Assessing the impact of mouth and bowel bacteria on outcomes of patients receiving chemotherapy with immunotherapy

Background and study aims
The aim of this study, known as ABC-12, is to analyse the bacteria that normally live in the bowel and mouth. The aim is to try and find out whether this has an effect on how well biliary tract cancer (BTC) (cancer of the bile ducts and liver) responds to treatment and how long life expectancy will be. 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.
Who can participate?
Adult patients with confirmed unresectable (cannot be removed by surgery) advanced or metastatic cancer of the biliary tract, including cholangiocarcinoma and gallbladder carcinoma
What does the study involve?
The aim will be to recruit 70 patients across 10 UK sites over 12 months, with a 12 month follow up period.