RecruitingPHASE2INTERVENTIONAL

Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma

This study is investigating a new treatment called 'irinotecan-ChemoSeed' for an aggressive brain tumour called glioblastoma. After surgery to remove the tumour, tiny seeds containing a cancer-fighting drug (irinotecan) are placed into the space left behind. The idea is for these seeds to slowly release the drug directly where the tumour was, aiming to kill any leftover cancer cells and prevent the tumour from returning. Part 1 of the study looked at the safest dose of these seeds. Part 2 will compare this new treatment combined with standard care (like radiotherapy and chemotherapy) to standard care alone, to see if it works better at stopping the tumour from coming back or growing.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

CRISM Therapeutics LTD

Enrolment target

147

Start

20 Aug 2026

Estimated completion

01 Dec 2029

Glioblastoma

What is this study about?

Imagine you have a brain tumour called glioblastoma, which is a very serious type of cancer. Doctors usually try to remove as much of it as possible with surgery. But even after surgery, tiny cancer cells can sometimes be left behind, which can cause the tumour to grow back.

This study is looking at a new way to try and tackle these leftover cells. It involves using something called 'irinotecan-ChemoSeed'. These are very small, rice-sized implants that contain a strong cancer medicine called irinotecan. After the surgeon removes the main tumour, these little seeds are carefully placed into the space where the tumour used to be. The idea is that they slowly release the medicine directly into that area, aiming to kill any hidden cancer cells that might be left behind, without affecting the rest of the body as much.

This research is happening in two main parts. The first part was a smaller study to figure out the safest amount of these seeds to use. The second, larger part of the study will compare this new treatment (the seeds plus regular care like radiotherapy and chemotherapy) to just having the regular care. The aim is to see if adding these seeds can help people live longer or stop the tumour from returning for a longer time.

Key takeaways

This study is testing a new way to treat glioblastoma brain tumours.
It involves placing small drug-releasing implants ('ChemoSeeds') after surgery.
The goal is to kill leftover cancer cells and prevent the tumour from returning.
This new treatment is compared to standard care (surgery, radiotherapy, chemotherapy).
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to meet certain requirements. For example, if you've already had glioblastoma and it's come back (Part 1), or if you've just been diagnosed with it (Part 2), and your doctors believe surgery could remove it.

Generally, you would need to be 18 years or older and be well enough to take part. This means your body's organs, like your kidneys and liver, would need to be working properly, and your blood counts would need to be at a healthy level. You should also be able to understand what the study involves and be willing to sign a consent form.

There are also reasons why someone might not be able to join, such as if the tumour is in many different places in the brain, or if it has spread to the lining of the brain. You would also need to use effective contraception if you are a woman who could become pregnant, or if you are a man whose partner could become pregnant, for a certain period during and after 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 newly diagnosed glioblastoma or has it returned?
Are doctors able to surgically remove your tumour?
Is your general health and organ function (like kidneys, liver, blood counts) good?
Are you able to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have surgery to remove your brain tumour. After the surgeon removes the tumour, if you are in the new treatment group, tiny 'ChemoSeeds' containing the study drug would be placed into the area where the tumour was. You would then receive standard treatments like radiotherapy (targeted radiation) and chemotherapy (cancer drugs) in the weeks following your surgery, just as you normally would.

For those in Part 2 of the study, you would be randomly assigned to either receive the ChemoSeeds alongside standard care or to receive standard care only. This is like flipping a coin, so it's fair. You would have regular appointments and tests to check your health, how well the treatment is working, and to make sure you're not experiencing any unexpected side effects. The exact number of visits and the total duration would depend on your individual treatment plan and how long your medical team monitors your health after treatment.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new treatment that could potentially improve how long you live or delay the return of your tumour, beyond what standard treatments might achieve. However, as with any medical treatment, there are also potential risks. The new 'ChemoSeeds' might cause side effects, some of which we might not fully understand yet. Your medical team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a very serious and fast-growing type of brain tumour that starts in the brain or spinal cord.

What are 'ChemoSeeds'?

They are tiny, rice-sized implants that contain a cancer medicine. They are placed where a brain tumour was removed to slowly release the medicine and kill any remaining cancer cells.

What is 'Standard of Care' (SoC)?

Standard of Care refers to the usual and most effective treatments doctors currently use for a specific condition, like surgery, radiotherapy, and chemotherapy for glioblastoma.

Will I know if I'm getting the new treatment or just standard care?

In the main part of the study (Part 2), participants are randomly assigned to either group. This is like a lottery, and you might not know which treatment you are getting, to keep the study fair and unbiased.

Can I stop participating if I want to?

Yes, absolutely. You can decide to leave the study at any point, and it will not affect the quality of your future medical care.

How to find out more

Chris McConville, Pr

chrismcconville@extrudedpharmaceuticals.com +44 (0) 78342 67819 Official trial record

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