A study looking at targeting chemotherapy to the liver using focused ultrasound (TARDOX)

Cancer type:

Cancer spread to the liver
Liver cancer
Secondary cancers

Status:

Results

Phase:

Phase 1

This study was for people with liver cancer or with cancer that had spread to the liver from another part of the body (secondary liver cancer). 

More about this trial

Chemotherapy is a possible treatment for liver cancer or for cancer that has spread to the liver from another part of the body (secondary liver cancer). 

You usually have chemotherapy as tablets or as a drip into your vein. Both ways use the bloodstream to get the chemotherapy drug to the cancer. 

In this study, doctors looked at a new way to direct the chemotherapy specifically to the liver cancer. They did this by using a drug called lyso-thermosensitive liposomal doxorubicin (ThermoDox®). 

ThermoDox® is the chemotherapy drug doxorubicin wrapped in a fatty covering called liposome which melts a few degrees above body temperature. Doctors think that by gently heating a liver cancer whilst ThermoDox® is circulating in the bloodstream, more doxorubicin is released into the liver cancer, than if normal doxorubicin is given. Having more doxorubicin inside the liver cancer helps to kill more cancer cells. 

To warm up the ThermoDox® in the liver cancer, doctors used a special ultrasound scan called a focused ultrasound from outside of the body.

Summary of results

The study team concluded that it is possible to increase the amount of drug that goes inside cancers by targeting liver tumours with a focused ultrasound whilst ThermoDox® is in the bloodstream. But this was the first study of its kind and larger studies are needed to see how effective this treatment can be. 
 
This study started in 2014 and these results were published in 2018. 
 
Only 10 people took part in this phase 1 trial. They included:
  • 7 people with bowel cancer that had spread to the liver
  • 1 person with breast cancer that had spread to the liver
  • 1 person with lung cancer that had spread to the liver
  • 1 person with cancer that started in the liver (hepatocellular carcinoma)
Treatment
This was the first time people with liver cancer or cancer spread to the liver had this treatment. 
 
Everyone who took part had ThermoDox® as an injection into a vein shortly followed by focused ultrasound. 
 
First, doctors wanted to find out the focused ultrasound settings to achieve the temperature for the ThermoDox® to release the doxorubicin into the liver. They used a special thermometer to monitor the liver temperature during treatment. 
 
Once doctors found the best focused ultrasound settings, they stopped using the special thermometer so that treatment could be given using only a ThermoDox® drip and focused ultrasound from outside the body.
 
Results
Doctors looked at how well this treatment worked. To do this, they took tiny samples of tissue (biopsies Open a glossary item) from the target liver cancer after the ThermoDox® drip, and after using the focused ultrasound. 
 
They found that on average the amount of doxorubicin in the liver cancer was nearly 4 times higher after the ultrasound than after the drip. 
 
So doctors found that warming liver tumours using a focused ultrasound in the liver whilst ThermoDox® is in the bloodstream helps to release more doxorubicin compared to giving normal doxorubicin.
 
Side effects 
The study doctors looked at the most common side effects of treatment. The side effects were:
  • hair loss (alopecia)
  • tiredness (fatigue)
  • feeling or being sick
  • tummy (abdominal), muscle and bone pain
  • loss of appetite 
Doctors also looked at the moderate and severe side effects that people had:
Conclusion
The trial team concluded that it is possible to target chemotherapy to the liver by using ThermoDox® and a focused ultrasound. But this was a small study and the first time people with liver cancer or cancer spread in the liver had this type of treatment. 
 
Doctors want to continue to test this new way of giving chemotherapy to the liver. They want to learn more about how this treatment works and the side effects.  
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Mark Middleton

Supported by

Celsion Corporation
Oxford University Hospitals NHS Trust
University of Oxford 
NIHR Oxford Biomedical Research Centre
Oxford Biomedical Research Centre
Oxford Centre for Drug Delivery Devices
Engineering and Physical Sciences Research Council (EPSRC)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14064

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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