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 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT06819566
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 19 years or older and under 80 years.
* Patients with liver function are classified as Child-Pugh Class A.
* Barcelona Clinic Liver Cancer stage C patients with no prior systemic anticancer therapy for hepatocellular carcinoma.
* Patients with an Eastern Cooperative Oncology Group performance score of 0-1.
* Adequate Hematologic and Liver Function:
A. Hemoglobin: ≥ 9.0 g/dL B. Absolute Neutrophil Count : ≥ 1,000/mm³ C. Platelet Count: ≥ 70,000/μL D. Prothrombin Time: ≥ 70% (or Prothrombin Time INR ≤ 1.2)
* Patients with upper gastrointestinal endoscopy performed within six months prior to the start of anticancer treatment.
* No plans for breastfeeding, and if of childbearing potential, using contraception or no plans for spouse's pregnancy or practicing contraception.
* Patients who have received an explanation of the treatment purpose and methods and have provided informed consent for the treatment.
Exclusion Criteria:
* Participants who have previously received systemic anticancer therapy for advanced hepatocellular carcinoma.
* Patients with intrahepatic tumor involvement of 50% or more.
* Patients with tumor thrombus in the main portal vein or both first-order branches (Vp4).
* Patients with a prior history of liver transplantation.
* with uncontrolled malignant tumors other than HCC at the time of enrollment (participation is allowed if disease-free survival exceeds two years).
* Patients with uncontrolled or serious underlying diseases requiring treatment.
* Patients with a history of esophageal or gastric variceal bleeding.
* Previous Variceal Treatments: Patients who have undergone any of the following treatments for variceal bleeding:
A. Endoscopic Variceal Obliteration (EVO) B. EVL C. Transjugular Intrahepatic Portosystemic Shunt (TIPS) D. Percutaneous Approach for Retrograde Transvenous Obliteration (PARTO) E. Surgical procedures
* Patients who have used anticoagulants or antiplatelet agents within one week prior to the study.
* Presence of grade 2 or higher isolated gastric varices or Red Color Signs confirmed by baseline endoscopy (EGD).
* Patients who are pregnant.
* Patients who are unable to understand or provide written informed consent.
* Patients deemed unsuitable for clinical study participation based on the investigator's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06819566
Study Brief:
Protocol Section:
NCT06819566