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RECRUITING
NCT06762782
PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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: ① The subject has an intolerable toxic reaction and is still not relieved after dose adjustment; ② 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-02

Completion Date

2027-10

Last Updated

2025-01-08

Healthy Volunteers

No

Interventions

DRUG

Postoperative adjuvant lenvatinib

Follow the instructions and take lenvatinib 8 mg (body weight ≤ 60Kg) or 12 mg (body weight ≥ 60Kg) orally once a day.

OTHER

Supportive care measures

Adjuvant treatments such as antiviral, TACE, HAIC, radiotherapy, and systemic antitumor therapy can be used

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China