Cancer of LiverNCT02825550

Taiwan ACE Beads for Hepatoma Embolization Therapy

A study testing Taiwan ACE Beads in people with Cancer of Liver, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads) interventional therapy for patients with liver cancer Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer of Liver
What is being tested?: Taiwan ACE Beads
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteTaiwan
Study dates: Apr 2016to Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must meet all of the following inclusion criteria in order to be entered into the study:
Both genders of patients age 18 or older.
Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)
Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.
High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or Angiography).
High risk patients (Viral hepatitis B or C cirrhotics) with evidence of enlarging image of liver cancer via more than two follow-up records.

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In intermediate stage by BCLC staging, tumor size between 3 to 6 centimeters, with liver function at Child-Pugh class<9, and is either difficult to accept an operation or reluctant to accept any operation.
Disease can be treated by transarterial chemoembolization, and can be evaluated by Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT).
Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.

Who cannot join

If patients meet any of the following criteria they may not be entered into the study:
major branch of portal vein has been invaded already; extrahepatic metastasis or the the other malignant tumors.
Evidences of decompensation: Total Bilirubin>2, PT prolong>3 seconds, AST > 500U/L, ALT> 500U/L, Child-Pugh class≧9, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.
Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters.
Cr>2.0 mg/dL and eGFR<50%.
Allergic to iodine or other injections.

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Other main organ failure (Heart, Lung, or Kidney)
WBC<3000, ANC<1500.
Performance status ECOG of 3 or more.
Unable to follow-up by ultrasound or CT scan.
Unwilling to sign a written informed consent form.
Pregnant women and breath feeding women.
Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.
Prominent AV shunt.
Severe atherosclerosis.
Vasospasm or possible major vascular injury.
Arteriovenous shunt patients, diameter larger than the size of microsphere available.
Collateral vascular exists and may endanger non-targeted area during arterial chemoembolization.
Contraindications for doxorubicin.
Number of tumors more than 3 and locate at different lobes.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Cheng Kung University Hospital
Tainan

Other trials in Taiwan

About this study

Official title: Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy

The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads) interventional therapy for patients with liver cancer

Read the detailed description

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.

Conditions: Cancer of Liver
Being tested: Taiwan ACE Beads
Keywords: Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere
Medical subject headings: Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Taiwan ACE BeadsDevice
Similar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.

Study groups in NCT02825550
Study group	Role	What they receive
Hepatoma treated using Taiwan ACE Beads	Experimental	The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma. Receives: Device: Taiwan ACE Beads

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients Survival (Safety)
Survival rate was evaluated since treatment day until the date of death or final observation.
Measured: An average of 12 weeks.
Tumor Response (Efficacy)
mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
Measured: Before treatment, one month and three month after T-ACE using CT scan and MRI

Secondary outcomes (1)

Serum Level of AFP
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]
Measured: Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Jan 2017

First posted7 Jul 2016 (estimated)
Study startApr 2016
Primary completionDec 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cancer of LiverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02825550
Sponsor's protocol ID: B-BR-104-046
Status last verified: Aug 2018
First submitted: 2 Jun 2016
Last updated: 7 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
PubMed 26339465
Chen CY, Liu HS, Lin XZ. Hydrodynamics-based gene delivery to the liver by bile duct injection of plasmid DNA--the impact of lasting biliary obstruction and injection volume. Hepatogastroenterology. 2005 Jan-Feb;52(61):25-8.
PubMed 15782986
Luo TY, Shih YH, Chen CY, Tang IC, Wu YL, Kung HC, Lin WJ, Lin XZ. Evaluating the potential of (188)Re-ECD/lipiodol as a therapeutic radiopharmaceutical by intratumoral injection for hepatoma treatment. Cancer Biother Radiopharm. 2009 Oct;24(5):535-41. doi: 10.1089/cbr.2008.0603.
PubMed 19877883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy
ClinicalTrials.gov ID: NCT02825550
Acronym / sponsor ID: B-BR-104-046
Conditions: Cancer of Liver
Keywords: Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: National Cheng-Kung University HospitalUniversity, hospital or other
Collaborators: The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan
Study start: Apr 2016 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 7 Jul 2016 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads) interventional therapy for patients with liver cancer

Detailed description

The study will evaluate the safety and tolerability of Taiwan ACE Beads used for chemoembolization for the treatment of unresectable hepatocellular carcinoma.

Determine the complication rates, progression free survival (PFS) and overall survival (OS) following Taiwan ACE Beads embolization.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hepatoma treated using Taiwan ACE Beads	Experimental	Device: Taiwan ACE BeadsThe use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients must meet all of the following inclusion criteria in order to be entered into the study:
Both genders of patients age 18 or older.
Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)
Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.
High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or Angiography).

Key exclusion criteria (20 listed)

major branch of portal vein has been invaded already; extrahepatic metastasis or the the other malignant tumors.
Evidences of decompensation: Total Bilirubin>2, PT prolong>3 seconds, AST > 500U/L, ALT> 500U/L, Child-Pugh class≧9, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.
Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters.
Cr>2.0 mg/dL and eGFR<50%.
Allergic to iodine or other injections.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Taiwan ACE BeadsSimilar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.	Device	Hepatoma treated using Taiwan ACE Beads

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 7 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hepatoma Patients Treated With T-ACE Beads	13	12

Primary outcome: Patients Survival (Safety)

Time frame: An average of 12 weeks.. Count of participants. Unit: Participants

Measure	Hepatoma Treated Using Taiwan ACE Beads n = 12
Value	12

Primary outcome: Tumor Response (Efficacy)

Time frame: Before treatment, one month and three month after T-ACE using CT scan and MRI. Count of participants. Unit: Participants

Measure	Hepatoma Patients Treated With T-ACE Beads n = 12
Target Lesions: Complete Remission (CR)	3
Target Lesions: Partial Response (PR)	4
Target Lesions: Stable Disease (SD)	3
Target Lesions: Progressive Disease (PD)	2
Overall Response: Complete Remission (CR)	2
Overall Response: Partial Response (PR)	3
Overall Response: Stable Disease (SD)	3
Overall Response: Progressive Disease (PD)	4

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Event	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): 1. Case number : only 12 patients completed trial. 2. Tumor size limited to 3-6 cm only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26339465Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
Background: PubMed 15782986Chen CY, Liu HS, Lin XZ. Hydrodynamics-based gene delivery to the liver by bile duct injection of plasmid DNA--the impact of lasting biliary obstruction and injection volume. Hepatogastroenterology. 2005 Jan-Feb;52(61):25-8.
Background: PubMed 19877883Luo TY, Shih YH, Chen CY, Tang IC, Wu YL, Kung HC, Lin WJ, Lin XZ. Evaluating the potential of (188)Re-ECD/lipiodol as a therapeutic radiopharmaceutical by intratumoral injection for hepatoma treatment. Cancer Biother Radiopharm. 2009 Oct;24(5):535-41. doi: 10.1089/cbr.2008.0603.
Individual participant dataSharing planned: No

Related trials for Cancer of Liver

RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
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RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xi-Zhang Lin study director

Department of Internal Medicine, National Cheng Kung University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Taiwan ACE Beads in people with Cancer of Liver, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients Survival (Safety) (time frame: An average of 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02825550, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.