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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT04652492
Eligibility Criteria:
Inclusion Criteria:
1. 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
2. Histological or clinical diagnosis of HCC.
3. BCLC stage C patients ineligible for surgical resection or liver transplantation.
4. No prior systemic therapy for HCC (including immunotherapy).
5. Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
6. Child-Pugh A-B7.
7. ECOG PS 0-1.
8. Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR \> 30 ml/min/1.73 m2)
9. For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
10. life expectancy of more than 3 months.
11. Patients must be able to understand and willing to sign a written informed consent document.
12. Patients suitable for TACE therapy assessed by investigators.
Exclusion Criteria:
1. Tumor thrombus involving main trunk of portal vein or inferior vena cava.
2. Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
3. Disease history of grade 2 or more hepatic encephalopathy.
4. Extrahepatic metastasis on baseline imaging.
5. HIV infection or syphilis.
6. Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
7. Tumor diffuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04652492
Study Brief:
Protocol Section:
NCT04652492