A new clinical trial, sponsored by UCL and UCLH, aims to extend survival for some patients with cancer in the biliary tract by treating them with therapies specifically tailored to the genetic profile of their tumour.
Bile duct cancer, also called cholangiocarcinoma, is a type of cancer that starts in the bile ducts, small tubes that connect the liver and gallbladder to the small bowel. They carry a fluid called bile that helps to break down fat from the food we eat, making it easier to digest.
The UK arm of the new SAFIR-ABC10 trial will be sponsored by UCL and run through the Cancer Research UK (CRUK) and UCL Cancer Trials Centre as well as UCLH.
Patients diagnosed with the three main types of bile duct cancer (intrahepatic, perihilar or distal cholangiocarcinoma) or with cancer of the gallbladder may be eligible for participation in the SAFIR-ABC10 trial.
They will have their tumours genetically profiled and will then be offered one or more of seven different anti-cancer therapies best matched to their tumour profile.
Professor John Bridgewater, UCL Cancer Institute clinical researcher and UCLH consultant medical oncologist, who will lead the UK arm of the trial, said: "These cancers are becoming more common. With the current standard of care, patients typically only live for one year after treatment begins. So it has become increasingly more urgent for us to try to identify more innovative and effective alternative treatment options."
Standard treatment for advanced biliary tract cancer is based on chemotherapy, and more recently, supplemental immune therapy.
The international study - led by the French hospital network Unicancer, with chief investigator Dr David Malka, medical oncologist at the Institut Mutualiste Montsouris in Paris - aims to recruit some 800 participants from all over the world and offer them therapies tailored to the genetic make-up of their tumour.
Dr Malka said: "This is the first precision medicine study for patients with cancer in the biliary tract and the first time this patient group will be offered these anti-cancer therapies.
"Genomic profiling of patients has been possible for some time but, in the past, there was little we could do with the results of this profiling. The SAFIR ABC10 study resolves this problem by providing seven different therapies which we can match up with the specific 'targets' found in each patient's tumour."
Dr Tayyaba Jiwani, science engagement manager at Cancer Research UK, commented: "The outlook for people with biliary tract cancers is often poor, because they are typically diagnosed late with few treatment options other than chemotherapy.
"There is a pressing need for new treatment avenues and through SAFIR ABC-10, we're proud to support one of the first precision medicine trials for biliary tract cancers. With trials like SAFIR ABC-10, we're accelerating the development of more personalised, genetically targeted treatments that are more likely to be effective against cancer, so that more people can live longer, better lives free from the fear of this disease."
Helen Morement, CEO of AMMF - The Cholangiocarcinoma Charity, said: "After many years of very few therapies for those diagnosed with an inoperable cholangiocarcinoma, there have been some notable advances recently. Importantly, the inclusion of the immunotherapy durvalumab to the long-established standard of care first line chemotherapy combination gemcitabine and cisplatin, and the recent introduction of molecular (genomic) profiling which enables the identification of targets in the patient's tumour which can be addressed by specific therapies. Excitingly, SAFIR ABC-10 is a first line study which harnesses both of these advances."
For UK participants, genetic screening will be carried out by the NHS North Thames Genomic Laboratory Hub.
The trial also involves digestive oncology groups called the National Cancer Research Institute Upper GI Group (UK), PRODIGE (France) and the Belgian Group of Digestive Oncology (Belgium).
