Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
This research study, called GASPAR, is looking into a new way to treat stomach cancer (gastric cancer) that can be completely removed with an operation. The study combines a newer drug called spartalizumab with a well-known chemotherapy treatment called FLOT. The main goal is to find out if this combination treatment can make the cancer disappear more completely from the removed stomach tissue during surgery. Researchers will also be looking at how long people live without their cancer coming back, how long they live overall, and how well the treatment helps remove all cancer cells around the edges of the surgery area. They will also keep a close eye on any side effects and how safe the treatment is.
At a glance
What is this study about?
This study is called GASPAR, and it's looking into a new way to treat stomach cancer that can be removed with surgery. Stomach cancer is also sometimes called gastric cancer. When doctors say "resectable," it means the cancer can be completely taken out by an operation.
In this study, doctors are combining a new drug called spartalizumab with a standard chemotherapy treatment known as FLOT. FLOT is a mix of different chemotherapy medicines: fluorouracil, leucovorin, oxaliplatin, and docetaxel. Spartalizumab is a type of immunotherapy, which helps your body's own immune system fight cancer. The researchers want to see if adding spartalizumab to FLOT can make the cancer shrink much more before surgery, potentially making the surgery more successful or even making the cancer disappear completely from the tissue that's removed.
The main thing the doctors are measuring is how many people have their main tumour completely disappear in the tissue that is removed during surgery. This is an important sign that the treatment is working well. They will also be looking at how long people stay healthy without their cancer returning, how long people live overall, and how safe the new combination treatment is by checking for any side effects.
Key takeaways
- This study combines a new immunotherapy drug (spartalizumab) with standard chemotherapy (FLOT) for stomach cancer.
- It's for stomach cancer that can be removed with surgery.
- The main aim is to see if the combination treatment can make the cancer disappear completely from the tissue removed during surgery.
- Researchers will also track how long people stay cancer-free and their overall survival.
- Safety and side effects of the new treatment combination will be carefully monitored.
Who may be eligible?
This study is open to both men and women who are at least 18 years old. There is no upper age limit, so older adults may also be able to take part.
To be considered for this study, you must have been diagnosed with stomach cancer that your doctor believes can be completely removed with an operation. Your medical team will need to confirm that you meet all the specific health requirements for the study, which include certain blood test results and a general good level of health.
There might be other conditions that mean you can't join the study, such as having certain other health problems or if you've had specific treatments in the past. Your doctor will carefully review your full medical history to see if this study is suitable for you.
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?
- Have you been diagnosed with stomach cancer?
- Has your doctor told you your stomach cancer can be removed by surgery?
- Are you generally in good health, apart from your cancer?
What does participation involve?
If you decide to take part in this study, you'll receive the combination treatment of spartalizumab and FLOT before your surgery. This will involve regular visits to the hospital for your medication. During these visits, the study team will carry out various checks, including blood tests, physical exams, and scans, to see how you're responding to the treatment and to monitor your health.
After your surgery, you will continue to have follow-up appointments. These appointments will involve check-ups and possibly more scans to see if your cancer has returned. The study will monitor your health for a long time after your treatment ends to understand the long-term effects of the new combination. The exact number of visits and the total duration in the study will be explained in detail by the study team, but typically, clinical trials involve regular check-ups for several years.
Potential risks and benefits
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Common questions
What is 'resectable gastric cancer'?
This means stomach cancer that doctors believe can be fully removed with surgery.
What is FLOT?
FLOT is a standard chemotherapy treatment that uses a combination of four different medicines to fight cancer.
What is spartalizumab?
Spartalizumab is a type of immunotherapy, a newer drug that helps your body's immune system recognise and attack cancer cells.
What does 'pCR' mean?
pCR stands for 'pathological complete response.' In this study, it means that no cancer cells are found in the stomach tissue that is removed during surgery.
Will I still have surgery if I join this study?
Yes, this study is designed for people whose stomach cancer can be removed with surgery, and the treatment before surgery is being tested to improve the surgical outcome.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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