A trial looking at axitinib for advanced soft tissue sarcoma (Axi-STS)

Cancer type:

Soft tissue sarcoma




Phase 2

This trial looked at axitinib for several different types of soft tissue sarcoma that had spread. It was for people with a number of different types of soft tissue sarcoma including:

  • angiosarcoma
  • leiomyosarcoma
  • synovial sarcoma

The trial was supported by Cancer Research UK. It was open for people to join between 2010 and 2016. The research team published the results in 2023.

More about this trial

Doctors often treat soft tissue sarcoma with surgery, radiotherapy, chemotherapy, or targeted cancer treatments. Or a combination of these. But sometimes when soft tissue sarcoma has spread, it can be more difficult to treat. Researchers wanted to find out if axitinib is useful for people in this situation.

Axitinib is a type of targeted cancer treatment called a tyrosine kinase inhibitor (TKI). It stops the signals that tell cancer cells to form their own blood vessels. This can help slow the growth of the cancer, or even shrink it.

The main aims of this trial were to find out:

  • if axitinib can help stop soft tissue sarcoma growing
  • if axitinib can help people live longer
  • more about the side effects of axitinib

Summary of results

The results showed that axitinib could be a useful treatment for soft tissue sarcoma that has spread.

Trial design
This trial was for people with several different types of soft tissue sarcoma
They all had cancer that had spread to their lymph nodes or to another part of the body. 

They took axitinib tablets twice a day, for up to 2 years. 

A total of 145 people joined this trial. They had different types of sarcoma:

  • 39 people had angiosarcoma
  • 36 people had leiomyosarcoma
  • 36 people had synovial sarcoma
  • 34 people had other types of sarcoma

The trial team looked at how many people’s cancer had not got worse, 3 months after joining the trial. They were able to do this for 121 people. 

They found it was 54 people in total:

  • 13 out of 31 people (42%) with angiosarcoma
  • 15 out of 33 people (45%) with leiomyosarcoma
  • 17 out of 30 people (57%) with synovial sarcoma
  • 9 out of 27 people (33%) with other types of sarcoma

They also looked at how many people were living a year after joining the trial. They found it was:

  • 4 out of every 10 people (40%) with angiosarcoma
  • 4 out of every 10 people (40%) with leiomyosarcoma
  • nearly 5 out of every 10 people (47%) with synovial sarcoma
  • more than 3 out of every 10 people (34%) with other types of sarcoma

Side effects
Everyone taking part had at least one side effect. Many of these were mild or didn’t last long. But 56 people had at least one side effect that was more serious:

  • 17 people with angiosarcoma
  • 9 people with leiomyosarcoma
  • 20 people with synovial sarcoma
  • 10 people with other types of sarcoma

The most common side effects were:

  • extreme tiredness (fatigue)
  • raised blood pressure
  • sore mouth (mucositis)
  • feeling sick

The most common of the more serious side effects were fatigue and raised blood pressure.

Two people with leiomyosarcoma died because of side effects they were having. They both had bleeding problems, one in the lungs and the other in the bowel.

We have more information about the side effects of axitinib in our cancer drugs section.

The trial team concluded that axitinib could help stop advanced sarcoma growing in some people. And that it didn’t cause too many side effects. They suggest that other, larger trials are done to find out more.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Axitinib in patients with advanced/metastatic soft tissue sarcoma (Axi-STS): an open-label, multicentre, phase II trial in four histological strata
P Woll and others
British Journal of Cancer, 2023. Issue 129, pages 1490 - 1499.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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.

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

Chief Investigator

Professor Penella Woll

Supported by

Cancer Research UK
Cancer Research UK Clinical Trials Unit Birmingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield

Other information

This is Cancer Research UK trial number CRUK/09/009.

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3850

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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