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.

Flask & MicroscopeWherever 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.


 

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 randomized 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 (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 randomized 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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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.

Read More

 

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)

Read More

 

TOPAZ-1
TOPAZ-1: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.

This is a global study looking at the role of immunotherapy in addition to standard-of-care chemotherapy. All patients will receive chemotherapy (CisGem) and either durvalumab or placebo;

It will be a double-blind study – neither the patient or the treating clinician will know if the patient is receiving durvalumab or not.

This study is open and recruiting at the following UK locations:
Bristol, Cambridge, Royal Free, Hammersmith, The Christie, Queen’s Hospital (Romford) and Sheffield.


 

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.

This study is open and recruiting at the following UK locations:
Aberdeen, Addenbrookes, Royal Marsden, Imperial College, Maidstone and The Christie.


 

PROOF
PROOF: Infigratinib versus gemcitabine plus cisplatin multicenter, open-label, randomized, phase 3 study in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations.

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.


 

Current trials no longer recruiting

PCI and Chemotherapy
Update April 2019:
This small trial, using PCI (photochemical internalisation) with Gemcitabine in addition to ‘standard of care’ with 8 cycles of Gemcitabine and Cisplatin, for those patients with advanced, inoperable cholangiocarcinoma (stented), closed to recruitment on 24 April, 2019.  Results are awaited.

“Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of PCI of Gemcitabine Followed by Gemcitabine/Cisplatin Chemotherapy in Patients With Advanced Inoperable Cholangiocarcinomas”

Read More

 

SIRCCA
Update October 2019:
The SIRCCA trial, a 1st line randomised trial for those with inoperable intrahepatic cholangiocarcinoma, looking at the standard treatment of Gemcitabine and Cisplatin chemotherapy, vs SIRT (selective internal radiation therapy)* preceding the Gemcitabine and Cisplatin chemotherapy, has now closed to recruitment.  Results are expected early 2021.

* SIRT (selective internal radiation therapy) can be used to treat bile duct cancers in the liver. Millions of tiny beads, or microspheres, are fed into the hepatic artery, the main blood vessel which supplies the liver. These beads block the supply of blood to the cancer and, as they contain a radioactive substance called yttrrium-90, they also work by sending out radiation which helps to kill off the cancer cells. (This treatment is also known as radioembolisation.)

Read More

 

TAS120-101
Update November 2019:
This international Phase I/II trial for those patients who have FGF/FGFR gene abnormalities in their tumour, and for whom there are no other available therapies, closed to recruitment on 30 November 2019.  Data is currently maturing and results are awaited.

“A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities”

Read More

 

ABC-06  (2nd line chemotherapy trial)
Update June 2019: The ABC-06 study, a randomized trial for those with advanced or metastatic cholangiocarcinoma who have already received first line treatment with the combination Gemcitabine/Cisplatin chemotherapy, met its recruitment target of 162 patients on 5th January, 2018.

The initial results of the trial were presented at the prestigious international ASCO conference in Chicago in early June 2019, and the treatment given under the ABC-06 trial, mFOLFOX, now looks set to become the new global 2nd line standard of care.

For more information on the ABC-06 study and the important outcome, click the Read More button.

Read More

 

Agios ClarIDHy
Update May 2019: Agios has announced that the randomized Phase 3 ClarIDHy trial of TIBSOVO® (ivosidenib) achieved its primary endpoint in previously treated IDH1 mutant cholangiocarcinoma patients.

Treatment with TIBSOVO® demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. The safety profile observed in the study was consistent with previously published data.

Further details can be found in the press release from Agios, available here.

ABC-08
Update: The ABC-08 trial has met its recruitment target and is no longer recruiting new patients. More information on a new Acelarin Biliary study will be available shortly.
(Acelarin developed by NuCana)

ABC-08 is a single arm trial for those with inoperable or recurrent/metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma.  All patients will receive Cisplatin chemotherapy and Acelarin.

The results of the ABC-02 trial established the Gemcitabine and Cisplatin combination of chemotherapy as the first line treatment standard of care for inoperable cholangiocarcinoma patients.  In this trial, Acelarin, a drug designed to specifically overcome the key cancer resistance mechanisms associated with Gemcitabine, will be used in combination with Cisplatin.

Read More

 

Incyte INCB054828
Update August 2018:
The Incyte INCB054828 trial is no longer recruiting new patients.

This is a Phase 2, open-label, single-arm, multicentre international study to evaluate the efficacy and safety of the drug INCB054828 in patients with Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma, including FGFR2 translocations, who failed previous therapy.

Read More


Trials in set up
For information on trials that are currently in set up, 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

February 2020