Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
This study is investigating a new treatment approach for advanced pancreatic, liver (hepatocellular), and bile duct cancers. It combines newer medicines called immunotherapy (Durvalumab and Tremelimumab) with an existing medicine, propranolol, which is often used for other conditions like heart issues. For some types of cancer, standard chemotherapy will also be given alongside these drugs. This is a Phase 2 study, meaning researchers are looking at how well this combination works and if it's safe for patients. The goal is to find better ways to treat these cancers, particularly when they are advanced and can't be removed by surgery. Patients need to meet specific health requirements to take part.
At a glance
What is this study about?
This clinical trial is designed for people who have advanced pancreatic cancer, liver cancer (specifically hepatocellular carcinoma), or bile duct cancer (also known as cholangiocarcinoma). These are cancers that doctors cannot treat with surgery or other local treatments. The study aims to see if a new combination of medicines can help. We're looking at two types of immunotherapy, named Durvalumab and Tremelimumab, which help your body's immune system fight cancer cells. These are given along with Propranolol, a medicine that's been used for a long time for things like high blood pressure, but we are now exploring if it can also help in cancer treatment.
For some patients, traditional chemotherapy drugs like Gemcitabine, Nab-paclitaxel, or Cisplatin will also be part of the treatment plan. The study is a 'single-arm' study, meaning everyone in the study will receive this new combination treatment. It's a 'Phase 2' study, which means we're primarily focused on understanding how safe this new combination is and how well it works to shrink or stop the growth of the cancer.
The hope is that by combining these different types of medicines, we might find a more effective way to treat these specific advanced cancers, potentially helping patients live longer and with a better quality of life. The study carefully monitors patients to understand the effects of the treatment.
Key takeaways
- This study is for advanced pancreatic, liver, or bile duct cancers.
- It combines immunotherapy (Durvalumab, Tremelimumab) with Propranolol.
- Chemotherapy is also included for some cancer types.
- The main goals are to check the new combination's safety and effectiveness.
- You will be closely monitored with regular hospital visits and tests.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you must be at least 18 years old and weigh more than 30 kilograms (about 4 stone 10 pounds). You need to have been diagnosed with advanced pancreatic, liver (hepatocellular), or bile duct cancer that can't be cured by surgery or local treatments. Your doctors will confirm the exact type of cancer.
You should also be generally well enough to participate, meaning your everyday activities aren't too limited by your health. If you've recently had radiation therapy, you need to have finished it at least 4 weeks before starting the study drugs, and any side effects from it should have mostly cleared up. You must also be able to understand the study and agree to take part.
Important for women: If you could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during and for 6 months after the study. Men of childbearing potential also need to use effective birth control. These measures are taken to ensure safety, as the study drugs might affect an unborn baby.
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 advanced pancreatic, liver, or bile duct cancer that can't be removed by surgery?
- Are you generally well and active enough for daily activities?
- If you are a woman who could become pregnant, are you willing to use effective birth control?
- Are you able to understand the study information and agree to take part?
What does participation involve?
If you join this study, your treatment plan will depend on your specific type of cancer. For example, if you have pancreatic cancer, you'll receive Durvalumab every 4 weeks, a combination of chemotherapy drugs on specific days, and Propranolol every day. If you have liver cancer, you'll get Durvalumab every 4 weeks and daily Propranolol. For bile duct cancer, Durvalumab will be given every 3 weeks, along with chemotherapy on specific days, and daily Propranolol.
All participants will receive Tremelimumab once at the beginning of the study, and possibly again later if your cancer gets worse. During the study, you'll have regular hospital visits for treatment, blood tests, and scans to check how you're doing and how the treatment is affecting your cancer. These visits are essential for your safety and to gather important information about the treatment's effectiveness. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will be closely monitored throughout.
Potential risks and benefits
Locations (1)
- Cross Cancer InstituteVerified postcodeEdmonton, Canada· Recruiting
Common questions
What is immunotherapy?
Immunotherapy is a type of treatment that uses medicines to help your body's own immune system find and fight cancer cells more effectively.
What is Propranolol and why is it being used?
Propranolol is a common medicine often used for heart problems or anxiety. In this study, researchers are exploring if it can also help make cancer treatments like immunotherapy more effective.
Is this a new treatment, or has it been used before?
The individual medicines (immunotherapy, chemotherapy, propranolol) are known, but this specific combination for these cancers is new and is being tested to see if it works well together.
What happens if the treatment doesn't work for me?
Your doctors will regularly check your progress. If the treatment isn't working or if you have too many side effects, they will discuss other treatment options with you and you can leave the study.
How long will I be in the study?
The duration of your participation will depend on how you respond to the treatment and your general health, but you will be monitored closely for as long as you are on the study treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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