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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT05489692
Eligibility Criteria:
Inclusion Criteria:
1. Patients were initially diagnosed without any previous oncological treatment.
2. The tumor was assessed as unresectable by two hepatobiliary surgeons (BL and YY, with more than 15 years of experience). Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
3. At least one assessable intrahepatic lesion.
4. classified as Child-Pugh Grade A.
5. ECOG PS score 0-1.
6. baseline blood tests meet the following criteria: leukocytes ≥3.0×10\^9/L; neutrophils ≥1.5×10\^9/L; platelets ≥75×10\^9/L; hemoglobin ≥ 80g/L; serum ALT or AST ≤ 3 times of upper limit of normal (ULN); serum creatinine ≤1.5 x ULN; INR ≤ 1.5, or prothrombin time ≤ ULN + 4 seconds; albumin ≥ 30 g/L; total bilirubin ≤ 3 x ULN.
Exclusion Criteria:
1. severe underlying cardiac, pulmonary, or renal diseases.
2. a second primary malignancy.
3. prior history of organ transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05489692
Study Brief:
Protocol Section:
NCT05489692