A Phase 2 Study of Tremelimumab (Day 1 only), Durvalumab (MEDI4736) and Trans-arterial catheter chemoembolization (TACE)in patients with advanced Hepatocellular Carcinoma (HCC)
This research study is for adults whose liver cancer has advanced. It is exploring whether a combination of two new cancer medicines, tremelimumab (IMJUDO) and durvalumab (IMFINZI), along with a standard treatment called Trans-arterial chemoembolization (TACE), can be effective. TACE involves delivering chemotherapy directly to the liver while blocking the blood supply to the tumour. The main goal is to see if this treatment can stop the cancer from growing for at least 6 months. Researchers will also be checking how safe the treatment is and if it helps people live longer or shrinks the cancer.
At a glance
What is this study about?
This study is looking into new ways to treat advanced hepatocellular carcinoma (HCC), which is a type of liver cancer that has spread or can't be removed by surgery. Doctors are trying out a new combination of treatments to see if it can help people with this condition.
The main idea is to combine two medicines, tremelimumab and durvalumab, with a treatment called Trans-arterial catheter chemoembolization (TACE). TACE is a special procedure where doctors put a tiny tube into an artery in your leg or groin and guide it to your liver. They then give chemotherapy medicine directly into the cancer and block its blood supply. The medicines tremelimumab and durvalumab work with your body's immune system to help fight the cancer.
The main goal of this study is to find out if this combination treatment can stop the cancer from growing for at least 6 months. Researchers will also be carefully watching to see if the treatment causes any side effects, if it helps people live longer, and if it makes the cancer shrink. The different medicines listed are simply the specific brand names and types of chemotherapy and imaging dyes used during the TACE procedure.
Key takeaways
- Tests a new combination of two medicines (tremelimumab and durvalumab) with TACE.
- Aims to see if this combination can stop advanced liver cancer from growing for at least 6 months.
- Will also check how safe the treatment is and its effect on tumour size and survival.
- Open to adults aged 18 and over with advanced liver cancer.
- Involves regular hospital visits for treatments, tests, and monitoring.
Who may be eligible?
This study is for adults aged 18 and over, of any gender, who have advanced liver cancer (hepatocellular carcinoma).
To join, you would need to meet certain health requirements. For example, your liver and kidney function would need to be at a certain level, and you shouldn't have other serious medical conditions that might make the treatment unsafe for you. You would also need to have not received certain types of cancer treatments recently.
The doctors running the study will check your medical history and do some tests to make sure that the study is a suitable and safe option for you.
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 of age or older?
- Do you have a diagnosis of advanced liver cancer (hepatocellular carcinoma)?
- Are you generally well enough to undergo cancer treatment?
- Are you willing and able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive the new combination treatment, which includes specific medicines given by infusion (into a vein) and the TACE procedure. The exact schedule of treatments would be carefully explained by the study team.
Throughout the study, you would have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment and to monitor for any side effects. You might also have additional tests to look at your immune system.
The study would involve regular follow-up for a period after your main treatment has finished to continue monitoring your health and the cancer. The total duration of your participation, including treatment and follow-up, would be determined by your response to the treatment and the study plan, which would be explained in detail.
Potential risks and benefits
Locations (1)
- —UnverifiedIreland
Common questions
What is advanced hepatocellular carcinoma?
It's a type of liver cancer that has grown or spread beyond the liver, or can't be treated with surgery.
What is TACE?
TACE stands for Trans-arterial chemoembolization. It's a procedure where chemotherapy medicine is delivered directly to the liver tumour, and its blood supply is partially blocked.
What do tremelimumab and durvalumab do?
These are medicines that help your body's own immune system find and fight cancer cells.
What does 'Progression-free survival' mean?
It's how long a person lives with cancer without the cancer getting worse (progressing) or growing.
Will I have to pay to be in the study?
No, you will not have to pay for the study treatments or assessments. These costs are covered by the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.