Lenvatinib for Recurrent Liver Cancer Post-Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates lenvatinib for treating hepatocellular carcinoma (HCC) that has returned after a liver transplant. Lenvatinib blocks certain enzymes that promote cancer cell growth. Currently, no standard treatment exists for this condition, so the trial aims to determine lenvatinib's effectiveness. Individuals who have had a liver transplant and face a recurrence of liver cancer that cannot be surgically removed might be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you should not be on any other investigational agents or have had certain treatments recently. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that lenvatinib is likely to be safe for humans?
Research shows that lenvatinib is generally well-tolerated by patients with liver cancer. In studies involving individuals whose liver cancer returned after a liver transplant, lenvatinib proved to be safe. Although some side effects occurred, they were mostly manageable. This drug already has approval for other types of liver cancer, indicating a history of safety. However, as this is a phase II study, more information is needed to fully understand its safety for this specific use. It's important to remember that reactions vary, so some people might experience more side effects than others.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about lenvatinib for recurrent liver cancer post-transplant because it offers a novel angle of attack against the disease. Unlike standard treatments like immunosuppressive therapy, lenvatinib is a targeted therapy that inhibits specific proteins called tyrosine kinases, which are involved in tumor growth and blood supply. This mechanism can potentially slow cancer progression more effectively. Additionally, lenvatinib is taken orally, making it a convenient option compared to some existing treatments that require intravenous administration. These unique features position lenvatinib as a promising candidate in the ongoing search for better liver cancer treatments post-transplant.
What evidence suggests that lenvatinib might be an effective treatment for recurrent liver cancer?
Research has shown that lenvatinib, the treatment under study in this trial, can effectively treat liver cancer that returns after a transplant. In one study, about 20% of patients experienced tumor shrinkage with lenvatinib, meaning one in five patients saw improvement. Another study suggested that lenvatinib might be safer and just as effective as sorafenib, another drug for this cancer type, potentially leading to better survival rates. Additionally, lenvatinib might lower the risk of cancer returning in people with certain risk factors, such as having multiple tumors or tumors that differ significantly from normal cells. While more research is needed, these findings suggest lenvatinib could be a promising option for liver cancer that recurs after a transplant.23567
Who Is on the Research Team?
Olumide Gbolahan
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Are You a Good Fit for This Trial?
Adults with recurrent hepatocellular carcinoma after liver transplant, who are in good physical condition (ECOG <=1), have measurable disease, and a life expectancy over 12 weeks. They must not be planning surgery, have brain metastases or uncontrolled illnesses like heart failure. Participants need normal organ function tests and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenvatinib orally once daily. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the protocol therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 90 days until death or 2 years from registration.
What Are the Treatments Tested in This Trial?
Interventions
- Lenvatinib
Lenvatinib is already approved in United States, European Union for the following indications:
- Differentiated Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Renal Cell Carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Eisai Co., Ltd.
Industry Sponsor
Lynn Kramer
Eisai Co., Ltd.
Chief Medical Officer since 2019
MD from the University of Tokyo
Haruo Naito
Eisai Co., Ltd.
Chief Executive Officer since 1988
Bachelor's degree in Economics from Keio University