RecruitingNAINTERVENTIONAL

Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab

This study is focused on liver cancer (hepatocellular carcinoma) and aims to discover new biological markers, found in blood, that can predict how well patients will respond to a specific combination of immunotherapy drugs: tremelimumab and durvalumab. These drugs work by helping the body's own immune system fight cancer. While this combination has shown promise in improving survival for some patients, it doesn't work for everyone. Researchers want to identify specific signs in the blood that can tell us who is most likely to benefit, helping doctors make more informed treatment decisions in the future. The study involves collecting blood samples from patients already receiving this treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

120

Start

25 Jun 2025

Estimated completion

31 Jan 2030

Hepatocellular Carcinoma

What is this study about?

This study focuses on a type of liver cancer called hepatocellular carcinoma (HCC). Doctors are constantly looking for better ways to treat this cancer, and one promising approach is immunotherapy. Immunotherapy drugs work by 'waking up' your body's own immune system to recognise and fight cancer cells.

In this research, doctors are particularly interested in a combination of two immunotherapy drugs, tremelimumab and durvalumab. This combination has already shown good results in a large study called HIMALAYA, where it helped some patients with advanced liver cancer live longer. However, like many treatments, it doesn't work for everyone. The big question for researchers is: why do some patients respond really well to this treatment, while others don't?

To answer this, they are looking for something called 'biomarkers'. Think of biomarkers as clues found in your body, like in a blood sample, that can give doctors information about your health or how you might respond to a treatment. The goal of this study is to find new biomarkers that can predict which liver cancer patients are most likely to benefit from tremelimumab and durvalumab. This could eventually help doctors choose the best treatment for each patient.

Key takeaways

Aims to find blood clues (biomarkers) to predict treatment success.
Focuses on tremelimumab and durvalumab for liver cancer (HCC).
Requires only blood samples, no new treatments.
Participation helps future patients with liver cancer.
You must already be eligible for and receiving this specific treatment.
Your standard medical care will not be affected.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with hepatocellular carcinoma (liver cancer) that is considered locally advanced, has spread, or can't be removed by surgery. You must not have had any previous cancer treatments that affect your whole body, and your doctor must believe that the tremelimumab and durvalumab treatment is suitable for you.

There are also some other requirements, such as being at least 18 years old and being able to understand and agree to take part in the study. You also need to be part of the French social security system. The study requires that your cancer can be measured to see how treatment is affecting it.

However, you wouldn't be able to join if you've ever had certain types of previous immunotherapy treatments (like those that target PD-1, PD-L1, or CTLA4). Also, if you have any other serious medical or mental health conditions that would make it difficult or unsafe for you to participate, you would not be eligible. If you are under guardianship, you also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have locally advanced, metastatic, or unresectable liver cancer?
Have I had NO previous full-body cancer treatments?
Am I already considered suitable for tremelimumab and durvalumab by my doctor?
Am I at least 18 years old?
Do I currently have 'measurable disease' (can doctors track my cancer's size)?
Have I NOT had any previous immunotherapy drugs like anti-PD-1, anti-PD-L1, or anti-CTLA4?

Answer every question to see your result.

What does participation involve?

This study primarily involves providing blood samples. If you meet the eligibility criteria and decide to take part, you would provide blood samples at specific times during your ongoing treatment with tremelimumab and durvalumab. This is not a study where you receive new or experimental drugs; it's about collecting information from standard treatment. The exact number and timing of blood samples would be explained to you by the study team. You will continue to receive your prescribed treatment as decided by your doctor. The total duration of your participation would depend on your treatment plan and the study's collection schedule, but it does not change your treatment.

Potential risks and benefits

The main benefit of taking part in this study is that you would be contributing valuable information that could help future liver cancer patients. By discovering new biomarkers, doctors might be able to better predict who will respond best to certain treatments. As this study involves only blood samples from patients already receiving approved treatments, the risks beyond those of routine blood draws are minimal. There are no direct medical benefits to you personally from participating in this specific biomarker collection. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (10)

CHU de Besançon
Verified postcode
Besançon, France· Recruiting
CH de Chalon sur Saône
Verified postcode
Chalon-sur-Saône, France· Recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Recruiting
CH de Mulhouse
Verified postcode
Mulhouse, France· Recruiting
Hôpital Beaujon - APHP
Verified postcode
Paris, France· Recruiting
Hôpital Henri Mondor - APHP
Verified postcode
Paris, France· Not yet recruiting
Hôpital La Pitié Salpêtrière - APHP
Verified postcode
Paris, France· Recruiting
CHU Poitiers
Verified postcode
Poitiers, France· Not yet recruiting
CHU de Reims
Verified postcode
Reims, France· Not yet recruiting
ICANS
Verified postcode
Strasbourg, France· Not yet recruiting

Common questions

What is a 'biomarker'?

A biomarker is like a biological clue (often found in blood) that can help doctors understand your health or how your body might react to a treatment.

Will taking part in this study change my treatment?

No, this study does not involve new treatments. You will continue to receive your tremelimumab and durvalumab therapy as prescribed by your doctor.

What will I have to do if I join?

If you join, you will provide blood samples at various times while you are undergoing your standard treatment for liver cancer.

Are there any direct benefits for me?

There are no direct personal medical benefits. However, your contribution will help researchers learn more about liver cancer and how to treat it better in the future.

Is this a new drug trial?

No, this is not a trial of new drugs. It focuses on understanding how existing, approved drugs work in patients with liver cancer.

How to find out more

Angélique VIENOT, Dr

a3vienot@chu-besancon.fr +33 3 81 66 81 66 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.