CHRU De Nancy
Vandoeuvre Les Nancy, France
Not recruitingRare disease
Study of cabozantinib with atezolizumab compared to sorafenib in untreated patients with advanced liver cancer (hepatocellular carcinoma)
Fast replyRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- 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 trial?
16 criteria
- 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
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Responsive Verified Centre hospitalier universitaire de Liege
Liege, BelgiumVerified Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Spain
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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.
What is already known about the treatment
Cabozantinib
An oral tyrosine kinase inhibitor administered in tablet form that works by blocking specific proteins responsible for cancer cell growth and spread. It is currently approved for treating various types of cancer, including advanced hepatocellular carcinoma, and works by inhibiting multiple receptor pathways involved in tumor growth, angiogenesis, and metastasis. This targeted therapy belongs to the class of protein kinase inhibitors and helps reduce tumor size and slow cancer progression.
Atezolizumab
An immunotherapy medication administered through intravenous infusion that helps the immune system fight cancer cells. It belongs to the class of PD-L1 inhibitors and works by blocking a protein that prevents T-cells from attacking cancer cells, thereby enabling the immune system to better recognize and destroy cancer cells. This monoclonal antibody is currently used in treating various types of cancer and has shown promising results in clinical trials.
Sorafenib
An oral multikinase inhibitor taken in tablet form that targets multiple protein kinases involved in cancer cell growth and blood vessel development. It is a standard treatment option for advanced hepatocellular carcinoma and works by blocking specific proteins that promote cancer cell survival and tumor blood vessel formation. This medication belongs to the class of targeted therapies and has been proven effective in extending survival in patients with advanced liver cancer.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516479-34-00Protocol codeXL184-312Estimated enrolment582 patientsSponsorExelixis Inc.
sourced from the EU Clinical Trials Register and site verification
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