Taiwan ACE Beads for Hepatoma Embolization Therapy

NCT02825550 | Completed Results DMC

• 1 other identifier: B-BR-104-046
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cancer of Liver

Keywords

Hepatoma; Transcatheter Arterial chemo-embolization; Microsphere

Outcome Measures

Primary Outcomes (2)

• Patients Survival (Safety)

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

  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.

  Before treatment, one month and three month after T-ACE using CT scan and MRI

Secondary Outcomes (1)

• Serum Level of AFP

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

Study Arms (1)

Hepatoma treated using Taiwan ACE Beads

EXPERIMENTAL

The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.

Device: Taiwan ACE Beads

Interventions

Taiwan ACE Beads DEVICE

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

Hepatoma treated using Taiwan ACE Beads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Both genders of patients age 18 or older.
• B. 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.
• C. 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.
• D. Disease can be treated by transarterial chemoembolization, and can be evaluated by Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT).
• E. Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.

You may not qualify if:

• If patients meet any of the following criteria they may not be entered into the study:
• A. major branch of portal vein has been invaded already; extrahepatic metastasis or the the other malignant tumors.
• B. 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.
• C. Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters.
• D. Cr\>2.0 mg/dL and eGFR\<50%.
• E. Allergic to iodine or other injections.
• F. Other main organ failure (Heart, Lung, or Kidney)
• G. WBC\<3000, ANC\<1500.
• H. Performance status ECOG of 3 or more.
• I. Unable to follow-up by ultrasound or CT scan.
• J. Unwilling to sign a written informed consent form.
• K. Pregnant women and breath feeding women.
• L. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.
• M. Prominent AV shunt.
• N. Severe atherosclerosis.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• The Industrial Technology Research Institute: collaborator
• National Cheng Kung University: collaborator
• National Research Program for Biopharmaceuticals, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 26339465 BACKGROUND

• 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.

  PMID: 15782986 BACKGROUND

• 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.

  PMID: 19877883 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

1. Case number : only 12 patients completed trial. 2. Tumor size limited to 3-6 cm only.

Results Point of Contact

• Title: Dr. Xi-Zhang Lin
• Organization: Department of Internal Medicine, National Cheng Kung University

linxz@mail.ncku.edu.tw

886-6-2353535

Study Officials

• Xi-Zhang Lin

  Department of Internal Medicine, National Cheng Kung University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 7, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)