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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT01995227
Eligibility Criteria:
Inclusion Criteria:
* Any Patients with a diagnosis of HCC based on histology or the current accepted radiological measures.
* Age \> 18 years.
* Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.
* AFP \> 30.
* Patient who is not eligible or failed all approved HCC treatments.
Exclusion Criteria:
* Patient is unable or unwilling to sign informed consent.
* Patients that are participating in other clinical trials evaluating experimental treatments or procedures.
* Severe congestive heart failure (LVEF on echocardiogram \< 20%).
* Severe pulmonary hypertension (By echocardiogram, PAS \>45 mmHg).
* Uncontrolled diabetes mellitus (HBA1C \>9.5%).
* Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
* Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
* Patients with positive HIV1, HIV2, HTLV1, HTLV2, and RPR (syphilis).
* Women who are pregnant or breast feeding.
* Patients, based on the opinion of the investigator, should not be enrolled into this study.
* HBV DNA positive.
* If the patient is HBsAg positive or HBcAB positive, but HBV DNA negative, irrespective of his/her anti-HBS status, patient can be enrolled, but will receive preemptive therapy with Lamivudine.
* Patients with HBV DNA positive will not be enroll, but if turned negative with therapy can be enrolled. Patients with HBV and HCV will be followed by HBV DNA and HCV RNA levels during the trial.
* Any metastasis except for portal vein involvement.
* Patients with Child Pugh above B8.
* Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
* History of blood transfusion reactions.
* Known allergy to bovine or murine products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01995227
Study Brief:
Protocol Section:
NCT01995227