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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT05021250
Eligibility Criteria:
Inclusion Criteria:
1. Clinically or pathologically confirmed hepatocellular carcinoma.
2. ECOG 0-1.
3. BCLC C
4. Liver-GTV \>700ml; intrahepatic metastasis allowed but only one tumor is to be treated with SBRT and others stable for more than 3 months; distant metastasis allowed but stable for more than 6 months.
5. Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f.
6. DIBH training prior to SBRT to achieve 36 seconds breath hold.
7. Life expectancy \> 3 months.
8. Child-Pugh A5, A6 or B7.
9. Liver function: ALT within 1.5 times of upper limit; ALT within 0.5 times of upper limit and AST within 6 times of upper limit, excluding cardiac infarction; ALT within 0.5-1.5 times of upper limit and AST within 1.5 times of upper limit
10. Normal ECG, without severe cardiac dysfunction
11. Kidney function: CRE, BUN within 1.5 times of upper limit.
12. CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L
13. Without hemorrhagic tendency.
14. Voluntarily participate in this trial and sign consent form.
Exclusion Criteria:
1. Participants of other clinical trials.
2. History of abdomen radiation therapy or liver transplantation.
3. History of severe cardiovascular, kidney or liver disease.
4. Pregnancy or lactation.
5. Suspected or confirmed of drug or alcohol abuse.
6. History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis.
7. Allergic to lipiodol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05021250
Study Brief:
Protocol Section:
NCT05021250