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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.
National Cheng Kung University Hospital
Tainan, Taiwan
Patients Survival (Safety)
Survival rate will be evaluated since treatment day until the date of death or final observation.
Time frame: An average of 12 weeks.
Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
Time frame: Three months
Serum Level of AFP
Collect Doxorubicin's blood concentration, 5 mL each time
Time frame: An average of 12 weeks
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