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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
Sponsor:
Collaborators:
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer of Liver
Intervention Device: Taiwan ACE Beads
Enrollment 13
Recruitment Details The recruitment started in April, 2016. The location was all taken place in National Cheng Kung University Hospital. Patients who met inclusion criteria were recruited.
Pre-assignment Details  
Arm/Group Title Hepatoma Patients Treated With T-ACE Beads
Hide Arm/Group Description In the Hepatoma Embolization Therapy, the catheter was placed to the appropriate position in tumor-supplying artery. Lipiodol containing doxorubicin were firstly injected, followed by the injection of our T-ACE beads-H series microspheres. The follow-up blood tests and adverse events were conducted afterwards. CT scan or MRI would be scheduled at the first and the third months to evaluate the change of tumor size.
Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Hepatoma Treated Using Taiwan ACE Beads
Hide Arm/Group Description Clinical information of T-ACE beads H-series: Gender Male/Female 7/5, Age 71±8. The initial number of participants in the study was 13. However, one patient's blood test did not meet the standard before the operation, which led to his/her withdrawal from the clinical trial. Consequently, the total number of participants analyzed was 12.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  16.7%
>=65 years
10
  83.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
71  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 12 participants
12
1.Primary Outcome
Title Patients Survival (Safety)
Hide Description Survival rate was evaluated since treatment day until the date of death or final observation.
Time Frame An average of 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hepatoma Treated Using Taiwan ACE Beads
Hide Arm/Group Description:

Hepatoma patients received Taiwan ACE Beads (T-ACE) microspheres embolization to treat the tumors.

Taiwan ACE Beads: The procedure is similar with conventional TACE. Radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.

Survival rate was evaluated since beginning of treatment until date of death or final observation.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
2.Primary Outcome
Title Tumor Response (Efficacy)
Hide Description mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
Time Frame Before treatment, one month and three month after T-ACE using CT scan and MRI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hepatoma Patients Treated With T-ACE Beads
Hide Arm/Group Description:
We have 7 male and 5 female patients eligible in this study, HBV 4+1, HCV5+1, non-HBV and non-HCV 2, mean age 71± 8. Two patient received treatment at the first time. The other 10 patients received RFA 13 times, and TACE 23 times, and surgery 2 times. The response of the target lesions are: CR 3 PR 4 SD 3 PD 2 (for target lesions), and CR 2 PR 3 SD 3 PD 4 (for the overall response). Liver function, serological ALT(35±24) had mild elevation on the second day (61±47), but all return to baseline (40±20). AFP decreased from 168± 382 to 156± 264. [Conclusion] Our T-ACE Beads are safe and has some effects in treating hepatoma patients.For further clinical trials, loading appropriate chemotherapeutic agents to our microspheres for TACE is needed.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Target Lesions Complete Remission (CR)
3
  25.0%
Partial Response (PR)
4
  33.3%
Stable Disease (SD)
3
  25.0%
Progressive Disease (PD)
2
  16.7%
Overall Response Complete Remission (CR)
2
  16.7%
Partial Response (PR)
3
  25.0%
Stable Disease (SD)
3
  25.0%
Progressive Disease (PD)
4
  33.3%
3.Secondary Outcome
Title Serum Level of AFP
Hide Description 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]
Time Frame Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hepatoma Treated Using Taiwan ACE Beads
Hide Arm/Group Description:

Hepatoma patients received Taiwan ACE Beads (T-ACE) microspheres embolization to treat the tumors.

Taiwan ACE Beads: The procedure is similar with conventional TACE. Radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline serum AFP levels 168  (383)
one or three months of serum levels of AFP 144  (256)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Event
Hide Arm/Group Description There was no adverse event reported in this trial.
All-Cause Mortality
Adverse Event
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Serious Adverse Events
Adverse Event
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Event
Affected / at Risk (%)
Total   0/13 (0.00%) 
  1. Case number : only 12 patients completed trial.
  2. Tumor size limited to 3-6 cm only.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Xi-Zhang Lin
Organization: Department of Internal Medicine, National Cheng Kung University
Phone: 886-6-2353535 ext 3624/5603
EMail: linxz@mail.ncku.edu.tw
Layout table for additonal information
Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02825550    
Other Study ID Numbers: B-BR-104-046
First Submitted: June 2, 2016
First Posted: July 7, 2016
Results First Submitted: January 24, 2017
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018