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Study of durvalumab and tremelimumab with or without hepatic arterial infusion of gemcitabine and oxaliplatin in patients with high tumor burden hepatocellular carcinoma

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 study focuses on treating patients with hepatocellular carcinoma (a type of liver cancer) who have a high tumor burden. The treatment combines two medications: durvalumab and tremelimumab, which help the immune system fight cancer cells. Some patients will also receive chemotherapy drugs gemcitabine and oxaliplatin directly into the liver through a procedure called hepatic arterial infusion.

The main purpose is to determine if adding chemotherapy delivered directly to the liver improves treatment outcomes compared to using only the immune system medications. The study will measure how well tumors respond to treatment and how long patients survive with different treatment approaches.

During the study, participants will receive either the combination of immune system medications alone or together with the liver chemotherapy treatment. The medications will be given through intravenous infusion, while the chemotherapy drugs will be delivered directly into the liver through special tubes. Patients will have regular check-ups to monitor their health and assess how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment begins with a combination of three medications administered through intravenous infusion: IMJUDO (tremelimumab), IMFINZI (durvalumab), and directly into the liver (hepatic arterial infusion) - gemcitabine and oxaliplatin
This phase lasts for the first 12 weeks of the study
Step 2
Regular medical assessments
Your health status will be monitored through regular examinations and scans
Tumor measurements will be performed using CT scan or MRI to track any changes in tumor size
Blood tests will be conducted to monitor organ function and overall health status
Step 3
Quality of life evaluations
You will complete quality of life questionnaires every two months
These assessments will continue until either the disease progresses or the study ends
Step 4
Safety monitoring
Side effects will be monitored for 30 days after the end of any study treatment
Any health changes will be assessed according to standardized criteria
Step 5
Follow-up period
After completing treatment, you will continue to be monitored according to the study schedule
The total duration of follow-up will depend on your individual response to treatment

Who can join the trial?

22 criteria

Must be 18 years or older
Women who can become pregnant must:
- Use effective birth control during the study and for 90 days after treatment
- Have a negative pregnancy test within 7 days before starting treatment
- Men who are not sterile must use effective birth control during the study and for:
  - 90 days after durvalumab treatment
  - 12 months after oxaliplatin treatment
  - 3 months after gemcitabine treatment
  - Must not donate sperm or eggs during treatment and for 180 days after
  - Must sign an informed consent form before starting any study procedures
  - Must be able to attend all scheduled visits and follow study requirements
  - Must have health insurance or social security coverage
  - Must have advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed
  - Must have high tumor burden (extensive cancer spread in the liver)
  - Must have good liver function (Child-Pugh A)
  - Must be able to perform daily activities with minimal assistance (ECOG 0-1)
  - Must have a life expectancy of at least 12 weeks
  - Must weigh more than 30 kg
  - Must have at least one measurable tumor that can be monitored by CT or MRI scan
  - Must have adequate blood test results showing:
    
    Sufficient blood cell counts
    Acceptable kidney function
    Acceptable liver function tests
    Normal blood clotting
    Normal mineral levels

Who cannot join the trial?

15 criteria

Previous treatment with systemic therapy (medications that travel through the bloodstream) for liver cancer
Active or untreated brain tumors or brain metastases (cancer that has spread to the brain)
Severe liver disease (Child-Pugh C) or liver failure
History of organ transplant
Active or chronic hepatitis B infection that is not well controlled with medication
Major surgery within 4 weeks before starting the study treatment
Uncontrolled high blood pressure (hypertension)
Serious heart conditions, including:
- Heart attack within the last 6 months
- Unstable chest pain (angina)
- Severe heart rhythm problems
- Active bleeding problems or high risk of bleeding
- Pregnant or breastfeeding women
- Known allergies to the study medications
- Participation in another clinical trial within 4 weeks before this study
- Any other serious medical condition that could make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

Trial locations

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Investigated drugs

Durvalumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body's natural defenses to better recognize and attack the cancer. Tremelimumab is also an immunotherapy medication that works together with durvalumab. It helps activate your immune system's T-cells, which are important cells that can fight cancer. Together with durvalumab, it creates a stronger immune response against cancer cells. GEMOX is a combination chemotherapy treatment that includes two medications (gemcitabine and oxaliplatin). This is a more traditional type of cancer treatment that works by directly killing cancer cells or stopping them from growing. Hepatic Arterial Infusion Chemotherapy is a method of delivering chemotherapy directly to the liver through its main blood vessel. This targeted approach allows the medication to reach liver tumors more effectively while potentially reducing side effects in other parts of the body.

What is already known about the treatment

Durvalumab
A monoclonal antibody medication administered through intravenous infusion, which belongs to the class of immune checkpoint inhibitors used in cancer immunotherapy. It works by blocking the PD-L1 protein on cancer cells, allowing the immune system to better recognize and attack tumor cells, particularly in the treatment of hepatocellular carcinoma with high tumor burden. This medication is currently approved for various types of cancers and continues to be studied in clinical trials to expand its therapeutic applications.
Tremelimumab
An immunotherapy medication given via intravenous infusion that functions as a CTLA-4 inhibitor, belonging to the class of immune checkpoint inhibitors. It works by blocking the CTLA-4 protein, which helps activate T-cells in the immune system to fight cancer cells, specifically studied for treating hepatocellular carcinoma with high tumor burden. This medication is often used in combination with other immunotherapy drugs to enhance the body's immune response against cancer cells.
GEMOX
A combination chemotherapy regimen consisting of gemcitabine and oxaliplatin, administered through intravenous infusion. This treatment belongs to the class of cytotoxic chemotherapy drugs and works by interfering with cancer cell DNA replication and division, effectively killing rapidly dividing cells. It is commonly used in various cancer treatments, including hepatocellular carcinoma, and has shown effectiveness in patients with high tumor burden.

Investigated diseases

Hepatocellular carcinoma - A primary liver cancer that begins in the main type of liver cells (hepatocytes). It typically develops as a single tumor that grows larger over time or as multiple tumors throughout the liver. The disease usually progresses gradually, with tumors growing within the liver tissue and potentially spreading to nearby blood vessels. As the condition advances, it can affect normal liver function and may cause the liver to enlarge. The cancer can develop in people with chronic liver conditions, particularly those with cirrhosis. The tumor burden refers to the amount of cancer present in the body, with high tumor burden indicating significant presence of cancer tissue in the liver.