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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06796803
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent Form (ICF)
2. Aged ≥18 years and ≤75 years at time of signing ICF
3. Documented diagnosis of HCC confirmed by histology/cytology or clinically
4. Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
5. At least one measurable lesion (per RECIST v1.1) untreated lesion
6. ECOG performance status of 0 or 1
7. Child-Pugh ≤7 score
8. Life expectancy ≥12 weeks
9. Adequate organ function
10. No prior anti-tumor systemic therapies for HCC
Exclusion Criteria:
1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Other active malignant tumor except HCC within 5 years or simultaneously
3. Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
4. There is an absolute contraindication to HAIC
5. History of hepatic encephalopathy
6. Diffuse HCC, intrahepatic tumor burden \> 50%
7. PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
8. Clinically significant ascites
9. Prior allogeneic stem cell or solid organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06796803
Study Brief:
Protocol Section:
NCT06796803