A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
This study, called LEAP-012, is looking for a new treatment for a type of liver cancer that hasn't spread to other parts of the body but can't be cured with surgery. Participants will be randomly given either a combination of two drugs, Lenvatinib and Pembrolizumab, along with a standard treatment called TACE, or just TACE on its own. We want to see if the new combination helps to stop the cancer from getting worse and if it improves how long people live. We'll also be checking for any side effects. This is a large study (Phase 3) that compares the new treatment to an existing one, to see if it's a better option for patients.
At a glance
What is this study about?
This clinical trial is investigating a new way to treat liver cancer, specifically a type called hepatocellular carcinoma. This is cancer that starts in the liver. The study is for people whose cancer hasn't spread to other parts of the body (we call this non-metastatic) but can't be completely removed by surgery.
The main idea behind this study is to see if combining two new medicines, Lenvatinib and Pembrolizumab, with a standard treatment called TACE (Transarterial Chemoembolization) works better than TACE alone. TACE is a procedure where doctors deliver cancer-fighting drugs directly to the tumour in the liver, then cut off its blood supply. Lenvatinib and Pembrolizumab are drugs that target cancer cells in different ways.
We want to find out if the new combination treatment can stop the cancer from growing for longer. We also want to see if it helps people live longer and if it shrinks the tumour more effectively. Of course, safety is very important, so we will also be carefully monitoring for any side effects that people experience during the study.
Key takeaways
- This study is for liver cancer that hasn't spread.
- It compares a new drug combination plus TACE with TACE alone.
- The aim is to see if the new combination stops cancer growth and helps people live longer.
- Participation involves regular hospital visits for treatment, tests, and monitoring.
- You won't know which treatment group you're in.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. You must have liver cancer (hepatocellular carcinoma) that has not spread to other parts of your body and cannot be completely removed by surgery or other local treatments.
The doctors running the study will carefully check your medical history, including any other health conditions you have and medicines you are taking, to make sure this study is safe and right for you. They will also do some tests to confirm your diagnosis and assess your general health.
There will be specific health requirements, for example, your liver and kidney function will need to be within a certain range. These checks are in place to protect your safety and ensure the study results are clear. Your doctor will be able to explain all the 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 liver cancer (hepatocellular carcinoma)?
- Has your liver cancer *not* spread to other parts of your body?
- Has your doctor told you that your liver cancer cannot be completely removed by surgery?
- Are you able to travel for regular hospital visits?
What does participation involve?
If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive the combination of Lenvatinib, Pembrolizumab, and TACE. The other group will receive TACE along with two placebo treatments (looks like the real drugs but contains no active medicine). This helps us fairly compare the effects. You will not know which group you are in, and your study doctor usually won't either.
Taking part will involve regular visits to the hospital for treatments, blood tests, scans (like CT or MRI), and check-ups to see how you are doing and to monitor for any side effects. These visits will vary in frequency. The study medication will be given as infusions (through a drip) and possibly pills, following a specific schedule. You'll have follow-up appointments even after treatment ends to track your long-term health. The total time you'd be involved in the study can vary, depending on how you respond to treatment and for long-term health checks.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedPortugal
- —UnverifiedItaly
- —UnverifiedIreland
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedNorway
Common questions
What is TACE?
TACE stands for Transarterial Chemoembolization. It's a procedure where doctors deliver cancer-fighting drugs directly to the liver cancer and then block the blood supply to the tumour.
What does 'non-metastatic' mean?
It means the cancer is still only in the liver and has not spread to other parts of your body.
Will I know which treatment I'm getting?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know which group you are in. This helps ensure fair and accurate results.
How long will I be in the study?
The time you spend in the study can vary. It will involve regular treatment and check-up visits, followed by long-term follow-up to monitor your health.
Can I leave the study at any time?
Yes, you can choose to leave the study at any point, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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