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RecruitingPhase 2NCT06762782

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

Enrollment

276 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether lenvatinib (a targeted therapy drug) can reduce the chance of liver cancer coming back after surgery in patients who had a high-risk liver cancer resection. The drug is being given after surgery as "adjuvant" (preventive) therapy. **You may be eligible if...** - You are between 18 and 80 years old - You had surgery to remove liver cancer (hepatocellular carcinoma) 4 to 8 weeks before joining the study - The surgery removed the tumor completely with clear margins - The cancer had not spread to other organs at the time of surgery - Your post-surgery imaging shows no visible remaining tumor **You may NOT be eligible if...** - You had an incomplete tumor removal (positive surgical margins) - The cancer had already spread to lymph nodes or distant organs - There was tumor growth into major blood vessels at the time of surgery - You have organ function that does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPostoperative adjuvant lenvatinib

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

OTHERSupportive 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

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NCT06762782

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