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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03170869
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation and considered for downstaging.
* Patients undergoing Surefire DEB-TACE procedure as clinically determined
* Single tumor that is \>5 cm and less than 8 cm, OR 1 to 3 tumors with combined diameter greater than 15 cm and less than 24 cm
* No portal invasion or extrahepatic spread
* No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Preserved liver function (Child-Pugh Class A or B).
* Discrete hepatic artery feeding the tumor with vessel diameter \> 1.5 mm
Exclusion Criteria:
* Advanced bilirubin levels \> 3 mg/dl
* AST or ALT\>5 upper limit of normal or \>250 U/l
* Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement)
* Contraindications for doxorubicin administration.
* Child's Class C
* Vessels providing flow to the tumor that are less than 1.5 mm in diameter
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03170869
Study Brief:
Protocol Section:
NCT03170869