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:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT06487559
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced or metastatic and/or unresectable HCC
* Child-Pugh A
* Barcelona Clinic Liver Cancer stage B or C
* Eastern Cooperative Oncology Group (ECOG) Perfromance Status of 0-1
* Received an immune checkpoint inhibitor in 1L HCC treatment regimen
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.
* History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%).
* History of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis
* History of clinically significant conditions such as but not limited to the following: renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that in Investigator's opinion, would adversely affect the subject's participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06487559
Study Brief:
Protocol Section:
NCT06487559