Study of lenvatinib treatment benefits in patients with non-resectable liver cancer (hepatocellular carcinoma) who are on liver transplant waiting list after unsuccessful TACE therapy

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What is this study about?

This study focuses on patients with hepatocellular carcinoma (HCC), a type of liver cancer that cannot be surgically removed. The research examines the effectiveness of lenvatinib, a medication taken as hard capsules by mouth, in patients who are waiting for a liver transplantation and whose previous treatment with TACE (a procedure that delivers chemotherapy directly to liver tumors) was not completely successful.

The purpose of this research is to determine how many patients who take lenvatinib can successfully proceed to liver transplantation after their previous TACE treatment did not provide complete tumor control. The medication is designed to help control the cancer while patients are waiting for their transplant surgery.

During the study, participants will receive lenvatinib treatment and undergo regular medical evaluations to monitor their response to the medication. The research team will track how the tumors respond to the treatment and assess the safety of using lenvatinib in patients awaiting liver transplantation. They will also monitor patients after their transplant surgery to evaluate the long-term outcomes of this treatment approach.

1 Initial evaluation

Your eligibility for the trial will be confirmed through laboratory tests checking your bone marrow, liver, and kidney function

A heart test will be performed to check your QT/QTc interval which must be less than 480 ms

Your AFP score (a type of liver cancer marker) will be verified to be 2 or lower

2 Treatment initiation

You will receive Lenvima (lenvatinib) in the form of 4 mg hard capsules

The medication will be taken by mouth

You must already be registered on the national waiting list for liver transplantation

You must have previously undergone two unsuccessful TACE procedures (a type of liver cancer treatment)

3 Monitoring period

Regular imaging tests will be conducted to monitor your response to the treatment

Your condition will be evaluated using specific measurement criteria called RECIST and mRECIST

Blood tests will be performed to monitor your health status

Any side effects will be recorded and monitored

4 Liver transplantation phase

When a suitable liver becomes available, you will undergo transplantation surgery

The removed liver tissue will be examined to evaluate your response to the treatment

After transplantation, you will be monitored for any signs of cancer recurrence through imaging tests

5 Follow-up period

Regular check-ups will continue to monitor your recovery after transplantation

Imaging tests will be performed to check for any signs of cancer returning

The study will continue until August 2028

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have non-resectable liver cancer (HCC) that cannot be removed surgically
  • Must have adequate blood test results showing:
    – Hemoglobin above 8.5 g/dL
    – White blood cell count above 1500/mm3 (or 1200/mm3 for Black/African American patients)
    – Platelet count above 60,000/mm3
    – Liver and kidney function tests within specified limits
  • Must have a heart rhythm measurement (QT/QTc) less than 480 milliseconds
  • Women who can become pregnant must agree to use effective birth control for 1 month after completing treatment
  • Men with partners who can become pregnant must use effective birth control for 1 month after completing treatment
  • Must have an initial AFP score (a blood test that measures liver cancer markers) of 2 or less
  • Must be registered on the national liver transplant waiting list
  • Must have previously received TACE treatment (a procedure to block blood supply to liver tumors) but did not achieve complete response after 2 treatments
  • Must not be eligible for percutaneous ablation (a procedure using heat to destroy tumors through the skin)
  • Must provide written informed consent
  • Must have French social insurance coverage

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous or current treatment with lenvatinib (a targeted cancer medication)
  • Complete response to TACE (Transarterial chemoembolization – a procedure that blocks blood supply to liver tumors)
  • Presence of cancer that has spread outside the liver
  • Severe liver dysfunction or cirrhosis (extensive scarring of the liver)
  • Pregnancy or breastfeeding
  • Active or uncontrolled serious infections
  • Uncontrolled high blood pressure
  • History of other cancers in the past 5 years
  • Significant heart problems or recent heart attack
  • Severe bleeding disorders
  • Major surgery within the last 4 weeks
  • Current participation in other clinical trials
  • Mental conditions that prevent understanding of study requirements
  • Known allergies to study medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Crypxi Hzrjdkpplhh Rqmvdwos Urvlonntwntha Dn Tufyg Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.07.2024

Trial locations

Investigated drugs:

Lenvatinib is an oral medication used to treat liver cancer (hepatocellular carcinoma). It works by blocking certain proteins that help cancer cells grow and spread. This medication is used when other treatments, like TACE (Trans-Arterial Chemoembolization), haven’t been completely successful. It can help control tumor growth in patients who are waiting for a liver transplant.

TACE (Trans-Arterial Chemoembolization) is a medical procedure where doctors inject chemotherapy medication directly into the blood vessels that feed the liver tumor, followed by materials that block these blood vessels. This treatment aims to shrink the tumor by cutting off its blood supply while delivering chemotherapy directly to the cancer cells.

Hepatocellular Carcinoma (HCC) – A primary liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people with chronic liver diseases, such as cirrhosis. HCC usually starts as several small cancer nodules throughout the liver, rather than a single large tumor. As the disease progresses, these nodules can grow larger and spread to other parts of the liver. The condition affects liver function and can cause the organ to work less efficiently over time. Non-resectable HCC refers to tumors that cannot be completely removed through surgery due to their size, location, or number.

Trial ID:
2024-516408-40-00
Protocol code:
APHP220267
NCT ID:
NCT05901194
Trial Phase:
Human Pharmacology (Phase I) – Other

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