NCT04227808

Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma

Safety and Efficacy of Lenvatinib as an Adjuvant Therapy in Patients With Hepatocellular Carcinoma Following Radical Resection: A Single-Arm and Open-Label Prospective Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of HCC with a high risk of tumor recurrence. Investigator hypothesize that lenvatinib may be an effective adjuvant treatment for HCC, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (RFS) of HCC patients after surgical resection.

Detailed description

There's no widely accepted adjuvant therapy for patients with HCC. Lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved for advanced or unresectable HCC. In this study, investigators aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent curative resection for HCC with high risk of disease recurrence. Participants who underwent radical resection for HCC with high risk of tumor recurrence will be recruited in this study. During 4 to 6 weeks after surgery, each participant will receive a screening visit to exclude residual tumors. Each eligible participant will be treated with lenvatinib until tumor recurrence, intolerant adverse effect, participant' refusal, or completing 12-month treatment.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Lenvima 4 mg Oral Capsule	The participants will receive treatment with lenvatinib for 12 months after recruitment or until disease recurrence, intolerance AEs, or death. In case of treatment-related adverse effects, interruption or reduction is allowed.

Timeline

• Start date: 2019-12-12
• Primary completion: 2021-12-30
• Completion: 2022-02-28
• First posted: 2020-01-14
• Last updated: 2020-01-14

Locations

4 sites across 1 country: China