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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05992220
Eligibility Criteria:
Inclusion Criteria:
* Older than 19 years of age, lower than 80 years of age
* Child-Pugh class A hepatic function
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
* Patients with HCC \[diagnosed according to AASLD guidelines\] invading the intrahepatic vascular system
* No prior systemic therapy for HCC
* At least one measurable HCC lesion with ≥ 1cm diameter
* Adequate hematologic and organ function
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1,000 /mm3
* Platelet ≥ 50,000/ mm3 without transfusion
* Total bilirubin ≤ 2.5 mg/dL
Exclusion Criteria:
* Treatment history of prior systemic treatment of HCC
* Liver transplant recipients
* Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding
* Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity
* A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years
* Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT05992220
Study Brief:
Protocol Section:
NCT05992220