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

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

Conditions

• Hepatocellular Carcinoma (HCC)
• Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) At High Risk of Recurrence After Curative Resection or Ablation

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

Sponsors & Collaborators

• The First People's Hospital of Changzhou

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• Jiangsu Taizhou People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-28

Primary Completion

2027-10-31

Completion

2027-10-31

Countries

• China

Study Locations