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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04523467
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-75
2. Unresectable HCC patients clinically diagnosed or confirmed by histopathology and/or cytology according to Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition);
3. At least one measurable lesion (according to mRECIST);
4. BCLC stage B or C (China Liver Cancer Staging \[CNLC\] IIa, IIb and IIIa);
5. The maximum diameter of a single lesion ≤10cm; No more than 10 lesions; or combined with portal vein thrombus (PVTT) type I and II (Cheng's classification);
6. Child-pugh score \<7;
7. Eastern Cooperative Oncology Group (ECOG) PS 0-1;
Exclusion Criteria:
1. Mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC) confirmed by pathology;
2. Extrahepatic metastasis;
3. Previously received hepatectomy, liver transplantation, interventional therapy, ablative therapy and other local therapies for HCC;
4. PVTT type III/IV (Cheng's classification), major hepatic vein invasion or primary to secondary bile duct invasion;
5. A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding in the past 4 weeks;
6. Cardiovascular diseases with significant clinical significance;
7. Active infection;
8. Other significant clinical and laboratory abnormalities that investigators believe affect safety evaluation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04523467
Study Brief:
Protocol Section:
NCT04523467