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, Targeted Therapies and Immunotherapy
No two tumours are exactly the same. The genetic characteristics of a cancer will vary from one patient to the next, which means that even patients with the same type of cancer may respond differently to the same treatment.
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, with studies being carried out to find target agents, and also genomic or molecular profiling, 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.
For more information on Molecular Profiling and Targeted Therapies
For more detailed information, plus a short animated film “Cholangiocarcinoma and the importance of molecular testing” and a booklet, “ Molecular testing in cholangiocarcinoma”, click here
For information on therapy approvals by NICE (National Institute of Health and Care Excellence (England and Wales)) and SMC (Scottish Medicines Consortium), click here
Efficacy and Safety of Zanidatamab with Standard-of-care Therapy against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
This clinical trial is to see how well a new treatment works for people with HER2 biliary tract cancer, and is being tested a first option for those who have not yet received other treatments for their cancer.
The treatment includes a drug called Zanidatamab given in combination with two chemotherapy medicines (Cisplatin and Gemcitabine). Additionally some patients may also receive an immunotherapy to help the immune system fight the cancer (this will be either Durvalumab or Pembrolizumab). Doctors want to learn if adding this immune-based medicine improves results.
This is an international trial, open across many centres including across Europe and in the UK.
FIRST-308
FIRST-308 is a global Phase III clinical trial evaluating the targeted therapy tinengotinib in patients with advanced cholangiocarcinoma who have a FGFR2 mutation and have previously received chemotherapy and targeted therapy with a FGFR inhibitor.
The study will compare the safety and efficacy of tinengotinib against the physician’s choice of FOLFOX or FOLFIRI.
The study is recruiting patients in the UK, US, EU, and Asia.
Read MoreSAFIR ABC-10
SAFIR ABC-10 is a Phase 3, international (UK, France, Belgium) multicentre, randomised, trial to evaluate whether the introduction of molecular targeted therapy as maintenance treatment after 4 cycles of standard-of-care first-line systemic therapy* is better than the continuation of standard-of-care first-line systemic therapy in the treatment of patients with Advanced Biliary Cancer (ABC; cholangiocarcinoma; bile duct cancer).
The trial is composed of two phases:
1 An initial screening phase to identify suitable patients
2 A randomised comparative trial
*Current standard-of-care first-line systemic therapy is durvalumab plus gemcitabine and cisplatin. For more information on this, see: https://ammf.org.uk/treatment-options/#chemotherapy
For a more detailed overview of the SAFIR ABC-10 trial, please click the Read More button
16.01.2025: To read UCL’s press release about the SAFIR ABC-10 trial, including a comment from AMMF’s CEO, click here.
Read MoreDETERMINE
DETERMINE is the first UK national precision medicine trial in rare cancers*, testing a range of therapies specifically targeting key genetic changes in cancer cells.
A non-randomised trial, DETERMINE will explore whether treatments approved for use in some cancer types can target identifiable genetic alterations in other types. And provide new treatments options for those who might not have any left.
This could include those with a BRAF V600 mutation-positive cholangiocarcinoma, or with HER2 amplification or activating mutations.
For further details, please see the Read More page.
* Rare is defined generally as incidence fewer than 6 cases in 100,000 patients, or common cancers with rare alterations
Read MoreARTEMIDE-Biliary01
A phase III double blind placebo-controlled study of Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer (BTC) After Resection
ARTEMIDE-Biliary01 is investigating whether giving rilvegostomig (an immunotherapy drug) together with standard chemotherapy, may delay or lower the chance of BTC coming back after surgery as compared to chemotherapy plus placebo. The study is being conducted in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) who are free of disease after surgery.
Read MoreIvosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Patients With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
This is a Phase 1/2 study evaluating the safety, tolerability, and activity of the targeted therapy ivosidenib in combination with immunotherapy in patients with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutant.
Please note: For those with CCA who have an IDH1 mutation and who have already undergone one other treatment, NICE have approved the targeted therapy ivosidenib. For more information on ivosidenib for CCA with an IDH1 mutation, and other CCA treatments, see: https://ammf.org.uk/treatment-options/
Read MoreFIGHT-302
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 MoreAsp-PSC – a study for those with primary sclerosing cholangitis (PSC)
Evaluating aspirin in reducing cancer and improving outcomes for those with primary sclerosing cholangitis.
If you are interested in finding out more about this study, please click the Read More button.
Read MoreBiliary Tract Cancer Virtual Tissue Bank – BTC VTB
Biliary tract cancers include cholangiocarcinoma (intrahepatic, perihilar, and extrahepatic), gallbladder cancer and ampullary cancer
The aim of the Biliary Tract Cancer Virtual Tissue Bank (BTC VTB) is to create a national tissue bank of human tissue samples (e.g. blood, tissue) from patients who had a biliary tract cancer and who have taken part in particular clinical trials.
The samples will be stored in two locations in Manchester and London and the management of the samples will be run by UCL Cancer Trials Centre in London.
Biliary tract cancers are quite rare with poor outcomes and it is often difficult to obtain large amounts of tissue, which makes this tissue bank extremely valuable. Our aim is to make samples available for researchers so that more research can be done in biliary tract cancers which will, hopefully, help future patients. If we are better able to understand these cancers then the correct treatments can be used in clinical trials, which will then be used in clinic if successful.
For more information: https://www.ctc.ucl.ac.uk/TrialDetails.aspx?Trial=125&
Trials in setup
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.
Further information about clinical trials
Be Part of Research
Be Part of Research is a free service provided by The National Institute for Health Research (NIHR) which aims to make it easy to find and take part in health and care research in the UK.
You can use the search function on their website or sign-up to be sent details of approved studies and clinical trials that match your interests.
European Clinical Trials
For information about clinical trials in Europe, ClinicalTrials.eu provides trusted, accessible information.
