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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT06492395
Eligibility Criteria:
Inclusion Criteria:
* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
* life expectancy of at least 3 months
Exclusion Criteria:
* Diffuse HCC
* accompanied with vena cava tumor thrombus
* central nervous system involvement
* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
* history of other malignancies
* uncontrollable infection
* history of HIV
* history of organ or cells transplantation
* prothrombin time prolongation \>4 s
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06492395
Study Brief:
Protocol Section:
NCT06492395