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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03535259
Eligibility Criteria:
Inclusion Criteria:
1. Clinical or histologic diagnosis of Hepatocellular carcinoma (HCC)
2. Aged between 18 and 80 years
3. ECOG 0-1
4. Liver-GTV\>700ml
5. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning)
6. Estimated life expectancy \> 3 months
7. Child-Pugh Score: A5-B8
8. Hepatic function: alanine transaminase (ALT) and aspartate transaminase (AST)≤ 1.5 times ULN; or ALT ≤ ULN and AST≤ 6 times ULN exclude possibility of heart disease
9. Renal function: creatinine (CRE) and blood urea nitrogen (BUN)≤ 1.5 times ULN
10. Blood routine examination: Hb≥80g/L, ANC≥1.0×109 /L, PLT≥40×109 /L
11. Voluntary to participate and sign informed consent
Exclusion Criteria:
1. Had prior abdominal irradiation
2. Had prior liver transplantation
3. Had serious myocardial disease or renal failure
4. Pregnant, breast feeding, or unwilling to use adequate contraception
5. Known hypersensitivity to sorafenib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03535259
Study Brief:
Protocol Section:
NCT03535259