Trial Outcomes & Findings for Taiwan ACE Beads for Hepatoma Embolization Therapy (NCT NCT02825550)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

An average of 12 weeks.

Results posted on

2018-08-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Hepatoma Patients Treated With T-ACE Beads 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.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Hepatoma Patients Treated With T-ACE Beads 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.
Overall Study Physician Decision	1

Baseline Characteristics

Taiwan ACE Beads for Hepatoma Embolization Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatoma Treated Using Taiwan ACE Beads n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age, Continuous	71 years STANDARD_DEVIATION 8 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment Taiwan	12 participants n=99 Participants

PRIMARY outcome

Timeframe: An average of 12 weeks.

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

Outcome measures

Outcome measures
Measure	Hepatoma Treated Using Taiwan ACE Beads n=12 Participants 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.
Patients Survival (Safety)	12 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hepatoma Treated Using Taiwan ACE Beads n=12 Participants 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.
Tumor Response (Efficacy) Target Lesions · Complete Remission (CR)	3 Participants
Tumor Response (Efficacy) Target Lesions · Partial Response (PR)	4 Participants
Tumor Response (Efficacy) Target Lesions · Stable Disease (SD)	3 Participants
Tumor Response (Efficacy) Target Lesions · Progressive Disease (PD)	2 Participants
Tumor Response (Efficacy) Overall Response · Complete Remission (CR)	2 Participants
Tumor Response (Efficacy) Overall Response · Partial Response (PR)	3 Participants
Tumor Response (Efficacy) Overall Response · Stable Disease (SD)	3 Participants
Tumor Response (Efficacy) Overall Response · Progressive Disease (PD)	4 Participants

SECONDARY outcome

Timeframe: Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure

Serum Level of AFP \[Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure\]

Outcome measures

Outcome measures
Measure	Hepatoma Treated Using Taiwan ACE Beads n=12 Participants 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.
Serum Level of AFP Baseline serum AFP levels	168 ng/mL Standard Deviation 383
Serum Level of AFP one or three months of serum levels of AFP	144 ng/mL Standard Deviation 256

Adverse Events

Adverse Event

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Xi-Zhang Lin

Department of Internal Medicine, National Cheng Kung University

Phone: 886-6-2353535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place