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RecruitingPHASE2INTERVENTIONAL

Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

This study focuses on a type of liver cancer that doctors can remove with surgery. Even after surgery, this cancer can sometimes come back. We want to see if giving patients certain medications before and after their operation can reduce this risk. We're testing two drugs: pembrolizumab and lenvatinib. These drugs work in different ways to fight cancer, with pembrolizumab helping your own immune system. Some patients will get pembrolizumab, some will get lenvatinib, and some will receive both, for about six weeks before surgery. Everyone will then receive pembrolizumab for up to a year after surgery. The main goal is to see if these treatments can shrink the cancer more in the lab, which scientists hope means better long-term results for patients.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
University College, London
Enrolment target
60
Start
25 Aug 2022
Estimated completion
01 Jul 2030

What is this study about?

Liver cancer, also known as Hepatocellular Carcinoma (HCC), is a serious condition. While surgery is often the best way to treat it, unfortunately, the cancer can return in many patients within a few years. Doctors are always looking for better ways to prevent this from happening.

This study aims to investigate new treatment approaches for liver cancer that can be removed by surgery. We are particularly interested in two types of drugs: pembrolizumab and lenvatinib. Pembrolizumab is an 'immunotherapy' drug, which means it helps your body's own immune system find and fight cancer cells. Lenvatinib is another anti-cancer drug that targets specific pathways in cancer cells to stop them from growing and spreading. We want to see if using these drugs before surgery can make a difference, and if continuing pembrolizumab after surgery can help keep the cancer away.

The study will involve sixty patients who will be split into three groups at random. One group will get pembrolizumab before their surgery, another will get lenvatinib, and the third group will receive both drugs together. This pre-surgery treatment will last about six weeks. After surgery, all patients in the study will then receive pembrolizumab for up to a year. The main thing we'll be looking at is how much of the cancer is left in the removed tissue after the pre-surgery treatment, as this can tell us how well the treatment worked and potentially predict how you might do in the long run. We also want to see how safe these treatments are and how patients tolerate them.

Key takeaways

  • Tests new drugs (pembrolizumab and lenvatinib) for liver cancer that can be surgically removed.
  • Compares these drugs alone or combined, given before surgery.
  • All patients receive pembrolizumab after surgery for up to a year.
  • Aims to see if treatments shrink cancer more and prevent it from returning.
  • Involves regular clinic visits, blood tests, and scans.
  • Participation includes up to 18 months of treatment and up to 3 years of follow-up.

Who may be eligible?

This study is looking for adult patients (18 years or older) who have been diagnosed with a specific type of liver cancer called Hepatocellular Carcinoma (HCC). For you to be considered, your cancer must be suitable for surgical removal by doctors. Important points about your diagnosis include that it needs to be confirmed by scans, tissue samples, or cell tests, and it shouldn't be a rare subtype of liver cancer.

To ensure your safety and that the study results are clear, doctors will also check other aspects of your health. This includes making sure your liver is working well enough (a specific measure called Child-Pugh A), your blood tests are within certain ranges (like blood counts and kidney function), and you're generally fit enough for the treatment (doctors use a scale called ECOG Performance Status, looking for 0 or 1). If you've had hepatitis B or C, you might still be able to join, but specific conditions apply, such as the virus being well-controlled or undetectable.

The research team will carry out several tests to make sure you meet all the requirements for the study. If your liver cancer cannot be removed by surgery, or if you have other serious health conditions that could make the treatment unsafe for you, you would not be able to participate. They will explain all the criteria in detail and answer any questions you have.

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.

  1. Do I have Hepatocellular Carcinoma (HCC)?
  2. Can my liver cancer be removed by surgery?
  3. Is my liver generally healthy enough for surgery and treatment?
  4. Are my blood tests (like blood counts and kidney function) mostly normal?
  5. Am I generally well and able to manage new treatments?
  6. If I've had hepatitis B or C, is it well controlled or cured?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey will involve several stages. First, you'll undergo about six weeks of treatment before your surgery. During this time, you'll either receive pembrolizumab, lenvatinib, or both, depending on which group you are randomly assigned to. After your surgery, you will then continue with pembrolizumab treatment for up to a year.

Throughout these treatment periods, and for some time afterwards, you'll have regular visits to the clinic for assessments. These visits will involve blood tests, scans, and discussions with the study doctors and nurses to monitor your health, how you're responding to the treatment, and to check for any side effects. The total duration you'll be followed by the study team will be at least one year and could be up to three years after your post-surgery treatment ends. The researchers expect to take about two years to find all the patients for this study.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close monitoring of your health. It’s possible that these new approaches could improve the chances of your cancer not returning after surgery. However, like all medications, the drugs used in this study (pembrolizumab and lenvatinib) can have side effects, which can range from mild to serious. The research team will carefully explain all known side effects and monitor you very closely. It's important to remember that there's no guarantee the treatment will work for you, and there might be risks that are not yet fully understood. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Queen Elizabeth Hospital
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Western General Hospital
    Verified postcode
    Edinburgh, United Kingdom· Not yet recruiting
  • Beatson West of Scotland Cancer Centre
    Verified postcode
    Glasgow, United Kingdom· Not yet recruiting
  • St James's Hospital
    Verified postcode
    Leeds, United Kingdom· Not yet recruiting
  • Clatterbridge Cancer Centre
    Verified postcode
    Liverpool, United Kingdom· Not yet recruiting
  • Hammersmith Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • King's College Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Free Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie NHS Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Not yet recruiting
  • Freeman Hospital
    Verified postcode
    Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What kind of cancer is this study for?

This study is for a type of liver cancer called Hepatocellular Carcinoma (HCC) that doctors believe can be fully removed with surgery. It's not for all types of liver cancer.

What are pembrolizumab and lenvatinib?

Pembrolizumab is a drug that helps your immune system fight cancer. Lenvatinib is another anti-cancer drug that works by stopping cancer cells from growing and spreading.

How long will I be on the study treatment?

You'll have about six weeks of treatment before your surgery, and then up to 12 months of treatment with one of the drugs after surgery.

Will I know which treatment I'm getting?

This study randomly assigns patients to one of three groups. You will either receive pembrolizumab, lenvatinib, or both before surgery. Everyone then gets pembrolizumab after surgery. You or your doctor may not know which specific pre-surgery treatment you're getting until after you start.

What happens after the treatment ends?

After your treatment finishes, the study team will continue to follow your health for at least one year, and possibly up to three years, to see how you are doing long-term.

How to find out more

Michelle Hung

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

Interested in taking part?

Register your interest

Share your details and the research team for "Perioperative Pembrolizumab and Lenvatinib in Resectable Hep…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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