An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas
This research study is about finding better ways to treat pancreatic cancer that has spread to other parts of the body and hasn't yet received chemotherapy. Doctors are comparing two different treatment combinations. One combination includes a new drug called irinotecan liposome, along with oxaliplatin and 5-fluorouracil/leucovorin. The other is a standard treatment consisting of nab-paclitaxel and gemcitabine. The main aim is to see if the new combination helps people live longer than the standard treatment. The study will also look at how long people live without their cancer growing and how well the treatment shrinks the cancer. This is a Phase III study, which means it's a key step in checking if a new treatment is effective and safe compared to existing options.
At a glance
What is this study about?
This study is for people who have been diagnosed with pancreatic cancer that has spread to other parts of the body. This type of cancer is called 'metastatic', and it means the cancer cells have travelled from the pancreas to other areas of the body. It's also for people who haven't had any chemotherapy treatment for their cancer yet.
The main purpose of this study is to compare two different approaches to treating this type of pancreatic cancer. One approach uses a combination of medicines that includes a newer drug called irinotecan liposome, along with other chemotherapy drugs like oxaliplatin and 5-fluorouracil/leucovorin. The other approach uses a combination of two well-known chemotherapy drugs: nab-paclitaxel (often called Abraxane) and gemcitabine. Doctors want to find out if the newer drug combination is more effective at helping people live longer.
By carefully comparing these two treatment groups, researchers hope to identify which treatment provides the best outcome for patients. This kind of study, called a Phase III trial, is a crucial step in developing new and improved treatments. If the new combination proves to be more effective, it could become a new standard treatment option for people with metastatic pancreatic cancer.
Key takeaways
- This study is for advanced pancreatic cancer that hasn't had chemotherapy.
- It compares a new treatment combination against a standard one.
- The main aim is to see if the new treatment helps people live longer.
- Participants will be randomly assigned to one of two treatment groups.
- Close medical monitoring will be provided throughout the study.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.
Participants must have pancreatic cancer that has spread to other parts of the body. This is sometimes called 'advanced' or 'metastatic' pancreatic cancer. Importantly, you should not have received any chemotherapy for your pancreatic cancer before joining this study.
There will be other detailed health checks to make sure the study is safe and appropriate for you, which a doctor and study team will discuss with you. These checks are important to ensure your safety and that the study results are clear.
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 pancreatic cancer that has spread to other parts of your body?
- Have you not received any chemotherapy for your pancreatic cancer before?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive one of the two treatment combinations described. Neither you nor your doctor will get to choose which treatment you receive; it will be decided randomly, like flipping a coin. You will have regular appointments at the hospital or clinic for your treatments and check-ups. These visits will involve various assessments, such as blood tests, scans (like CT scans or MRI scans), and physical examinations to see how you are responding to the treatment and to monitor your health.
The medication will be given as an infusion, which means it goes into your bloodstream through a drip. The study team will explain exactly how often and for how long you'll receive these treatments. Following the main treatment period, there will be follow-up appointments to track your health and the progress of your cancer over time. The total duration of your participation in the study, including follow-up, will be explained by the study team, but typically these kinds of studies monitor participants for a substantial period.
Potential risks and benefits
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Common questions
What is 'metastatic adenocarcinoma of the pancreas'?
It means you have pancreatic cancer that has spread from the pancreas to other parts of your body.
What does 'chemotherapy naive' mean?
It means you haven't received any chemotherapy treatment for your pancreatic cancer yet.
Will I know which treatment I'm getting?
No, you will be randomly assigned to one of the two treatment groups, so neither you nor your doctor will choose.
What are the main goals of this study?
The main goal is to see if one treatment helps people live longer than the other, and to check how well it shrinks the cancer.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, and it won't affect your regular medical care.
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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