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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03983967
Eligibility Criteria:
Inclusion Criteria:
* Patients who are more than 20 and less than 80 years old.
* Patients whose expected life expectancy is at least 16 weeks (4 months).
* Patients who receive liver transplants exceeding the Milan Criteria.
* ECOG Performance Status (ECOG-PS) score is 0-2.
* Patients who satisfy the following conditions of the blood test and kidney, liver function test.
Absolute neutrophil count \> 500x10\^6L Hemoglobin ≥ 7.5 g/dL Platelet count \> 20,000/㎣ Total bilirubin \< 15mg/㎗
•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.
Exclusion Criteria:
* Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
* Patients who undergo ABO incompatible Liver Transplantation.
* Patients who had previously administered cell therapy.
* Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
* Patients who are currently receiving dialysis.
* Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date.
* Patients who have uncontrollable or serious disease.
* Patients who are unable to use appropriate methods of contraception during the study period.
* Patient whose tumor has not been removed or liver metastasis is confirmed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT03983967
Study Brief:
Protocol Section:
NCT03983967