Lenvatinib + TACE for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of lenvatinib, a cancer drug, and a procedure called transcatheter arterial chemoembolization (TACE) to determine if they can better prepare patients with liver cancer for a transplant. The focus is on patients with hepatocellular carcinoma (HCC) that doesn't meet the typical transplant criteria. The trial will compare results with patients who have already undergone a transplant under similar conditions. Suitable candidates have liver cancer beyond the usual transplant criteria, have not received prior treatment, and are on the liver transplant waiting list. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have hepatitis B or C, you must continue antiviral therapy while on the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using lenvatinib with TACE, a liver cancer treatment, is generally safe. In studies with liver cancer patients, this combination proved more effective than TACE alone. Patients tolerated it well, and side effects were typical for cancer treatments. Some changes in liver function occurred, but they were not serious. These results suggest a positive safety outlook for using lenvatinib with TACE.12345
Why do researchers think this study treatment might be promising for liver cancer?
Researchers are excited about combining lenvatinib with Transcatheter Arterial Chemoembolization (TACE) for liver cancer because this approach offers a novel way to tackle tumors. While standard treatments like surgery or systemic therapies focus on removing or shrinking tumors, lenvatinib is an oral medication that targets specific growth factors involved in tumor development, potentially slowing cancer progression more effectively. When paired with TACE, which directly delivers chemotherapy to the liver, this combination could enhance the treatment's ability to control liver tumors, offering new hope for patients with hepatocellular carcinoma beyond traditional criteria for transplant eligibility.
What evidence suggests that lenvatinib in combination with TACE might be an effective treatment for liver cancer?
Research has shown that using lenvatinib with transcatheter arterial chemoembolization (TACE) may be promising for treating liver cancer. In this trial, participants will receive a six-month regimen of neoadjuvant lenvatinib combined with TACE before liver transplantation. One study found that this combination effectively managed liver cancer in patients unsuitable for a transplant. Patients who received both treatments experienced noticeable tumor shrinkage. Another study observed that starting TACE early, along with lenvatinib, led to better results than using lenvatinib alone. Overall, these findings suggest that this combined treatment could be an effective option for liver cancer.12567
Who Is on the Research Team?
Maen Abdelrahim, MD
Principal Investigator
The Methodist Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with advanced liver cancer (HCC) who haven't had previous cancer treatments, are on the liver transplant list, and can perform daily activities with little to no assistance. They must have well-managed hepatitis if present, good organ function, not be pregnant or breastfeeding, and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive a six-month regimen of lenvatinib in combination with TACE prior to liver transplantation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Transplantation and Post-Transplant Follow-up
Participants undergo liver transplantation and are monitored for outcomes such as tumor necrosis and survival
What Are the Treatments Tested in This Trial?
Interventions
- Lenvatinib
- Transcatheter Arterial Chemoembolization
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Eisai Inc.
Industry Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University