Study on Lenvatinib and TACE Combination Therapy Before Liver Transplant for Large Liver Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0

ClinicalTrials ID:NCT05171335

Provider View

This clinical trial is exploring whether a combination of the drug lenvatinib and a procedure called TACE can help control large liver tumors in patients waiting for a liver transplant. The study will compare results with past cases to see if this approach improves outcomes.

Patient Parameters

Program Overview

The study aims to find out if using lenvatinib along with transcatheter arterial chemoembolization (TACE) for six months before a liver transplant can help manage large liver tumors in patients who are eligible for a transplant. Researchers will compare the results to previous cases to see if this combination therapy is more effective.

Description

Liver cancer is a major cause of cancer deaths worldwide. This study focuses on patients with large liver tumors who are waiting for a liver transplant. The goal is to see if a combination of lenvatinib, a medication that targets cancer growth, and TACE, a procedure that cuts off the tumor's blood supply, can improve outcomes. TACE is already used to stabilize tumors while patients wait for a transplant, but it can sometimes lead to incomplete tumor destruction. Lenvatinib may enhance the effects of TACE by preventing new blood vessel growth that tumors need to survive. This study will evaluate if this combination can better control tumor growth, reduce the risk of being removed from the transplant list, and improve survival rates after transplantation. Participants will receive lenvatinib and TACE before their transplant, and their progress will be compared to past patients who did not receive this combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed large liver cancer that exceeds standard transplant criteria.
  • Must not have received prior treatment and be eligible for the TACE procedure.
  • Must be on the liver transplant waiting list and not need any other organ transplant.
  • Must be in good general health with a performance status of 0 or 1.
  • Patients with hepatitis B or C must be on antiviral therapy during the study.
  • Women of childbearing potential must use effective birth control before and during the study.
  • Men must use condoms or other effective birth control methods during treatment.
  • Must have adequate organ function, including specific blood counts and heart function.
  • Must be able to take oral medication and agree to follow the study protocol.

Exclusion Criteria

  • Have a different type of liver cancer or meet standard transplant criteria.
  • Have received previous chemotherapy or immunotherapy for liver cancer.
  • Have severe liver disease or uncontrolled high blood pressure.
  • Have significant heart problems or recent heart attack or stroke.
  • Have bleeding disorders or risk of severe bleeding.
  • Have protein in urine above a certain level.
  • Have blood clots in the liver that prevent TACE.
  • Have another active cancer or infection.
  • Are pregnant, breastfeeding, or not willing to use birth control during the study.
  • Have an allergy to lenvatinib or its ingredients.

Locations

FACILITYZIPCITYSTATE
Houston Methodist Research Institute77030HoustonTexas

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