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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT01850368
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 20 years of age
* Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
* Eastern Cooperative Oncology Group performance status 0 or 1
* HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
* Cirrhotic status of Child Pugh class A or B7
* Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
* Patient or guardian must be able to provide verbal and written informed consent
Exclusion Criteria:
* Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
* Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
* Uncontrolled inter-current illness except liver cirrhosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01850368
Study Brief:
Protocol Section:
NCT01850368