RecruitingPHASE1, PHASE2INTERVENTIONAL

Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

This study is exploring a new way to treat advanced liver cancer, called hepatocellular carcinoma (HCC), especially when it has spread into blood vessels within the liver. Researchers are combining specific radiation therapies (Yttrium-90 or SBRT) with two powerful immunotherapy drugs, Atezolizumab and Bevacizumab. The main goal is to see if this combination helps more patients become eligible for a liver transplant, which can be a life-saving procedure. They also want to track how well patients live and whether their cancer returns over five years after the transplant. It's hoped this approach could offer a better chance for people with this type of advanced liver cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Dec 2024

Estimated completion

01 Jun 2034

Hepatocellular Carcinoma (HCC)Macrovascular Invasion Liver Transplant Surgery Downstaging

What is this study about?

This research study is looking into a new way to treat a type of advanced liver cancer called hepatocellular carcinoma (HCC). This is the most common kind of liver cancer. Sometimes, this cancer can grow into the blood vessels of the liver, which doctors call 'macrovascular invasion'. When this happens, it can make treatment more difficult, and often means a liver transplant isn't usually an option.

The study hopes to change that. Researchers are combining specific radiation treatments, like Yttrium-90 or Stereotactic Body Radiotherapy (SBRT), with two medicines called Atezolizumab and Bevacizumab. Atezolizumab is an immunotherapy drug that helps your body's immune system fight cancer, and Bevacizumab works by stopping the cancer from forming new blood vessels it needs to grow. The idea is that these treatments together might shrink the cancer enough to allow patients who previously couldn't have a liver transplant to become eligible for one.

The main aim is to find out how many patients with this advanced liver cancer can successfully receive a liver transplant and how well they live in the five years following the transplant. This is important because a transplant can offer a cure for liver cancer. By studying this new approach, doctors hope to give more people with advanced liver cancer a better chance at long-term health and a longer life.

Key takeaways

This study combines special radiation and immunotherapy drugs for advanced liver cancer.
The goal is to help patients become eligible for a life-saving liver transplant.
It's for people whose liver cancer has grown into blood vessels within the liver.
Participants will receive radiation, then specific medications for up to 9 months.
Follow-up will track survival and cancer return for five years after transplant.
You can withdraw from the study at any time if you change your mind.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 70 years old and weigh more than 30 kg (about 4 stone 10 pounds). Your liver health, measured by a score called Child Pugh Turcotte, should be A5 to B7, which means your liver is working reasonably well. The cancer must have grown into some of the larger blood vessels in your liver (macrovascular invasion, specifically Vp1-3), but the total size of your tumour shouldn't be too big (less than 350 cubic centimetres). Your Alpha Fetoprotein level, a marker for liver cancer, should also be below 5000 ng/mL.

It's also important that your cancer hasn't spread to other parts of your body, and you shouldn't have any other health conditions that would prevent you from having a liver transplant. Your general fitness level (ECOG score) should be good, meaning you can carry out most of your daily activities. You must also be able to understand and agree to take part in the study, and your liver cancer must be confirmed by scans and a tissue sample.

Things that would mean you can't join include if your cancer is a very aggressive type (poorly differentiated), if you've already had treatment for this liver cancer (except for surgery or ablation), or if the cancer has spread too far into the main portal vein. You also can't be severely overweight (obesity class III, BMI of 40 or more), or have any conditions that would stop you from receiving the planned radiation therapies or the Atezolizumab and Bevacizumab medications.

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.

Am I between 18 and 70 years old?
Does my liver cancer affect blood vessels within my liver?
Has my cancer NOT spread outside my liver?
Do I have a good general health and fitness level?
Have I NOT had previous liver cancer treatment (other than surgery/ablation)?
Am I able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey would typically involve several steps. First, you would have a small procedure to take a sample of your tumour (a biopsy). After this, you would receive the radiation treatment, either SBRT or Yttrium-90. Then, between 2 to 6 weeks later, you would start receiving the two medication treatments, Atezolizumab and Bevacizumab. You would continue these medications for up to 9 months.

Throughout this time, doctors will be carefully monitoring your progress. If the treatment is successful in shrinking your cancer and you meet all the necessary health requirements, you would then be put forward for a liver transplant. If a suitable liver is found and the transplant is considered safe, you would undergo the surgery. After the transplant, you would be followed up regularly for five years, with doctors collecting information about your health and whether the cancer returns. The total duration of active treatment with medication would be up to 9 months, followed by a long-term follow-up.

Potential risks and benefits

Participating in this study could potentially offer a benefit by making a liver transplant possible for you, which might not have been an option otherwise, potentially leading to a longer, healthier life. However, like all medical treatments, there are potential risks and side effects associated with the radiation therapies and the medications (Atezolizumab and Bevacizumab). These could range from mild to serious, and your medical team will discuss them in detail with you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

London Health Sciences Centre
Verified postcode
London, Canada· Not yet recruiting
Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'macrovascular invasion'?

This means your liver cancer has grown into one of the main blood vessels within your liver.

What are Atezolizumab and Bevacizumab?

These are medicines used together. Atezolizumab helps your immune system fight cancer, and Bevacizumab helps stop the cancer from growing new blood vessels.

What is a 'liver transplant'?

This is a major operation where a diseased liver is removed and replaced with a healthy liver from a donor.

Will I definitely get a liver transplant if I join?

No, the aim of the study is to see if this treatment can make a transplant possible for you, but it's not guaranteed. You still need to meet strict criteria and be deemed suitable.

What is 'locoregional therapy'?

This refers to the radiation treatments (Yttrium-90 or SBRT) that target the cancer specifically within the liver.

How to find out more

Clinical Research Manager

roxana.bucur@uhn.ca 437-772-4354 Official trial record

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