Taiwan ACE Beads for Hepatoma Embolization Therapy
Cancer of Liver
Bottom Line
View on ClinicalTrials.gov: NCT02825550 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Taiwan ACE Beads (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cheng-Kung University Hospital
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Survival (Safety) |
12 | — |
| PRIMARY Tumor Response (Efficacy) |
3; 4; 3; 2; 2; 3 | — |
| SECONDARY Serum Level of AFP |
168; 144 | — |
Summary
Eligibility Criteria
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:)
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02825550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.