RecruitingPHASE1INTERVENTIONAL

Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma

This study is investigating a new treatment approach for advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed or treated with a liver transplant. It combines two medicines, ipilimumab and nivolumab, which are already used to treat some cancers. In this study, ipilimumab will be delivered directly into the main artery of the liver, while nivolumab will be given into a vein. The main goal is to find the highest dose of ipilimumab that can be given safely when combined with nivolumab. Researchers will carefully watch for any serious side effects during the first month of treatment to determine the best dose for future studies. This research aims to offer new options for patients who haven't responded to standard treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

Start

13 Nov 2020

Estimated completion

01 Nov 2024

Hepatocellular Carcinoma

What is this study about?

This research study is focused on people who have advanced liver cancer, specifically a type called hepatocellular carcinoma. This is when the cancer has grown to a stage where it can't be completely removed by surgery, and a liver transplant isn't an option. For many patients in this situation, unfortunately, standard treatments might not be working well, or they might not be suitable for them. That's why doctors are always looking for new and better ways to fight this disease.

The study uses two existing cancer drugs: ipilimumab and nivolumab. These drugs work by helping your body's own immune system to recognise and attack cancer cells. This is often called immunotherapy. What's different in this study is how one of the drugs, ipilimumab, is given. Instead of going into the bloodstream like nivolumab, it will be delivered directly into the main artery that supplies blood to the liver. The idea behind this is that by putting the drug right where the cancer is, it might be more effective and have fewer side effects elsewhere in the body.

The first main goal of this particular study (which is a 'Phase 1' study) is to find the safest and best dose of ipilimumab to give directly into the liver when it's used alongside nivolumab given into a vein. Researchers will start with a lower dose and slowly increase it, while carefully monitoring patients for any serious side effects. Once they find the dose that is tolerated best by most patients, this will be the recommended dose for further studies that will look at how well the treatment works.

Key takeaways

Tests a new combination treatment for advanced liver cancer.
Ipilimumab delivered directly to the liver, Nivolumab into a vein.
Primary goal is to find the safest and best dose.
Suitable for patients who haven't responded to standard treatments.
Requires regular hospital visits and medical checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have liver cancer (hepatocellular carcinoma) that has been confirmed by a doctor and is considered too advanced for surgery or a liver transplant. You also need to have tried standard first-line treatments for your cancer and either found they didn't work, couldn't tolerate them, or chose not to have them.

It's important that you have active liver cancer that has not been fully treated by other local procedures like chemoembolization. We need to be able to measure your cancer to see if the treatment is working. You can have a viral infection like Hepatitis B or C, as long as it's being properly managed.

Your general health needs to be good enough to take part. This includes having good organ function, like your kidneys and blood counts. We'll check these with blood tests. You should also be able to move around and do daily activities fairly easily (doctors call this an ECOG status of 0 or 1), and expect to live for at least 12 more weeks. Your liver function also needs to be reasonably healthy, without a history of serious liver problems or fluid build-up.

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 18 years old or older?
Have you been diagnosed with liver cancer (hepatocellular carcinoma)?
Has your doctor said your liver cancer cannot be removed by surgery or receive a liver transplant?
Have you tried standard treatments for your cancer that didn't work or weren't suitable?
Do you have generally good health, good organ function, and are still active?
Are you able to attend regular hospital visits and undergo medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have several tests to make sure the study is right for you. If you qualify, you will receive treatment. This involves two different medications: Ipilimumab will be given directly into the artery that goes to your liver, and Nivolumab will be given into a vein in your arm. You will have regular appointments and tests, including blood tests and scans, to check how you're responding to the treatment and to look for any side effects.

Researchers will also collect special samples (like blood samples) to understand how the medicines work in your body. Throughout the study, you'll be closely monitored, especially during the first month after receiving ipilimumab, to see how you tolerate the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but close follow-up will continue for some time after treatment ends.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially benefit your health if the treatment works for you. However, there are also risks. The medicines used can cause side effects, some of which could be serious or unexpected. Because this is a dose-finding study, researchers will be carefully watching for side effects to determine the safest dose. You might also have to attend many appointments and undergo various tests, which can be time-consuming. It's important to remember that the new treatment might not work for everyone, and it might not be better than existing treatments. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is hepatocellular carcinoma?

It's the most common type of primary liver cancer that starts in the main cells of the liver.

Are these new drugs?

Ipilimumab and nivolumab are existing cancer drugs, but this study is looking at a new way to combine them and deliver one directly to the liver.

What does 'Phase 1' mean?

Phase 1 means this is an early study primarily focused on finding a safe dose and understanding potential side effects, rather than how effective it is.

Will I get better quickly?

This study is about finding the best dose. While there's a chance of benefit, it's not guaranteed, and the main goal is to learn more for future patient care.

Can I still join if I have Hepatitis B or C?

Yes, you might be able to, as long as your Hepatitis is being properly treated and controlled by your doctors.

How to find out more

Lambros Tselikas, MD

lambros.tselikas@gustaveroussy.fr +33 (0)1 42 11 42 11 Official trial record

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