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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02093104
Eligibility Criteria:
Inclusion Criteria:
1. Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of hepatocellular carcinoma (HCC) and at least one uni-dimensional lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria by CT-scan
2. OR radiologic evidence of liver metastatic disease
3. Amenable to embolization or ablation as adjuvant, neoadjuvant or definitive (curative or palliative) therapy.
4. Adult \> 19 years old and estimated life expectancy over 3 months
5. Eastern Cooperative Oncology Group (ECOG) performance status under or equals 1
6. Adequate haematological function: Hb over or equals 9g/100mL, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
7. Adequate renal function; serum creatinine under 150μmol/L
8. Bilirubin under or equals 50 µmol/L, Aspartate aminotransferase (AST) or ALT uner or equals 5 x upper limit of normal (ULN), international normalized ratio (INR) under or equals 1.5
9. Liver cirrhosis Child Pugh A - B7
10. Ability to provide written informed consent
Exclusion Criteria:
1. Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy
2. Women who are pregnant or breast feeding
3. Allergy to contrast media
4. Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation OR contraindication to locally curative ablation due to size, location or shape.
5. Psychiatric or other disorder likely to impact on informed consent
6. Patient unable and/or unwilling to comply with treatment and study instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02093104
Study Brief:
Protocol Section:
NCT02093104