Not recruiting

Study on Cabozantinib for Patients with Liver Cancer Not Responding to Previous Immune Treatments

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a medication called Cabozantinib in patients with a type of liver cancer known as Hepatocellular Carcinoma. This study is specifically for patients whose cancer has continued to grow or who cannot tolerate previous treatments with immune checkpoint inhibitors, which are drugs that help the immune system fight cancer.

The purpose of the study is to evaluate how well Cabozantinib works as a second or third treatment option for these patients. Participants in the study will take Cabozantinib in the form of film-coated tablets, which are taken by mouth. The study will compare the effects of different doses of the medication, including 20 mg, 40 mg, and 60 mg tablets. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment and to check for any side effects. The study aims to provide valuable information on the potential benefits and risks of using Cabozantinib for treating Hepatocellular Carcinoma in patients who have limited treatment options. The study is expected to continue until the end of 2025.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, you will begin treatment with a medication called cabozantinib. This medication is provided in the form of film-coated tablets, which you will take by mouth.
The dosage of cabozantinib will be determined by your healthcare provider, and it may include 20 mg, 40 mg, or 60 mg tablets. The specific dosage and frequency will be tailored to your individual needs and medical condition.
Step 2
Treatment schedule
You will take the cabozantinib tablets once daily. It is important to follow the instructions provided by your healthcare provider regarding the timing and method of taking the medication.
The duration of the treatment will be determined by your response to the medication and any side effects you may experience. Regular assessments will be conducted to monitor your progress.
Step 3
Monitoring and assessments
Throughout the trial, you will undergo regular medical assessments to evaluate the effectiveness of the treatment and monitor for any side effects. These assessments may include physical examinations, blood tests, and imaging studies.
Your healthcare provider will discuss the results of these assessments with you and make any necessary adjustments to your treatment plan.
Step 4
End of treatment
The treatment with cabozantinib will continue until the end of the study period or until your healthcare provider determines that it is appropriate to stop the medication.
After completing the treatment, you may be asked to return for follow-up visits to assess your overall health and any long-term effects of the medication.

Who can join the trial?

17 criteria

Must have a confirmed diagnosis of Hepatocellular carcinoma (HCC), which is a type of liver cancer.
Must have a Child-Pugh Score of A, which is a measure of liver function.
Total bilirubin level must be 2 mg/dL or less within 7 days before starting treatment. Bilirubin is a substance made by the liver.
Serum albumin level must be 2.8 g/dL or more within 7 days before starting treatment. Albumin is a protein in the blood.
ALT and AST levels must be 5 times the upper limit of normal or less. These are enzymes that show liver health.
If there is an active hepatitis B (HBV) infection, antiviral therapy must be given according to local standards.
Must be able to understand and follow the study requirements and sign a consent form.
Sexually active participants and their partners must agree to use medically accepted methods of contraception during the study and for 4 months after the last dose.
Women who can become pregnant must not be pregnant at the start of the study.
A new tumor tissue sample is optional at screening, but the patient must have a disease site that can be biopsied if needed.
The disease must not be treatable with local methods like transplant, surgery, or other specific procedures.
Must have shown disease progression after 1 or 2 previous treatments for advanced disease, including immune checkpoint inhibitors, or have had to stop treatment due to immune-related issues.
Must have recovered to Grade 1 or better from any side effects of previous treatments, unless they are not significant or are stable with supportive care.
Must be at least 18 years old on the day of giving consent.
Must have an ECOG performance status of 0 or 1, which measures daily living abilities.
Must have adequate blood function, shown by specific levels of neutrophils, platelets, and hemoglobin within 7 days before starting treatment.
Must have adequate kidney function, shown by specific levels of serum creatinine or creatinine clearance.

Who cannot join the trial?

5 criteria

Patients who do not have hepatocellular carcinoma (a type of liver cancer) cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are not eligible for second- or third-line treatment cannot participate.
Patients who have not previously been treated with immune checkpoint inhibitors (a type of cancer treatment that helps the immune system fight cancer) cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

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IRCCS Humanitas Research Hospital
Verified
Rozzano, Italy

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Investigated drugs

Cabozantinib is a medication used in this clinical trial to treat patients with liver cancer, specifically hepatocellular carcinoma, who have not responded well to previous treatments with immune checkpoint inhibitors. It works by blocking certain proteins that promote cancer cell growth, helping to slow down or stop the progression of the cancer. This medication is being tested to see how effective it is as a second or third treatment option for these patients.

Cabozantinib

What is already known about the treatment

Cabozantinib – Cabozantinib is a medication administered orally in the form of a tablet. It is currently being studied for its effectiveness and safety in treating hepatocellular carcinoma, a type of liver cancer, especially in patients who have not responded well to or cannot tolerate previous treatments with immune checkpoint inhibitors. The drug works by blocking certain proteins that promote cancer cell growth and blood vessel formation, thereby slowing down the progression of the disease. Cabozantinib is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease typically progresses by forming a mass in the liver, which can grow and invade nearby structures or spread to other parts of the body. As the cancer advances, it may cause symptoms such as abdominal pain, weight loss, and jaundice. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly while others may spread rapidly. The disease is often detected at an advanced stage due to the lack of early symptoms.