Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A phase I study evaluating safety and efficacy of Hepatic Intra- Arterial administration of ipilimumab in combination with Intra- venous nivolumab for advanced Hepatocellular carcinoma (HIPANIV)

This research is a study for people with advanced liver cancer that has spread or can't be treated with surgery. It's testing a new approach using two existing cancer drugs, ipilimumab and nivolumab. In this study, ipilimumab is given directly into the liver's artery, while nivolumab is given into a vein. The main goal is to check how safe this combination is, what side effects it might cause, and if it helps to control the cancer. This is an early phase study, meaning researchers are cautiously exploring new treatments to find out if they could become future options for patients. We're looking for adults aged 18 and over, both men and women, to take part.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Institut Gustave Roussy, Institut Gustave Roussy

Enrolment target

Start

08 Nov 2024

Advanced hepatocellular carcinoma

What is this study about?

This clinical trial is designed for individuals who have advanced hepatocellular carcinoma, which is a common type of liver cancer that has either spread or is difficult to treat with standard methods like surgery. The study is called HIPANIV, which is just a short way to refer to it. This research is combining two medicines that are already used to treat cancer, called ipilimumab and nivolumab. Both are types of immunotherapy, which means they work by helping your body's own immune system to fight the cancer cells.

What's special about this study is how one of the medicines, ipilimumab, is given. Instead of just going into a vein like typical intravenous treatments, it's given directly into the main artery of the liver. This is thought to help target the medicine more effectively to the cancer in the liver while nivolumab is given into a vein. By focusing the treatment this way, doctors hope to both improve how well the drugs work and possibly reduce side effects elsewhere in the body.

This study is in an early stage, called Phase I and Phase II. This means researchers are first checking to make sure the treatment is safe and to find the best dose. Once they've established the safety and a good dosage, they will then look closely to see how effective this combination treatment is at shrinking tumours or stopping the cancer from growing. This type of research is vital for finding new and better ways to treat serious illnesses like liver cancer, offering hope for future patients.

Key takeaways

This study is for advanced liver cancer.
It uses two existing immunotherapy drugs, ipilimumab and nivolumab.
Ipilimumab is given directly into the liver, nivolumab into a vein.
The main goals are to check safety and how well it works.
It's an early-stage trial (Phase I/II) to explore new treatment options.
Participants must be 18 or older.

Who may be eligible?

To be able to join this study, there are certain requirements you need to meet. The study is open to both men and women who are 18 years old or older. You will need to have a diagnosis of advanced hepatocellular carcinoma, which means liver cancer that has spread or cannot be removed by surgery.

There will be other specific health checks and tests that your study doctor will review. These checks are put in place to make sure that the treatment is as safe as possible for you and that you are suitable to receive the medicines being tested. For example, your overall health, other medical conditions you may have, and any other medications you are taking will all be carefully considered.

The research team will review your medical history and conduct several tests before you can participate. This careful screening process ensures that all participants are appropriate for the study and that any potential risks are minimised. It's important to understand that not everyone with advanced liver cancer will be able to join, as strict guidelines are necessary for patient safety and to get clear results from the research.

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 advanced hepatocellular carcinoma (liver cancer)?
Are you open to a treatment that involves medicine given directly into your liver artery?
Are you willing and able to attend regular hospital appointments and follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various assessments, including blood tests, physical examinations, and imaging scans (like CT or MRI scans) to monitor your health and how the treatment is working. You will receive the study medications, ipilimumab and nivolumab, on a set schedule. Ipilimumab will be given directly into an artery in your liver through a procedure, while nivolumab will be given into a vein. The frequency and duration of these treatments will be explained in detail by the study team.

You'll also have follow-up appointments after you finish receiving the medication to continue monitoring your health and any effects of the treatment. The total duration of your participation in the study will depend on how you respond to the treatment and the study's design, but it will involve a series of scheduled treatments and follow-up care over a period of time. All specific procedures and the overall timeline will be clearly outlined and discussed with you.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment approach for advanced liver cancer that isn't widely available yet. While this new combination aims to effectively target the cancer, there are also potential risks involved, including possible side effects from the medications and procedures, which will be carefully explained to you. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is hepatocellular carcinoma?

It's the most common type of liver cancer, often linked to long-term liver damage. 'Advanced' means it has spread or can't be treated with surgery.

What are ipilimumab and nivolumab?

These are cancer medicines called immunotherapies. They help your body's own immune system find and fight cancer cells.

What does 'hepatic intra-arterial' mean?

It means the medicine is delivered directly into the main artery that supplies blood to your liver. This aims to get the drug right to the cancer in your liver.

Why combine these two drugs?

Researchers want to see if using both drugs together, especially with one given directly to the liver, can be more effective at treating the cancer than using one alone or different methods.

Is this a new treatment?

Yes, this specific combination and delivery method is being tested in a clinical trial. While the drugs themselves exist, their use together in this way for liver cancer is experimental.