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Study of cabozantinib with atezolizumab compared to sorafenib in untreated patients with advanced liver cancer (hepatocellular carcinoma)

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What is this study about?

This study focuses on treating patients with advanced Hepatocellular Carcinoma (a type of liver cancer) who have not received previous cancer treatment. The study compares two different treatment approaches: a combination of two medications (cabozantinib and atezolizumab) versus a single medication (sorafenib).

The medications used in this study work in different ways to fight cancer. Cabozantinib and sorafenib are taken as tablets by mouth, while atezolizumab is given through an intravenous infusion (through a vein). Cabozantinib is also known by its code name XL184. The purpose of this study is to determine if the combination of cabozantinib and atezolizumab works better than sorafenib alone in treating liver cancer.

During the study, patients will receive either the combination treatment of cabozantinib and atezolizumab, or sorafenib alone. The study will monitor how the cancer responds to these treatments over time. The medications will be given according to a specific schedule, with regular check-ups to monitor the patient’s health and the effectiveness of the treatment.

1 Initial assessment

Your eligibility for the study will be confirmed based on liver cancer diagnosis through imaging or tissue examination

Your liver function will be evaluated to confirm Child-Pugh Score A

Your overall physical condition will be assessed using the ECOG performance scale (must be 0 or 1, indicating good physical condition)

2 Treatment assignment

You will be randomly assigned to one of the treatment groups:

Group 1: Cabozantinib tablets (20mg or 60mg) taken by mouth plus Atezolizumab given through intravenous infusion

Group 2: Sorafenib tablets (200mg) taken by mouth

3 Treatment period

The treatment will continue until your disease progresses or other stopping criteria are met

Regular imaging scans will monitor your cancer’s response to treatment

Your overall health status and any side effects will be monitored throughout the study

4 Follow-up period

After treatment completion, your health status will continue to be monitored

Regular check-ups will assess your cancer status and overall survival

The study is expected to continue until December 31, 2025

Who Can Join the Study?

  • Age requirement: Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of liver cancer (hepatocellular carcinoma) through either:
    • Tissue sample examination, or
    • Special imaging tests (CT or MRI scans) if you have liver cirrhosis
  • Your cancer must not be suitable for treatments that could potentially cure it, such as:
    • Liver transplant
    • Surgery
    • Tumor destruction procedures
    • Local treatments directly to the liver
  • Must have cancer that can be measured on imaging scans
  • Must have intermediate or advanced stage liver cancer (Barcelona Clinic Liver Cancer stage B or C)
  • Must have good liver function (Child-Pugh Score A)
  • Must be able to perform daily activities with minimal assistance (ECOG performance status of 0 or 1, meaning you can do light work and most daily activities)
  • Both men and women may participate

Who Cannot Join the Study?

  • Prior treatment with any systemic anti-cancer therapy for hepatocellular carcinoma (liver cancer)
  • Known presence of brain metastases (cancer that has spread to the brain) or spinal cord compression
  • History of organ transplant
  • Active or recent significant bleeding episodes within the last 3 months
  • Uncontrolled high blood pressure
  • Major surgery within 8 weeks before starting the study
  • Severe heart conditions, including heart attack within the last 6 months
  • Active autoimmune disease (when body’s immune system attacks its own cells)
  • Current or recent use of immunosuppressive medications (drugs that lower immune system activity)
  • Active hepatitis B or C infection
  • HIV infection or AIDS
  • Pregnancy or breastfeeding
  • Known allergic reactions to the study medications
  • Participation in another clinical trial within 28 days before starting this study
  • Inability to swallow oral medications
  • Any condition that would make participation unsafe or compromise study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
University Of Debrecen Debrecen Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Iyrygrfu Cjxfmo Duytvishcelcotznk L'hospitalet De Llobregat Spain
Cgyv Dt Ncqze Vandoeuvre Les Nancy France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.04.2019
France France
Not recruiting
30.04.2019
Hungary Hungary
Not recruiting
30.04.2019
Romania Romania
Not recruiting
30.04.2019
Spain Spain
Not recruiting
30.04.2019

Trial locations

Investigated drugs:

Cabozantinib is a medication that targets specific proteins in cancer cells, helping to stop their growth and spread. It works by blocking signals that cancer cells use to grow and create new blood vessels. It is used to treat liver cancer (hepatocellular carcinoma).

Atezolizumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body’s natural defenses to better fight the cancer.

Sorafenib is a targeted therapy medication used to treat liver cancer. It works by blocking several proteins that help cancer cells grow and form new blood vessels. This medication has been a standard treatment option for advanced liver cancer.

Hepatocellular carcinoma – A primary type of liver cancer that begins in the main liver cells called hepatocytes. The disease typically develops in people who have chronic liver conditions, such as cirrhosis. It starts as small changes in liver cells that gradually develop into cancerous growths. As the condition progresses, tumors can form within the liver tissue and may spread to other parts of the organ. The cancer can cause the liver to enlarge and may affect its normal functions. This condition is more common in men than in women and typically occurs in older adults.

Trial ID:
2024-516479-34-00
Protocol code:
XL184-312
Trial Phase:
Therapeutic confirmatory (Phase III)

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