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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01798160
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years
* HCC, proven by histology or according to EASL criteria
* Intermediate stage HCC (stage B according to BCLC)
* At least one measurable lesion in magnetic resonance imaging (MRI)
* Tumor load ≤ 50%
* preserved liver function (Child Pugh A and B)
Exclusion Criteria:
* Patients feasible for curative treatment (e.g. resection or local ablation)
* Previous TACE or SIRT
* Chemotherapy during the last 4 weeks
* Child Pugh stage C
* BCLC stage D
* ECOG Performance Status \>0
* Tumor involvement \>50% of the liver
* Extrahepatic tumor
* Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
* Esophageal bleeding during the last 3 months
* Hepatic encephalopathy
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Infiltration or occlusion of the portal vein
* Hepatofugal blood flow in the portal vein
* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
* Contraindications against angiography
* Gravidity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01798160
Study Brief:
Protocol Section:
NCT01798160