ABC-12: The microbiome in biliary tract cancer
Research type
Research Study
Full title
Exploring the microbiome in patients with advanced biliary tract cancer in a first-line study of durvalumab (MEDI4736) in combination with cisplatin/gemcitabine
IRAS ID
1005274
Contact name
Clare Griffin
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Eudract number
2022-000799-20
ISRCTN Number
ISRCTN11210442
Research summary
The aim of this study, known as ABC-12 is to analyse the bacteria that normally live in the bowel and mouth.
This research study is designed to:
1. Identify which microbiomes (bacteria) are present and how many of them are there.
2. Try to find out if a difference in the number of bacteria in your gut has any effect on how you respond to an new anti-cancer immunotherapy drug durvalumab in combination with standard chemotherapy drugs used to treat biliary tract cancer, cisplatin and gemcitabine.
3. Identify if the number of bacteria has any effect on when your treatment stops working or on how long you live.
Researchers have found that sometimes the body’s own immune system may slow down or control cancer growth. Sometimes this natural immune system response stops and the cancer is not killed by your own immune system and in some patients, cancer cells and immune cells start to express signals that stop the body’s immune system from killing the cancer.
In this study, a new drug will be used, durvalumab, to try and block this signal to increase the immune response, in combination with standard of care cisplatin/gemcitabine chemotherapy. Durvalumab is an antibody (a protein produced by the body’s defense system) and it is hoped that by blocking this signal, the immune cells will once again be able to prevent or slow down cancer growth. This drug combination has been shown in a large clinical trial to increase survival in patients with BTC where surgery is not an option.The aim will be to recruit 70 patients across 10 UK sites over 12 months, with a 12 month follow up period.
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0389
Date of REC Opinion
3 Aug 2023
REC opinion
Further Information Favourable Opinion