A phase 1/2a study to evaluate the dose, safety, tolerability, and efficacy of an intraperitoneal α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis from colorectal carcinoma following hyperthermic intraperitoneal chemotherapy
This research is testing a new treatment called Radspherin® for people with bowel cancer that has spread to the lining of their abdomen, a condition known as peritoneal carcinomatosis. This early-stage study (Phase 1/2a) is designed to find the right dose of Radspherin®, check for any side effects, and see how well it works. Participants will have already undergone a specific surgery and chemotherapy treatment called hyperthermic intraperitoneal chemotherapy (HIPEC). The aim is to understand if this new radioactive medicine, given directly into the tummy, can help manage the cancer. It's a first step to see if this treatment could be an option in the future.
At a glance
What is this study about?
This study is trying out a new medicine, called Radspherin®, for people who have bowel cancer that has spread to the lining of their tummy. This spread is known as 'peritoneal carcinomatosis'. Doctors want to see if this new treatment can help after patients have already had a special kind of surgery and chemotherapy, which involves heating the chemotherapy and washing it directly into the abdomen.
This is an early stage of testing for Radspherin® in people. It's called a 'Phase 1/2a' study. This means the main goals are to find out if the treatment is safe, what dose works best without causing too many problems, and if it has any positive effects on the cancer. It's a crucial step in understanding whether this medicine could become a useful treatment in the future.
The medicine, Radspherin®, is a special type of radioactive treatment. It's given directly into the tummy (this is called 'intraperitoneal'). The idea is that it will target and treat the cancer cells where they have spread. By taking part, you could help doctors learn more about this new approach and potentially help others with similar conditions in the future.
Key takeaways
- This study is testing a new radioactive treatment for advanced bowel cancer.
- It's for cancer that has spread to the lining of the tummy (peritoneal carcinomatosis).
- Participants will have already had a specific surgery and heated chemotherapy (HIPEC).
- It's an early-stage trial focusing on safety, dose, and early signs of effectiveness.
- The treatment is given directly into the abdomen.
- Taking part could help further medical understanding of this condition.
Who may be eligible?
To be able to take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
You would also need to have bowel cancer that has spread to the lining of your tummy. Importantly, you would have already undergone a specific surgery and chemotherapy treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) before joining this study.
There will be other detailed criteria that your doctor will check to ensure this study is right for you and safe. These usually include things like your overall health, other medical conditions you might have, and results from blood tests and scans.
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 old or older?
- Do you have bowel cancer that has spread to the lining of your tummy?
- Have you already had surgery and a heated chemotherapy treatment called HIPEC?
- Are you generally well enough to consider a new treatment?
- Are you able to attend regular clinic visits and appointments?
What does participation involve?
If you decide to take part, you will receive the study medicine, Radspherin®, which will be given directly into your tummy. The research team will regularly check how you are doing, including monitoring for any side effects and seeing how your body is responding to the treatment.
This will involve several visits to the clinic for medical check-ups, blood tests, and scans over a period. The exact number and frequency of these visits, as well as the total length of time you would be in the study, will be fully explained by the study team. They will also tell you about any follow-up appointments after you finish receiving the main treatment.
Potential risks and benefits
Locations (2)
- —UnverifiedSweden
- —UnverifiedNorway
Common questions
What is peritoneal carcinomatosis?
It's when bowel cancer has spread to the thin lining that covers the organs inside your tummy (abdomen).
What is HIPEC?
HIPEC stands for Hyperthermic Intraperitoneal CHEmotherapy. It's a treatment where heated chemotherapy liquid is washed directly into your abdomen after surgery.
What does 'intraperitoneal' mean?
It means the medicine is given directly into your abdomen, into the space around your organs, rather than through a vein or by mouth.
What does Phase 1/2a mean?
It means this is a very early study. Doctors are first checking if the treatment is safe and what dose to give, and then beginning to look for signs that it might be effective.
Will I receive radiation in this treatment?
Yes, Radspherin® is a special type of 'radioactive' medicine, also called an alpha-emitting radionuclide therapy, designed to target cancer cells.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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