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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01489566
Eligibility Criteria:
Perioperative Period Inclusion Criteria
1. Signed informed consent;
2. Aged ≥ 18 years and ≤ 75 years old, male or female；
3. Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
4. The tumor characteristics must meet one of the following:
* Tumor thrombosis in the portal vein branches is detected by either;
* Preoperative imaging, or;
* Intraoperative visual observation.
* Tumor thrombosis in the portal vein branches was not detected; and
* A single tumor with a maximum diameter ≥8cm confirmed by preoperative imaging, and histological evidence of micro vascular tumor thrombosis; or
* Preoperative imaging confirmed that there are 2 or more tumor lesions
Perioperative Period Exclusion Criteria
1. Concomitant malignant primary tumor(s) in other systems is/are present;
2. Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery;
3. The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy;
4. The subject took other study/investigational drugs 7 days prior to the resection surgery;
5. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
6. The subject has history of study drug or similar drug allergy
Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria
1. Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;
2. Child-Pugh score of class A at baseline
Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria
1. Body surface area is \< 1.47 m2 or \> 1.92 m2;
2. Concomitant malignant primary tumor(s) in other systems is/are present;
3. The subject took other study/investigational drugs within 4 weeks prior to randomization;
4. The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
5. The baseline examination suggests the presence of tumor metastasis;
6. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
7. The subject has history of investigational drug or similar drug allergy;
8. The subject is pregnant, lactating, or urine pregnancy test result is positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01489566
Study Brief:
Protocol Section:
NCT01489566