Taiwan ACE Beads for Hepatoma Embolization Therapy
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|ClinicalTrials.gov Identifier: NCT02825550|
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Liver||Device: Taiwan ACE Beads||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Experimental: Hepatoma treated using Taiwan ACE Beads
The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.
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.
- Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]Survival rate was evaluated since treatment day until the date of death or final observation.
- Tumor Response (Efficacy) [ Time Frame: Before treatment, one month and three month after T-ACE using CT scan and MRI ]mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
- Serum Level of AFP [ Time Frame: Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure ]Serum Level of AFP [Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure]
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): NCT02825550
|National Cheng Kung University Hospital|
|Study Director:||Xi-Zhang Lin||Department of Internal Medicine, National Cheng Kung University Hospital|