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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT03734068
Eligibility Criteria:
Inclusion Criteria:
* Patients with confirmed diagnosis of HCC with CT scan, MRI or biopsy
* Patient with un-resectable HCC and not indicated for other radical therapies, or waiting for transplant
* Multinodular or single nodular tumor extended to \<50% of the liver
* Hyper vascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
* At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
* No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
* Eastern Cooperative Oncology Group performance status is 0 - 1
* Proper blood, liver, renal, heart function
* Over 18 years old
* Expected survival more than 6 months
* Prior written patient consent
Exclusion Criteria:
* Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
* Tumor burden involving more than 50% of the liver
* History of biliary tract repair or endoscopic biliary tract treatment
* Clinically important refractory ascites or pleural fluid
* Any contraindications for hepatic embolization procedures
* Any contraindication for doxorubicin administration
* Contrast media allergy contraindicating angiography
* Acute or active cardiac, hepatic or renal diseases
* Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03734068
Study Brief:
Protocol Section:
NCT03734068