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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT06588569
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 and 75 years, gender not specified;
2. Pathologically confirmed primary liver cancer or colorectal cancer liver metastases, which is unresectable, intolerant to surgical resection, or refused surgical resection;
3. Intrahepatic lesions with a diameter of ≤4cm, and the number of lesions ≤3.;
4. At least 3 months since the last systemic treatment and at least 1 month since the last local treatment;
5. Child-Pugh class A or B;
6. ECOG PS ≤ 2.
Exclusion Criteria:
1. Liver function Child-Pugh class C , severe jaundice, especially obstructive jaundice;
2. Diffuse liver cancer, or with tumor thrombi in the main portal vein to secondary branches or hepatic vein;
3. Significant liver atrophy, tumor volume too large, requiring ablation range of up to one-third of the liver volume;
4. Multiple systemic metastases, expected survival \< 3 months;
5. Recent history of esophageal (gastric fundus) variceal bleeding within the past month;
6. Severe functional failure of major organs such as the liver, kidneys, heart, lungs or brain;
7. Presence of active infection;
8. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a significant bleeding tendency;
9. Refractory massive ascites, pleural effusion, or cachexia;
10. Pregnancy, disorder or inability to cooperate with treatment;
11. Any other factors deemed inappropriate for inclusion or affecting the subject's participation in the study, as determined by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06588569
Study Brief:
Protocol Section:
NCT06588569