACE (transcatheter arterial chemoembolization). At the target vessels, radiologists will inject lipiodol with doxorubicin first, then 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.

Conditions

• Cancer of Liver

Interventions

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

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2016-07-07
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

1 site across 1 country: Taiwan