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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT01387503
Eligibility Criteria:
Inclusion Criteria:
* Patient's age ≥ 18 yrs and ≤ 65 yrs
* Presence of cirrhosis of any etiology
* Child-Pugh class ≤ B7
* ECOG Performance Status ≤ 1
* Diagnosis of HCC either by biopsy or according to AASLD criteria
* HCC exceeding Milan Criteria with a 5-yr estimated survival after transplantation \>50% according to the Metroticket calculator (http://www.hcc-olt-metroticket.org/calculator)
* Women of child bearing potential with a negative serum pregnancy test performed before enrolment
* Absence of general contraindications to sorafenib/molecular targeted therapies
Exclusion Criteria:
* Presence of extra-hepatic tumor spread
* Presence of macrovascular invasion
* Sorafenib therapy started \> 2 months before enrolment
* Concurrent cancer, distinct from HCC (except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors)
* Previous history of any cancer, even if curatively treated, \< 5 years prior to entry
* Active intra-venous or alcohol abusers
* HIV infection
* History of serious cardiac disease
* Severe pulmonary hypertension not treatable by medical therapy
* Patients with a life expectancy of less than 3 months due to HCC or less than 6 months due to any other disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01387503
Study Brief:
Protocol Section:
NCT01387503