Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, male or female; 2. Have not received other anti-tumor treatment before surgery; 3. Patients with hepatocellular carcinoma who have been surgically removed and confirmed by pathology; 4. Postoperative pathology indicates that there is no residual margin, and 3 to 7 weeks after surgery, imaging confirms complete remission; 5. Preoperative imaging (CT/MRI/PET-CT), intraoperative or postoperative pathological examinations suggest that there is at least one high-risk factor for recurrence: (1) Number of tumors >=3; (2) The degree of differentiation is grade IV (using Edmondson-Steiner classification method); (3) Hepatic veins, portal veins, bile ducts, or inferior vena cava can be visually or microscopically seen with tumor thrombi, and the tumor and tumor thrombus can be surgically removed;? Preoperative AFP increased (>=200 ng/ml), AFP still >=200 ng/ml 1 to 2 months after surgery;? Tumor rupture; (4) There is no clear fibrous envelope or incomplete envelope between the tumor and liver tissue; (5) See the satellite nodules on the excised specimen. 6. The function of major organs is normal, and Child-Pugh liver function rating: Grade A or better Grade B (<=7 points); 7. ECOG PS score within 1 week before enrollment 0~1; 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with recurrent hepatocellular carcinoma;(2) Patients who are preparing for liver transplantation (included on the transplant list);(3) Those who have been confirmed to be allergic to lenvatinib mesylate capsules and/or their accessories;(4) Pregnant or lactating women;(5) Patients with contraindications to lenvatinib;(6) Those who the doctor thinks are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate; | — |
Countries
China
Contacts
Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University