Active not recruitingPHASE2INTERVENTIONAL

Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation Procedure

This clinical trial is looking at a new treatment approach for a type of liver cancer called Hepatocellular Carcinoma (HCC). We are studying two medicines, Durvalumab and Tremelimumab, given before a procedure to remove the cancer, and then Durvalumab alone given afterwards. The procedure involves using a special technique to destroy the cancer cells without surgery. The main goal is to find out if this combination of medicines and the procedure is safe and works well for people with early-stage HCC. This is a Phase 2 trial, meaning we are still gathering more information on its effectiveness and safety. Participants will receive one dose of both medicines, then the cancer removal procedure, followed by monthly doses of Durvalumab for nearly a year.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

28 Mar 2024

Estimated completion

27 Sep 2028

HCC - Hepatocellular Carcinoma

What is this study about?

This study is about finding better ways to treat a type of liver cancer known as Hepatocellular Carcinoma (HCC). Doctors often treat HCC with procedures that remove or destroy the cancer without major surgery, like 'percutaneous ablation'. This trial explores whether adding special medicines, Durvalumab and Tremelimumab, can make these existing treatments even more effective.

These medicines are a type of treatment called immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells. The idea is that giving these medicines before the ablation procedure might 'wake up' the immune system to tackle the cancer, and then continuing Durvalumab afterwards could help prevent the cancer from coming back. Earlier research suggests that combining these immune-boosting medicines with procedures like ablation could be a promising step forward.

We are looking into this because current treatments for advanced HCC often include similar immunotherapies, and early results for using them with procedures to remove early-stage HCC have been encouraging. By participating in this study, you would be helping us learn if this new approach can lower the chances of HCC returning and improve long-term outcomes for patients.

Key takeaways

This study combines immunotherapy medicines with a non-surgical procedure for liver cancer.
It's for people with early-stage liver cancer (HCC).
The goal is to see if this combination is safe and helps prevent cancer from returning.
You'll receive infusions before and after a procedure to remove the cancer.
The study lasts about two years, including treatment and follow-up.

Who may be eligible?

This study is looking for adults aged 18 to 85 who have been diagnosed with a specific type of liver cancer called HCC. Your cancer can be newly diagnosed or have returned after a previous treatment, as long as it's been at least six months since your last treatment. We are specifically looking for people whose cancer is in an early stage (BCLC A) and can be treated with a procedure called percutaneous ablation, which means destroying the cancer without an operation.

To join, your liver and kidney health need to be good, and your general fitness level should allow you to participate in the study. We'll check your blood tests to make sure your body is ready for the treatment. Your doctors will review all your health information to confirm if this study is a good fit for you.

There are also a few practical requirements, like being part of a social security system and being able to provide your written consent to join the study. If you are a woman who can become pregnant or a man or woman who can father a child, you would need to use effective birth control during and for several months after the study.

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 to 85 years old?
Have you been diagnosed with early-stage liver cancer (HCC)?
Is your liver cancer suitable for a procedure called percutaneous ablation?
Is your general health, including your liver and kidneys, in good condition?
Are you able to use effective birth control if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect. First, you'll receive a single dose of two medications, Durvalumab and Tremelimumab, through a drip (infusion) into your vein. About a month later, you will have the percutaneous ablation procedure to destroy the cancer, usually performed at a hospital.

After the procedure, you will receive more doses of just Durvalumab once a month for 11 months, also given by infusion. Throughout this period, you will have regular visits for blood tests and check-ups to see how you are responding and to monitor any side effects. Following the 11 months of Durvalumab, you'll have follow-up appointments every three months for an additional year to monitor your health and ensure the cancer hasn't returned. The total duration of active treatment and follow-up in the study will be about two years.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new treatments that aren't yet widely available, and you'll receive close medical attention. While these medications and procedures are designed to help, there's no guarantee that the treatment will be effective for everyone, or that it will prevent the cancer from returning. Like all medicines and medical procedures, there is a possibility of side effects, which the study team will discuss in detail with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hospitl Avicenne
Verified postcode
Bobigny, France

Common questions

What is liver cancer (HCC)?

Hepatocellular Carcinoma (HCC) is the most common type of liver cancer. This study is for people with early-stage HCC.

What are Durvalumab and Tremelimumab?

These are special medicines called immunotherapies that help your body's immune system fight cancer cells. They are given through a drip.

What is percutaneous ablation?

It's a procedure where a doctor uses a needle or probe to destroy cancer cells in the liver without needing to cut open your body.

How long will I be in this study?

The active treatment involves infusions for about a year, followed by an additional year of regular check-ups. So, roughly two years in total.

Will I still receive standard care if I join?

Yes, you will receive the study treatment, and your overall medical care will continue as normal. You will be closely monitored by the study team.