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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT01570166
Eligibility Criteria:
Inclusion Criteria:
1. age 18 - 75 years;
2. Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy);
3. no other treatment received except for the initial RFA or hepatectomy;
4. Single tumor less than 4cm in diameter;
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
6. no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -
Exclusion Criteria:
1. the presence of vascular invasion or extrahepatic spread on imaging;
2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
3. an American Society of Anesthesiologists (ASA) score ≥ 3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01570166
Study Brief:
Protocol Section:
NCT01570166