RecruitingPHASE3INTERVENTIONAL

Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma

This study is looking at the best way to treat a type of liver cancer called hepatocellular carcinoma. One existing treatment, called TACE, involves injecting chemotherapy directly into the liver cancer. However, the cancer often grows back after TACE alone. Researchers want to see if adding a newer, very precise radiation treatment called Stereotactic Body Radiation Therapy (SBRT) can make TACE more effective. SBRT uses highly focused radiation beams to target the tumour more accurately. This study, for adults aged 18 and over, will compare patients receiving TACE on its own with those receiving TACE plus SBRT, to find out which approach offers better control over the liver cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

128

Start

27 May 2019

Estimated completion

01 Jun 2027

Hepatocellular Carcinoma

What is this study about?

This clinical trial is designed to investigate different ways of treating liver cancer, specifically a type called hepatocellular carcinoma. For many people, the cancer stays within the liver, which means there's a good chance of treating it successfully. While surgery or a liver transplant can be very effective, not everyone is suitable for these options.

A common treatment for liver cancer that cannot be removed by surgery is called Transarterial Chemoembolization (TACE). With TACE, doctors inject chemotherapy directly into the blood vessels that feed the liver tumour. This helps deliver the medication right where it's needed, usually with fewer side effects than traditional chemotherapy. Although TACE can work well for some, especially for smaller tumours, the cancer can often return or continue to grow, particularly with larger tumours.

Researchers are now exploring if a more advanced radiation treatment, called Stereotactic Body Radiation Therapy (SBRT), can improve upon TACE. SBRT uses highly focused, powerful beams of radiation that can precisely target the liver tumour, being more accurate and potentially more effective than older radiation methods. The main goal of this study is to compare TACE alone with a combination of TACE plus SBRT to see if adding SBRT leads to better control of the liver cancer and improved long-term results for patients.

Key takeaways

Compares TACE alone vs. TACE plus SBRT for liver cancer.
Aims to improve cancer control with focused radiation (SBRT).
For adults with hepatocellular carcinoma or liver metastases.
Participation involves monitoring and follow-up.
Potential for better outcomes, discusses risks and benefits.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) with certain types of liver cancer or cancer that has spread to the liver (but not lymphoma). Your doctors must have decided that surgery is not the best option for your cancer.

You should have no more than five liver lesions (cancerous spots), and the largest of these shouldn't be bigger than 25 centimetres. If you have other cancer elsewhere in your body, it must be decided that the liver involvement is the main concern impacting your life. All your liver cancer must be suitable for the TACE treatment.

Your general health needs to be good enough to participate, and certain blood test results must fall within healthy ranges. If you've had chemotherapy recently, there are specific timeframes you need to wait before joining. Women who could become pregnant and men who could father a child must agree to use effective contraception during 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 years or older?
Do you have liver cancer (hepatocellular carcinoma) or cancer that has spread to your liver (not lymphoma)?
Have doctors said that surgery is not the right treatment for your liver cancer?
Do you have 5 or fewer cancerous spots in your liver, with none larger than 25cm?
Are your recent blood tests generally within healthy ranges?
Are you able to use reliable contraception if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups: either receiving TACE alone or TACE combined with SBRT. You will have regular appointments for check-ups, blood tests, and scans (like CT or MRI) to monitor your cancer and overall health. The specific number of visits and tests will vary depending on your treatment plan and how you are responding, but you can expect at least one pre-treatment assessment outlining your health and cancer status. The total duration of your participation will involve the treatment periods and follow-up appointments to track your progress over time.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving an enhanced treatment that could lead to better control of your liver cancer. However, as with any medical treatment, there are potential risks, including side effects from chemotherapy or radiation, which your doctor will discuss in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

London Health Sciences Centre, London Regional Cancer Program
Verified postcode
London, Canada· Recruiting

Common questions

What is Transarterial Chemoembolization (TACE)?

TACE is a treatment where chemotherapy drugs are injected directly into the blood vessels that supply the liver cancer to block the blood flow to the tumour.

What is Stereotactic Body Radiation Therapy (SBRT)?

SBRT is a very precise type of radiation treatment that delivers high doses of radiation to a tumour in the body, targeting it very accurately while trying to spare surrounding healthy tissue.

Why is this study being done?

This study is trying to find out if combining TACE with SBRT works better at controlling liver cancer than TACE alone, especially since cancer can often grow back after TACE.

Is this a new treatment?

TACE is an established treatment. SBRT is a newer, very accurate form of radiation, and this study is investigating if adding it to TACE is a more effective overall approach for liver cancer.

What kind of liver cancer is this study for?

This study is primarily for hepatocellular carcinoma, which is the most common type of primary liver cancer, or cancer that has spread to the liver from elsewhere in the body (but not a type called lymphoma).

How to find out more

Michael Lock, M.D.

michael.lock@lhsc.on.ca 519-685-8650 Official trial record

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