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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT06397235
Eligibility Criteria:
Inclusion Criteria:
* HCC confirmed by histology/cytology or diagnosed clinically.
* At least one measurable intrahepatic target lesion.
* The largest tumor size \> 7 cm.
* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
* Child-Pugh score 5-7.
* ECOG performance status ≤ 1.
* Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.
Exclusion Criteria:
* Macrovascular invasion or extrahepatic metastasis.
* Diffuse HCC.
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
* Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
* History of other malignancies.
* Uncontrollable infection.
* History of HIV.
* Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
* History of organ or cells transplantation.
* Pregnant or lactating patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06397235
Study Brief:
Protocol Section:
NCT06397235