Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy
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|ClinicalTrials.gov Identifier: NCT03299036|
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Liver||Device: Taiwan ACE Beads with doxorubicin||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||October 16, 2018|
|Actual Study Completion Date :||October 16, 2018|
Experimental: Taiwan ACE Beads with doxorubicin
The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.
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.
- Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]Survival rate will be evaluated since treatment day until the date of death or final observation.
- Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria [ Time Frame: Three months ]mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
- Serum Level of AFP [ Time Frame: An average of 12 weeks ]Collect Doxorubicin's blood concentration, 5 mL each time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299036
|National Cheng Kung University Hospital|
|Study Director:||Xi-Zhang Lin||Department of Internal Medicine, National Cheng Kung University Hospital|