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:
NCT02323360
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Karnofsky index \>70%
* Child-Turgotte-Pugh A or B liver score.
* An initial diagnosis of primary HCC or recurrence.
* A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
* HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
* Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
* Hb \>10.5.0 g/%, WBC \>3.000 cells/mm3, platelets \>50.000 cells/mm3, bilirubin \<2 mg/dl, aspartate and alanine aminotransferase levels \<5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
* Serum creatinine \<1.7 mg/dl
* Previously incomplete TAE or TACE with radiologically defined residual disease.
* Informed consent
Exclusion Criteria:
* Extrahepatic disease and refractory ascites.
* Previous abdominal radiation therapy (RT)
* Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
* Pregnant or breastfeeding patients.
* Patients with uncontrolled infections or HIV seropositive patients.
* Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT02323360
Study Brief:
Protocol Section:
NCT02323360