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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT06210334
Eligibility Criteria:
Inclusion Criteria:
1. Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC).
2. Age between 18 and 75 years.
3. Presence of type 4 portal vein tumor thrombosis (PVTT).
4. Child-Pugh A or B liver function.
5. Eastern Cooperative Group performance status (ECOG) score of 0-2.
6. Satisfactory blood, liver, and kidney function parameters, including:
* (a) Hemoglobin concentration ≥ 8.5 g/dL, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 40 × 10\^9/L.
* (b) Serum albumin concentration ≥ 30 g/L, bilirubin ≤ 50 μmol/L, AST and ALT \< 5 × upper limit of normal (ULN), and alkaline phosphatase \< 4 × ULN.
* (c) Extended prothrombin time \< 6 seconds of ULN.
* (d) Serum creatinine \< 1.5 × ULN.
7. Ability to comprehend the protocol and provide informed consent by signing a written document.
Exclusion Criteria:
1. History of a second primary malignant tumor.
2. Severe dysfunction of the heart, kidneys, or other organs.
3. Evidence of hepatic decompensation, including ascites, active gastrointestinal bleeding, or hepatic encephalopathy.
4. Pregnancy or lactation.
5. Known history of HIV.
6. History of organ allograft.
7. Known or suspected allergy to investigational agents or any agent administered in conjunction with this trial.
8. Active gastric or duodenal ulcers within 3 months before enrollment.
9. Incomplete medical data or loss to follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06210334
Study Brief:
Protocol Section:
NCT06210334