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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Sainte Catherine	Avignon	France
CHU de Toulouse – Hôpital Pierre-Paul Riquet	Toulouse	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Hasapolo Uddnvufhnaxmjs Scnglnkvid &grnxkx Hnxbuhz dn Hsmqfyblyyb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Hepatocellular carcinoma

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.

Trial ID:

2024-514912-28-00

Protocol code:

UC-GIG-2406

NCT ID:

NCT06904170

Trial Phase:

Therapeutic use (Phase IV)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?