Taiwan ACE Beads for Hepatoma Embolization Therapy

Cancer of Liver Clinical Trial

Official title:

Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825550
• Other study ID #: B-BR-104-046
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2018
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients must meet all of the following inclusion criteria in order to be entered into the study:

A. Both genders of patients age 18 or older.

B. Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)

1. Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.

2. 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).

3. 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.

Exclusion Criteria:

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.

O. Vasospasm or possible major vascular injury.

P. Arteriovenous shunt patients, diameter larger than the size of microsphere available.

Q. Collateral vascular exists and may endanger non-targeted area during arterial chemoembolization.

R. Contraindications for doxorubicin.

S. Number of tumors more than 3 and locate at different lobes.

Related Conditions & MeSH terms

• Cancer of Liver
• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (4)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan, The Industrial Technology Research Institute

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Survival (Safety)	Survival rate was evaluated since treatment day until the date of death or final observation.	An average of 12 weeks.
Primary	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	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]	Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure