A randomized non-comparative phase II study of Maintenance therapy with OSE2101 plus FOLFIRI, or FOLFIRI after induction therapy with FOLFIRINOX in patients with locally advanced or metastatic Pancreatic ductal adenocarcinoma.
This research is a Phase II study for people with advanced pancreatic cancer that has spread or is locally advanced. After an initial course of chemotherapy (FOLFIRINOX), participants will either receive a combination of the new drug OSE2101 with another chemotherapy called FOLFIRI, or they will receive FOLFIRI on its own. The main purpose of this study is to compare these approaches, focusing on how long people live after starting treatment. Researchers will also look at side effects, how well the cancer responds, and overall quality of life. This helps doctors understand better ways to treat this type of cancer.
At a glance
What is this study about?
This study is designed for individuals diagnosed with pancreatic cancer that is considered advanced, meaning it has grown significantly in its original location or has spread to other parts of the body. The aim is to find out if adding a new medicine, OSE2101, to a standard chemotherapy treatment (FOLFIRI) works better than giving FOLFIRI chemotherapy on its own. Both groups will have first received a strong initial chemotherapy called FOLFIRINOX.
This is a 'Phase II' study, which means it’s still in the earlier stages for this new drug. Doctors are trying to see if the new combination shows promise and whether it's safe enough to consider for larger future studies. The main thing they will be looking at is how long people live after they start treatment in the study. They also want to understand the side effects and how people's quality of life is affected, to make sure treatments are as effective and comfortable as possible.
By comparing these different ways of continuing treatment after the initial chemotherapy, researchers hope to discover improved strategies for managing advanced pancreatic cancer. The information gathered from this study will help healthcare professionals make better informed decisions about future treatments, ultimately working towards better outcomes for patients.
Key takeaways
- This study aims to discover better treatments for advanced pancreatic cancer.
- It combines a new drug (OSE2101) with standard chemotherapy, or uses chemotherapy alone.
- Researchers will monitor how long people live, side effects, and quality of life.
- It is a Phase II study, exploring the safety and effectiveness of the new drug.
- Both men and women aged 18 and over can participate if they meet specific health criteria.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
You would need to have specific types of advanced pancreatic cancer, as described in the study. Your medical team would carry out tests to confirm this and ensure you meet all the necessary health criteria for participating in a clinical trial.
There might be other health requirements that your doctor will discuss with you to ensure your safety throughout the study.
- Are you 18 years old or older?
- Have you been diagnosed with locally advanced or metastatic pancreatic cancer?
- Are you able to undergo chemotherapy treatments?
- Are you willing to have regular hospital visits and check-ups?
- Are you prepared for blood tests and scans as part of the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would first receive a specific chemotherapy treatment called FOLFIRINOX. After this, you would be put into one of two groups: one group would receive a new drug called OSE2101 along with FOLFIRI chemotherapy, and the other group would receive FOLFIRI chemotherapy on its own. Both OSE2101 and FOLFIRI are given as injections or through a drip.
You would have regular visits to the hospital or clinic for your treatments and check-ups. During these visits, doctors and nurses would monitor your health, check for any side effects, and carry out tests like blood tests and CT scans to see how you are responding to the treatment. You might also fill out questionnaires about how you are feeling and your quality of life.
The total length of time you would be in the study would depend on how your treatment progresses and your individual response. Follow-up will continue even after treatment finishes, to understand the long-term effects.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is 'locally advanced or metastatic Pancreatic ductal adenocarcinoma'?
This refers to pancreatic cancer that has either grown beyond the pancreas but hasn't spread to distant parts of the body (locally advanced) or has spread to other organs (metastatic).
What does a 'Phase II study' mean?
A Phase II study is an early stage of clinical research where doctors test a new treatment on a small group of people to see if it's safe and if it shows any signs of working for a particular condition.
What is FOLFIRI and FOLFIRINOX?
These are specific combinations of chemotherapy drugs commonly used to treat pancreatic cancer.
What is the new drug OSE2101?
OSE2101 is an experimental drug being tested to see if it can improve treatment outcomes for pancreatic cancer when combined with chemotherapy.
Will I know which treatment I am getting?
In this specific study, once you've had the initial FOLFIRINOX, you will be randomly assigned to receive either OSE2101 plus FOLFIRI, or FOLFIRI alone. This is done by chance to fairly compare the treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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