NCT03299036

Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy

Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cancer of Liver

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2017-10-02
• Last updated: 2018-10-22

Locations

1 site across 1 country: Taiwan