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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05875558
Eligibility Criteria:
Inclusion Criteria:
1. 18≤Age\<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.
4. Have a Child-Pugh Class A/B（\<7） liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.
Exclusion Criteria:
1. The targeted lesions have received TACE or other locoregional therapy within 3 months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min.
6. Severe heart, lung or cerebral disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05875558
Study Brief:
Protocol Section:
NCT05875558