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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03998033
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent obtained prior to study procedures
* Histologically confirmed HCC with serum AFP \>200ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \>400ng/ml at time of screening and following most current line of therapy..
* Metastatic or locally advanced, unresectable HCC
* Must have failed or not tolerated, at least one line of systemic therapy for advanced HCC
* Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
* Life expectancy of at least 4 months
* Karnofsky Performance Scale greater than or equal to 70
* At least 1 measurable lesion on imaging by RECIST
* Child-Pugh A or B7
* Absolute neutrophil count greater than or equal to 1,500/mm\^3
* Platelet count greater than or equal to 30,000/mm\^3
Exclusion Criteria:
* Clinically significant cardiac disease
* Clinically significant pre-existing illness or active infection
* Clinically significant Central Nervous System (CNS) or neural dysfunction
* Active autoimmune disease requiring therapy
* Active malignancy other than HCC unless expected survival is greater than or equal to three years without any treatment (exception: hormone/androgen-depravation therapy) and without any organ involvement
* History of organ transplant
* Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
* Advanced HCC involving greater than one-third of the liver
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03998033
Study Brief:
Protocol Section:
NCT03998033