Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT02825550
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:)
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02825550
Study Brief:
Protocol Section:
NCT02825550