Study on Lenvatinib for Treating Recurrent Liver Cancer After a Liver Transplant

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05103904

Provider View

This clinical trial is testing the drug lenvatinib to see if it can help treat liver cancer that has returned after a liver transplant. The study aims to find out if lenvatinib can stop the growth of cancer cells in patients who have limited treatment options.

Patient Parameters

Program Overview

This study is exploring the use of lenvatinib, a medication that may block the growth of liver cancer cells, in patients whose liver cancer has come back after a liver transplant. Liver cancer is a serious disease, and while a liver transplant can be a cure, some patients experience a return of the cancer. Currently, there are no established treatments for these patients, so this study aims to see if lenvatinib can be effective in controlling the cancer.

Description

The main goal of this study is to see how well lenvatinib works in shrinking tumors in patients with recurrent liver cancer after a liver transplant. Researchers will measure the overall response rate to the treatment using specific criteria.

Secondary goals include evaluating the safety and side effects of lenvatinib, as well as how long patients live without the cancer getting worse and their overall survival time.

The study will also look at how lenvatinib affects cancer cells and certain markers in the blood.

Participants will take lenvatinib by mouth once a day. The treatment will continue every 28 days as long as the cancer does not progress, there are no severe side effects, and the patient chooses to stay in the study.

After finishing the treatment, patients will be monitored for 30 days and then every 90 days for up to two years or until they pass away.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 and older.
  • Must have liver cancer that has returned after a liver transplant and cannot be removed by surgery.
  • Good overall health with a performance status score of 0 or 1.
  • Child Pugh class A liver function.
  • Previous liver transplant for curing liver cancer.
  • Cancer must be measurable by specific criteria.
  • Expected to live more than 12 weeks.
  • Adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 60 days after.
  • Men must also agree to use effective birth control during the study and for 60 days after.
  • Patients with heart disease must have a certain level of heart function.
  • Willing to follow study procedures and attend scheduled visits.
  • Must sign an informed consent form acknowledging understanding of the study and its potential risks and benefits.

Exclusion Criteria

  • Previous treatment with lenvatinib or similar drugs for liver cancer after a transplant.
  • Recent liver-directed therapy unless it was more than 28 days ago.
  • Recent radiotherapy or unresolved side effects from previous treatments.
  • Participation in another clinical trial or use of investigational drugs within 21 days before starting this study.
  • Allergic reactions to lenvatinib or similar drugs.
  • Known brain metastases.
  • Uncontrolled illnesses or infections.
  • Significant heart problems or recent heart attack or stroke.
  • Uncontrolled high blood pressure.
  • Bleeding disorders or risk of severe bleeding.
  • High levels of protein in urine unless confirmed to be low by a 24-hour urine test.
  • Not fully recovered from previous cancer treatments or surgery.
  • Pregnant or breastfeeding women.
  • Severe allergy to lenvatinib or its ingredients.
  • Known HIV infection.
  • Recent diagnosis or treatment of another cancer within the last two years, except for certain skin or cervical cancers.

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