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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01923233
Eligibility Criteria:
Inclusion Criteria:
1. Any patients with a diagnosis of HCC based on histology or the current accepted radiological measures.
2. Age \> 18 years.
3. Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.
4. AFP \>30.
5. Patient who is not eligible for or failed any HCC treatment.
Exclusion Criteria:
1. Patient is unable or unwilling to sign informed consent.
2. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
3. Severe congestive heart failure (LVEF on echocardiogram \< 20%).
4. Severe pulmonary hypertension (By echocardiogram, PAS \>45 mmHg).
5. Uncontrolled diabetes mellitus (HBA1C \>9.5%).
6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
7. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
8. Subjects with positive HIV.
9. Women who are pregnant or breast feeding.
10. Patient, based on the opinion of the investigator, should not be enrolled into this study.
11. HBsAg positive or HBV DNA positive.
12. If the patient is HBcAB positive but HBsAG negative, irrespective of his anti HBS status, he can be enrolled but will receive preemptive therapy with Lamivudine.
13. Any metastasis except for portal vein involvement.
14. Subjects with Child Pugh above B8.
15. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
16. History of blood transfusion reactions.
17. Known allergy to bovine or murine products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01923233
Study Brief:
Protocol Section:
NCT01923233