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.

Current Cholangiocarcinoma TrialsWherever 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.


Clinical trials and COVID-19

In March 2020, at the start of the pandemic, many non-COVID-19 clinical trials were temporarily halted. On 13 July 2020, while the priority continued to be COVID-19 research, the NIHR (National Institute for Health Research) stated that the restoration of the broad range of clinical trials should begin.

Wherever possible this is happening, but will depend on local capacity and R & D approval. For more information, click here.


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.

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ACTICCA-1

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”

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ABC-07 (SBRT)

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.

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ABC-09 (EORTC-1607-GITCG)

A first line Phase II trial for inoperable, recurrent and metastatic cholangiocarcinoma (intra- and extrahepatic) and gall bladder cancer patients.

This will be a single arm study of first line Pembrolizumab and Gemcitabine/Cisplatin.

All patients on this trial will receive the immunotherapy drug Pembrolizumab in addition to the Gemcitabine/Cisplatin chemotherapy.

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Ignyta STARTRK-2

STARTRK-2 is an open-label, global, Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with locally advanced or metastatic solid tumours, and is currently recruiting in 3 centres in the UK.

Cholangiocarcinoma patients would be screened for an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene rearrangement.

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NuTide:121

NuTide:121 will compare NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients with Advanced Biliary Tract Cancer.

The study opened to recruitment in December 2019 and will enrol up to 828 patients globally. There will be a number of UK sites be participating.

(The NUC-1031 Plus Cisplatin combination was developed through the UK ABC-08 study)

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FIGHT-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.

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FIGHT-207

FIGHT-207 is a study to evaluate the efficacy and safety of pemigatinib in those with activating FGFR mutations or translocations.

Full title: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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PROOF

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”

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Erdafitinib

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.

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KEYNOTE-966

Phase 3 KEYNOTE-966 Trial: Pembrolizumab in Combination With Gemcitabine and Cisplatin for the Treatment of Advanced Biliary Tract Cancer.

This immunotherapy study is a global study of a first-line treatment for patients with advanced disease (metastatic or unresectable) and is randomised pembrolizumab (or placebo) alongside cisplatin and gemcitabine in all patients.

See: NCT04003636

This trial is currently open in St Vincent’s University Hospital, Dublin, Ireland, and Coventry in the UK and is expected to open in a number of other UK centres very soon.


ZW25 (Zanidatamab)

A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

ZW25 (Zanidatamab) is a Phase 2 single-arm, multicentre trial for people with advanced or metastatic HER2-amplified biliary tract cancers, including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer.

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TAS-120-202

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.

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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


National Institute for Health ResearchThe 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

April 2021