RecruitingOBSERVATIONAL

Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy

This research is investigating if a substance in the blood called Glypican-3 (GPC-3) can help predict how well immunotherapy treatment will work for people with a common type of liver cancer, hepatocellular carcinoma (HCC). HCC is often difficult to treat, but a new drug combination, Atezolizumab and Bevacizumab, has shown promising results. Doctors want to understand if measuring GPC-3, either by itself or with other blood markers, can identify which patients are most likely to benefit from this new treatment and possibly live longer. Ultimately, this could help tailor treatments more effectively for individual patients.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

240

Start

08 Sep 2023

Estimated completion

08 Sep 2029

Hepatocellular Carcinoma

What is this study about?

This study is focused on a type of liver cancer called hepatocellular carcinoma (HCC). For many years, treatment options for advanced HCC were quite limited. However, a recent major study showed that a combination of two drugs, Atezolizumab and Bevacizumab, can help people with advanced HCC live longer and keep their cancer from growing for a longer period compared to older treatments. This has changed how doctors approach the treatment of this cancer.

Now that this new treatment is available, doctors want to find ways to predict which patients will benefit the most from it. They are looking at a specific substance called Glypican-3 (GPC-3). GPC-3 is a protein that is often found in higher levels in people with HCC and has been linked to how the cancer behaves. The researchers believe that the amount of GPC-3 in a patient's blood might give clues about whether the Atezolizumab and Bevacizumab combination will be effective for them.

By measuring GPC-3 levels, perhaps alongside other existing blood tests, doctors hope to get a clearer picture of who will respond best to this immunotherapy. This information could make it easier to choose the right treatment for each patient, ensuring they get the most effective care possible for their liver cancer.

Key takeaways

The study aims to predict how well immunotherapy works for liver cancer.
It focuses on a substance called Glypican-3 (GPC-3) found in the blood.
Understanding GPC-3 levels could help doctors choose the best treatment.
This research looks at patients already receiving a new combination treatment (Atezolizumab + Bevacizumab).
It hopes to lead to more personalized cancer care in the future.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 90 years old with hepatocellular carcinoma (HCC), which is a common type of liver cancer. Your cancer should either have developed in a liver already affected by cirrhosis (scarring), or in a liver with another long-term condition but not yet scarred.

Crucially, your doctors must have decided that you are a suitable candidate for the Atezolizumab and Bevacizumab combination treatment, based on current medical guidelines. You also need to be able to understand French and agree to take part in the study after being fully informed about it.

However, there are also reasons why you might not be able to join. For example, if you have HIV, another immune system problem, are currently taking medications that suppress your immune system, or have autoimmune diseases, you would likely be excluded. Other reasons include having certain past liver procedures like a portosystemic shunt or a liver transplant, having a serious infection, or being pregnant or breastfeeding. People who are under legal guardianship or curatorship are also typically not included.

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.

Are you between 18 and 90 years old?
Do you have hepatocellular carcinoma (liver cancer)?
Have your doctors recommended you for treatment with Atezolizumab and Bevacizumab?
Do you not have HIV or other serious immune system problems?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study is focused on collecting and analyzing information, rather than being a treatment trial where you receive an experimental drug. If you already meet the criteria for treatment with Atezolizumab and Bevacizumab for your liver cancer, taking part in this study would involve providing additional blood samples. These samples would be used to measure the levels of Glypican-3 and other markers. You would also have your medical information, like treatment response and overall health, carefully monitored and recorded as you receive your standard care. The total duration of your participation would depend on your treatment journey but would involve ongoing collection of information and blood samples during your treatment. There are no specific additional visits to accommodate the study, as data would be collected during your routine medical appointments.

Potential risks and benefits

Participating in this study might help advance medical knowledge about who benefits most from current liver cancer treatments, potentially leading to better care for future patients. There are no direct medical benefits to you from having your blood analyzed for GPC-3 in this specific research. The main risk involves the minor discomfort and very small risk of bruising or infection from the additional blood draws. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Service hépato-gastroentérologie, Hôpital la Pitié-Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is Glypican-3 (GPC-3)?

GPC-3 is a substance found in the body, and levels can be higher in people with certain cancers, including liver cancer. This study is checking if it can help predict treatment success.

What is Hepatocellular Carcinoma (HCC)?

HCC is the most common type of liver cancer. This study focuses on people with advanced forms of this cancer.

What are Atezolizumab and Bevacizumab?

These are two drugs used together as a new treatment for advanced liver cancer, and they have shown better results than older treatments.

Will taking part in this study change my cancer treatment?

No, this study will not change your cancer treatment. It involves collecting extra information and blood samples while you receive your planned treatment.

Why is this study important?

It could help doctors understand who will benefit most from the Atezolizumab and Bevacizumab treatment, leading to more personalised and effective care for others with liver cancer in the future.

How to find out more

Manon ALLAIRE, Dr

manon.allaire@aphp.fr 0142161034 Official trial record

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