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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03145558
Eligibility Criteria:
1. Confirmed diagnosis of HCC by imaging criteria per American Association for the Study of Liver Diseases (AASLD) criteria.
2. Patients with single or multiple HCC who are unsuitable for surgical resection or RFA, but suitable for embolization.
3. ECOG score 0-1. Child-Pugh score up to B7.
4. Patients should have measurable tumor lesion(s) by contrast MRI.
5. Patients have adequate normal organ function and suitable laboratory criteria.
6. Men and women of child-bearing age need to commit to using two levels of contraception simultaneously to avoid pregnancy.
Exclusion Criteria:
1. Patients who have had a liver transplantation.
2. Patients who have uncontrolled major medical problems such as cardiac, pulmonary (COPD requiring constant oxygen), renal (creatinine over 2.0) diseases, active infectious diseases (except chronic Hepatitis B or C), or non-healing ulceration.
3. Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room air.
4. Patients with evidence of arterial insufficiency or microangiopathy in any organ due to any reason, which could lead to distal extremity hypoxia, as evidenced by any gangrenous change in distal limbs or requiring resection for this reason.
5. Patients with poorly controlled HBV infection.
6. Patients on interferon treatment need to have at least 2-week washout period from Day 1.
7. Patients with major gastrointestinal bleeding in the prior 2 months of enrollment or known diagnosis of cancer other than HCC.
8. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03145558
Study Brief:
Protocol Section:
NCT03145558