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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT02748161
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older, inclusive
* Diagnosis of HCC
* Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
* No portal invasion or extrahepatic spread on imaging.
* Child-Pugh Class A or B.
* No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.
Exclusion Criteria:
* Bilirubin levels greater than 3 mg/dl
* AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
* Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement).
* Contraindications for doxorubicin administration.
* Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
* Unable or unwilling to provide informed consent.
* Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
* Women who are pregnant or breast feeding.
* Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
* Portal vein thrombosis of bland or malignant origin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02748161
Study Brief:
Protocol Section:
NCT02748161