CompletedPhase IIInterventional

A study to see how effective the drug Axitinib is at preventing cancer cells from growing and to see if this means that patients with kidney cancer require less extensive surgery

This phase 2 clinical trial is studying a targeted cancer drug called axitinib for people with a common type of kidney cancer called clear cell renal cell cancer. In some patients, the cancer spreads as a plug into the large veins that carry blood away from the kidney and back towards the heart. When this happens, surgery to remove the tumour can be very major and challenging. In this study, patients take axitinib tablets for a short period before having their planned operation. Axitinib works by blocking signals that cancer cells need to grow and build new blood supplies. Doctors want to find out whether this treatment can shrink the tumour inside the veins before surgery takes place. If it works, it could reduce the size of the operation, lower surgical risks, and improve recovery for patients.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Common Services Agency

Enrolment target

Start

01 Dec 2017

Estimated completion

06 Jan 2020

Clear cell renal cell cancer with venous thrombus invasion

What is this study about?

The kidneys filter your blood and remove waste, sending cleaned blood back to your heart through large blood vessels called veins. Sometimes, a kidney tumour can grow directly into these nearby veins. When this happens, surgeons must carry out a complex, major operation to remove both the kidney and the tumour tissue inside the blood vessels.

This clinical study, known as NAXIVA, is looking at whether a drug called axitinib can help. Axitinib is a targeted cancer treatment that comes as a tablet. It works by blocking specific proteins that tumours rely on to grow and create their own blood supply. Doctors hope that by giving axitinib before surgery, the tumour in the veins will shrink.

If the medicine successfully shrinks the tumour, the planned operation may become less complicated and safer to perform. This could mean less strain on the body, a lower risk of complications during surgery, and an easier recovery afterwards.

Studies like this are vital for improving cancer care. They help NHS doctors learn whether using targeted medicines before an operation can safely change how surgery is done, offering patients better outcomes and gentler treatments in the future.

Key takeaways

Tests whether the drug axitinib can shrink kidney tumours in blood vessels before surgery.
Aims to make the planned operation smaller, simpler, and safer.
For adults aged 18 and over with clear cell kidney cancer planning to have surgery.
Treatment involves taking tablets twice daily for several weeks before the operation.
Taking part is completely voluntary and will not compromise your normal care.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with clear cell renal cell cancer that has grown into the main kidney vein or the large vein leading back to the heart. You must already be considered suitable and willing to have surgery to remove the tumour.

To join, you need to be in reasonable general health and able to carry out your everyday activities, such as light housework or desk work. Your kidneys also need to be working well enough, which doctors will check using simple blood and urine tests to measure kidney function and protein levels.

You will not be able to join if you are unable to have surgery, if your kidney function is too low, or if your urine contains high levels of protein. Women who could become pregnant will need a negative pregnancy test before starting 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.

I am aged 18 or older.
I have been diagnosed with clear cell kidney cancer.
My cancer has grown into my main kidney vein or central vein.
I am fit enough for and planning to have surgery to remove the tumour.
I am well enough to walk and carry out my own daily care.

Answer every question to see your result.

What does participation involve?

If you take part, you will be given axitinib tablets to take by mouth twice a day for a set number of weeks before your planned operation. During this time, you will visit the hospital for regular check-ups, including blood tests, urine tests, and blood pressure checks to make sure you are tolerating the drug well. You will also have scans, such as a CT or MRI scan, so doctors can see if the tumour in your vein has shrunk. After completing the course of tablets, you will have your surgery as planned. Doctors will continue to monitor your recovery and health with routine follow-up appointments after your operation. The total time on the drug is short, usually lasting a few weeks leading up to surgery, followed by standard surgical recovery checks.

Potential risks and benefits

Taking part may help shrink your tumour before surgery, which could make your operation simpler and safer, though this cannot be guaranteed. Axitinib can cause side effects, including high blood pressure, tiredness, loose stools, mouth soreness, and feeling sick. Your clinical team will monitor you closely and can give you treatments to help manage any side effects. Taking part is completely voluntary. You are free to leave the study at any time, and doing so will not affect your relationship with your healthcare team or the standard of care you receive.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Addenbrooke's Hospital
Unverified
Cambridge, England
Beatson West of Scotland Cancer Centre
Unverified
Glasgow, Scotland
Western General Hospital
Unverified
Edinburgh, Scotland
Royal Marsden
Unverified
London, England
St George's Hospital
Unverified
London, England
Broomfield Hospital
Unverified
Chelmsford, England
The Royal Free Hospital
Unverified
London, England

Common questions

What is axitinib and how do I take it?

Axitinib is a targeted cancer therapy that blocks blood supply to cancer cells. It comes as a tablet that you swallow twice a day.

Will I still need an operation if the drug works well?

Yes. The aim of the drug is to shrink the tumour to make surgery safer and easier, not to replace the operation altogether.

What happens if the tumour does not shrink?

Your team will monitor your progress closely with scans. If the tumour does not shrink, you will still proceed with your planned surgery.

Do I have to pay to take part in this trial?

No. Clinical trials in the UK are funded, and the trial medication and extra study tests are provided free of charge.

Can I leave the study if I change my mind?

Yes. You can leave the trial at any point without giving a reason, and you will continue to receive standard NHS cancer care.

How to find out more

Kathleen Riddle

Official trial record

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