Phase 2 Study of Preoperative Gemcitabine Plus Cisplatin with Durvalumab (MEDI4736) and Tremelimumab in intrahepatic cholangiocarcinoma (NeoTreme)
This research study is looking at a new way to treat a specific and rare type of liver cancer called intrahepatic cholangiocarcinoma. Doctors are testing a combination of established chemotherapy drugs, gemcitabine and cisplatin, along with two newer immunotherapy drugs, Durvalumab (Imfinzi) and Tremelimumab (Imjudo). These medicines are given before surgery. The main goal is to find out if this combination can increase the chances of a successful surgery where all or most of the cancer is removed. Researchers will also look at how patients respond to the treatment, any side effects, and how it affects their quality of life.
At a glance
What is this study about?
This study is called 'NeoTreme' and it's looking into a new treatment approach for a rare form of liver cancer called intrahepatic cholangiocarcinoma. This type of cancer starts inside the liver's bile ducts. When doctors treat this cancer, surgery to remove the tumour is often the best option. However, sometimes the tumour is too large or too difficult to remove completely.
In this study, doctors are giving a combination of medicines *before* surgery. The medicines include two chemotherapy drugs, gemcitabine and cisplatin, which are commonly used to treat cancer. They will also be giving two other drugs, Durvalumab (known as Imfinzi) and Tremelimumab (known as Imjudo). These are a type of medicine called immunotherapy, which works by helping your body's own immune system fight the cancer cells. The hope is that by giving these drugs before surgery, the tumour might shrink, or become easier for surgeons to remove completely. This is very important because successfully removing the tumour can lead to better long-term outcomes for patients.
This is a Phase 2 study, which means it’s an earlier stage of research. It's designed to see if the treatment works well enough to be tested in a larger group of people later. Researchers will be carefully checking how many patients have their tumour completely or mostly removed after this treatment, how safe the treatment is, and how it affects patients' overall well-being and recovery after surgery.
Key takeaways
- This study tests new drugs for a rare liver cancer before surgery.
- It combines chemotherapy with newer immunotherapy to help surgery success.
- The main goal is to see if more of the cancer can be removed.
- It's an early-stage study, designed to assess how well and safely it works.
- Participation involves ongoing hospital visits, treatments, and follow-ups.
Who may be eligible?
To be considered for this study, you would generally need to be an adult, 18 years old or older. There is no upper age limit for taking part, so people of many ages could be suitable.
Both men and women are welcome to participate in this research. The study aims to gather information that is relevant to everyone with this condition, regardless of their gender.
Beyond age and gender, there will be other specific medical checks to make sure the study treatment is safe for you and that your health condition allows you to participate effectively. For instance, doctors will need to confirm you have intrahepatic cholangiocarcinoma and that surgery is a potential treatment option for you. They will also check your general health, organ function, and current medicines to make sure there are no other reasons why the study might not be right for you.
- Are you 18 years old or older?
- Have you been diagnosed with intrahepatic cholangiocarcinoma?
- Are you potentially able to have surgery for your cancer?
- Are you generally well enough to undergo cancer treatment and surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve several visits to the hospital for treatment, check-ups, and tests. You would receive the combination of medicines (gemcitabine, cisplatin, Durvalumab, and Tremelimumab) over a period of time before your planned surgery. These medicines are given as infusions, meaning they are delivered directly into your bloodstream through a drip.
During the study, doctors and nurses will regularly review your health. This will include blood tests, scans (like CT or MRI), and other examinations to see how you are responding to the treatment and to monitor for any side effects. After the treatment period, you would have your planned surgery. Following surgery, you would have follow-up appointments and tests to track your recovery, your health, and the long-term effects of the treatment. The total duration of your involvement could be several months or longer, including the treatment period, surgery, and follow-up care.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is intrahepatic cholangiocarcinoma?
It's a rare type of cancer that starts in the bile ducts inside your liver.
What kind of medicines will I receive?
You'll get chemotherapy drugs (gemcitabine, cisplatin) and immunotherapy drugs (Durvalumab, Tremelimumab) before surgery.
Why are they giving drugs before surgery?
The aim is to shrink the tumour or make it easier to remove completely during surgery.
Is this a new treatment?
Yes, this specific combination of drugs before surgery for this cancer type is being tested in this study.
How long will I be in the study?
Your involvement would include the treatment period before surgery, the surgery itself, and follow-up visits, which could last several months or more.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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