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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02584556
Eligibility Criteria:
Inclusion Criteria:
1. a preoperative diagnosis of HCC with no previous treatment;
2. compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
3. multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation;
4. on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation.
5. Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin\<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction\_lower limit of normal for the institution. Patients with AST and ALT\<5 ×ULN could be recruited if total bilirubin was in the normal range.
Exclusion Criteria:
1. documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
2. concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
3. CNS metastasis;
4. Other serious illness or medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02584556
Study Brief:
Protocol Section:
NCT02584556