Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery

• Status: RECRUITING
• Trial end date: 2027-10-01

Summary

This study is a prospective, randomized, controlled, open, phase II, multicenter clinical study, which aims to evaluate the efficacy and safety of lenvatinib for adjuvant treatment of high-risk recurrent liver cancer after radical surgery.

This study is divided into 3 stages: screening period (screening period 28 days), treatment period (up to 12 months, or until any of the following occurs, whichever occurs first: The subject has an intolerable toxic reaction and is still not relieved after dose adjustment; The subject's first imaging confirmed disease recurrence or withdrew from the study for other reasons), and follow-up period (12 months after the end of treatment).

Dosage regimen:

Eligible subjects were randomly assigned to the experimental group or the control group in a 2:1 ratio, with surgical method (radical surgery vs ablation) as the stratification factor. The experimental group received lenvatinib treatment, and the control group received best supportive care

• Phase: PHASE2

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Affiliated Hospital of Nantong University; Huai'an First People's Hospital; Jiangsu Taizhou People's Hospital; Northern Jiangsu People's Hospital; Suzhou Municipal Hospital; The Affiliated Hospital of Xuzhou Medical University; The First People's Hospital of Changzhou; The First People's Hospital of Lianyungang; Xuzhou Central Hospital; Zhongda Hospital