Current Cholangiocarcinoma Trials
Listed here are the clinical trials for those with cholangiocarcinoma (bile duct cancer) or gall bladder cancer, currently open and recruiting in the UK.
Wherever possible links for further information have been included to follow up for more information and to check eligibility. Each trial has specific eligibility criteria, so if you are interested in taking part in one, please discuss with those running the trial (contact details are given where possible) and/or your consultant.
Please note it is not appropriate for AMMF to give medical advice or recommendations, and all details provided are for information purposes only.
Molecular Profiling and Targeted Therapies
Current scientific advances mean that cancer treatments are moving towards those more specifically targeting the tumour ‘drivers’, and ways to inhibit these drivers. Progress is beginning to be made in the understanding of cholangiocarcinoma and of genomic or molecular profiling, with trials being carried out to find target agents, in the search for better and more effective treatments.
Several of the clinical trials listed here are looking at targeted therapies and will require molecular profiling to be carried out first to see if a patient has the particular mutation or fusion which the therapy will act on.
Update 22 July 2021: NICE has now approved pemigatinib (Pemazyre®) for those with cholangiocarcinoma who have an FGFR2 fusion. Pemigatinib is the first ever targeted therapy approved for CCA. This approval will not only give those eligible patients in England and Wales access to an alternative to chemotherapy, but importantly this new NICE guidance now means molecular profiling will be mandated as standard of care and so opens the door for all those diagnosed with cholangiocarcinoma to have molecular testing carried out.
Update 07 February 2022: The Scottish Medicines Consortium (SMC) committee has now approved pemigatinib (Pemazyre®) for use by NHS Scotland for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion that has progressed after at least one prior line of systemic therapy.
For a short animated film “Cholangiocarcinoma and the importance of molecular testing” and a booklet, “ Molecular testing in cholangiocarcinoma”, click hereRead More
Following the outcome of the BILCAP study, those who have undergone a resection for their cholangiocarcinoma or gall bladder cancer, and who fit the eligibility criteria, are now offered Capecitabine chemotherapy as the standard of care.
The ACTICCA-1 trial is a randomised Phase III trial which looks to compare Gemcitabine and Cisplatin against Capecitabine alone (currently the standard treatment) for those who have had a resection for their cholangiocarcinoma or gall bladder cancer:
“Adjuvant Chemotherapy with Gemcitabine and Cisplatin compared to Capecitabine (standard treatment) after Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma”Read More
ABC-07 is a randomised trial for those with locally advanced cholangiocarcinoma. All patients begin by receiving Gemcitabine/Cisplatin chemotherapy and, after 6 cycles of chemotherapy, are then randomised to continuing with the chemotherapy or receiving SBRT (stereotactic body radiotherapy)*
* SBRT (stereotactic body radiotherapy) is a way of targeting radiotherapy beams very precisely at a tumour from many different directions. LINAC or Cyberknife machines may be used to deliver SBRT, depending on the equipment available in a particular hospital.Read More
FIGHT-302: Phase 3 Study of First-line Pemigatinib Versus Gemcitabine Plus Cisplatin for Cholangiocarcinoma With FGFR2 Fusions or Rearrangements.
This study will compare chemotherapy (CisGem) with an FGFR-inhibitor in FGFR-altered patients and will require prior analysis of a tumour biopsy to determine that there is the appropriate FGFR-alteration.Read More
A Phase II, Single Arm Study of BGJ398 (infigratinib) in patients with advanced cholangiocarcinoma.
Full title: “A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy”Read More
A Phase 2 Study of Erdafitinib in patients with Advanced Solid Tumours and FGFR Gene Alterations
This study seeks to evaluate the efficacy of erdafitinib in terms of overall response rate in participants with advanced solid tumours with FGFR (fibroblast growth factor receptor) mutations and gene fusions.
Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in those with metastatic urothelial cancer and cholangiocarcinoma who have alterations in the FGFR pathway.Read More
A phase 2 study of Futibatinib in Patients With Specific FGFR Aberrations
Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.Read More
Trials in set up
For information on trials that are currently in set up, please click here
Current trials no longer recruiting
For information on trials that are no longer recruiting, but are still live, please click here
The NIHR (National Institute for Health Research) “Be Part of Research” website has details of all UK clinical trials. Visit: bepartofresearch.nihr.ac.uk and search for the name or number of the trial you are interested in.
Cancer Research UK also lists clinical trials for bile duct cancer (cholangiocarcinoma). To see this, click here
For information on current treatments for cholangiocarcinoma, click here