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Prospective, single-arm, multicenter clinical study of lenvatinib for adjuvant treatment of HCC patients with high risk of recurrence after hepatectomy.

Prospective, single-arm, multicenter clinical study of lenvatinib for adjuvant treatment of HCC patients with high risk of recurrence after hepatectomy.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034143
Enrollment
Unknown
Registered
2020-06-26
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Case series:Lenvatinib

Sponsors

Nangfan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years

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

MeasureTime frame
2-year recurrence-free survival rate;

Secondary

MeasureTime frame
2-year overall survival rate;

Countries

China

Contacts

Public ContactDinghua Yang

Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University

13600039623@163.com+86 13600039623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026