A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients with Melanoma and Liver Metastases
This is an early research study, often called a Phase I trial. It's for adults who have melanoma, a type of skin cancer, that has spread to their liver. This includes melanoma that started in the skin or the eye. The study is looking at a new way to treat the cancer using a patient's own immune system. Doctors will take immune cells from the patient's body, train them to fight the cancer, and then put them back directly into the liver. The main goal is to find out if this treatment is safe and how the body reacts to it, rather than focusing on how well it works at this stage. It's a small study to gather initial information about this new approach.
At a glance
What is this study about?
This study is a type of early research called a Phase I trial. This means it's one of the first times this specific treatment is being tested in people. The main purpose of these early studies is to check for safety and to see what dose of the treatment might be best. It's not usually about seeing if the treatment can cure the cancer at this stage, but more about understanding how it works and if it's safe enough to study further.
The trial is for adults who have melanoma, which is a serious type of skin cancer that has spread to their liver. This includes melanoma that started on the skin as well as melanoma that began in the eye (called uveal or ocular melanoma) and has also spread to the liver. The treatment being tested uses your body’s own natural defence system, called the immune system.
Here’s how it generally works: the researchers will collect special immune cells from your body that naturally fight cancer, called 'tumour infiltrating lymphocytes' or TILs. They will then grow many more of these cells in a laboratory and train them to become even better at finding and destroying cancer. Once ready, these specially prepared cells will be put directly into the liver through a small tube. The idea is that these boosted immune cells will then target and attack the cancer cells in your liver.
Key takeaways
- This is an early-stage (Phase I) study for melanoma that has spread to the liver.
- It uses a new treatment approach involving the patient's own immune cells.
- The main goal is to check how safe the treatment is.
- Participation involves special procedures and close monitoring.
- Your involvement could help advance future cancer treatments.
Who may be eligible?
This study is looking for adults who have melanoma that has spread to their liver. This includes skin melanoma or melanoma that started in the eye. You must be at least 18 years old to take part, and there's no upper age limit.
To be considered for this study, you would need to have certain health checks to make sure your body can handle the treatment. This includes normal organ function and other specific health requirements as determined by the study doctors.
It’s important to remember that not everyone with these conditions will be able to join. The study doctors will carefully review your medical history and test results to decide if this study is suitable and safe for you. They will explain all the specific requirements in detail.
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?
- Do you have melanoma that has spread to your liver?
- Are you able to travel to the study clinic for appointments?
- Are you willing to undergo special procedures to receive the treatment?
- Are you comfortable with being closely monitored by doctors during the study?
What does participation involve?
If you decide to take part, you would first have a number of tests and scans to check your overall health and the extent of your cancer. This might include blood tests, imaging scans (like MRI or CT), and possibly a biopsy to collect the immune cells needed for the treatment.
The main treatment involves a hospital stay to receive the immune cells. These cells will be given directly into your liver through a special procedure. You would be closely monitored by the medical team during and after this treatment. There will also be follow-up visits, which could involve more blood tests, scans, and check-ups to see how you are doing and how your body is responding to the treatment. The total duration of participation, including follow-up, would be fully explained by the study team.
Potential risks and benefits
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Common questions
What is melanoma?
Melanoma is a serious type of skin cancer that can sometimes spread to other parts of the body, like the liver. It can also start in the eye (uveal or ocular melanoma).
What does 'Phase I study' mean?
A Phase I study is the first step in testing a new treatment in people. Its main goal is to check for safety and to find the right dose, rather than seeing if the treatment cures the disease.
What are 'immune cells'?
Immune cells are part of your body's natural defence system. They help fight off infections and diseases, including cancer. In this study, special immune cells are used.
Will I get better if I join this study?
Because this is an early-stage study, we cannot promise that you will get better. The main aim is to learn if the treatment is safe for people. Any potential benefits are still being investigated.
Do I have to pay to join the study?
No, you do not have to pay to participate in the study. All study-related treatments and tests are provided as part of the research.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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