Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients

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