Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy

NCT03299036 | Completed DMC

• 1 other identifier: B-BR-105-054
• Study Type: interventional
• Target: 12
• 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 with doxorubicin) interventional therapy for patients with liver cancer

Conditions

Cancer of Liver

Keywords

Hepatoma; Transcatheter Arterial chemo-embolization; Microsphere; Doxorubicin

Outcome Measures

Primary Outcomes (2)

• Patients Survival (Safety)

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

  An average of 12 weeks.

• Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria

  mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.

  Three months

Secondary Outcomes (1)

• Serum Level of AFP

  An average of 12 weeks

Study Arms (1)

Taiwan ACE Beads with doxorubicin

EXPERIMENTAL

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

Device: Taiwan ACE Beads with doxorubicin

Interventions

Taiwan ACE Beads with doxorubicin DEVICE

Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.

Taiwan ACE Beads with doxorubicin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Both genders of patients age 20 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 under 8 centimeters, with liver function at Child-Pugh class ≤ 8, 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, Child-Pugh class\>8, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.
• C. Tumor size (diameter) larger than 8 centimeters.
• D. Not on dialysis with Creatinine \>2.0 mg/dL.
• E. Allergic to iodine or other injections.
• F. Other main organ failure (Heart, Lung, or Kidney).
• G. WBC\<3000, or Platelet Count \<50,000 mg/dL.
• H. Performance status ECOG of 3 or more.
• I. Pregnant women and breath feeding women.
• J. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.
• K. Prominent AV shunt.
• L. Severe atherosclerosis.
• M. Vasospasm or possible major vascular injury.
• N. Arteriovenous shunt patients, diameter larger than the size of microsphere available.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• The Industrial Technology Research Institute: collaborator
• National Cheng Kung University: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Related Publications (2)

• 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

• Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, Chuang MT. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015 Jan-Feb;16(1):125-32. doi: 10.3348/kjr.2015.16.1.125. Epub 2015 Jan 9.

  PMID: 25598680 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

Study Officials

• Xi-Zhang Lin

  Department of Internal Medicine, National Cheng Kung University Hospital

  STUDY DIRECTOR

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: September 20, 2017
• First Posted: October 2, 2017
• Study Start: June 1, 2017
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)