Current Cholangiocarcinoma Trials

Listed here are the clinical trials for those with cholangiocarcinoma 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.

Details are current as at July 2017.

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
This is a randomized trial for those who have had a resection for their cholangiocarcinoma or gall bladder cancer:

“Adjuvant Chemotherapy With Gemcitabine and Cisplatin compared to Observation after Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma”

ACTICCA-1 is a Phase III trial designed to assess the clinical performance of Gemcitabine with Cisplatin and observation vs. observation alone in patients who have undergone curative intent resection of cholangiocarcinoma or gall bladder carcinoma.

18.05.17  In the light of the BILCAP study result, this trial is no longer recruiting.  If you are currently in the trial, please contact your consultant for advice on your choices.

For more information on the BILCAP result, please go to:  http://ammf.org.uk/2017/05/18/bilcap-results-show-chemo-improves-survival

Read More

 

ABC-06  (2nd line chemotherapy trial)
ABC-06 is a randomized trial for those with advanced or metastatic cholangiocarcinoma who have already had the Gemcitabine/Cisplatin combination of chemotherapy.

“ABC-06 – 2nd line treatment trial for patients with locally advanced/metastatic biliary tract cancers previously treated with cisplatin/gemcitabine chemotherapy.

Randomised:  Active Symptom Control with OxMdG chemo (Oxaliplatin, L-folinic acid & 5FU) – against – Active Symptom Control”.

Please Note:  Patients taking part in either arm of the 2nd line ABC-06 trial may also participate in relevant Phase I trials, if eligible. (For those patients in the chemotherapy arm, at least 28 days after their last chemotherapy treatment should be allowed.) This should be done in consultation with the ABC-06 trial office.

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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 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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ABC-08
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 Acelerin.

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, Acelerin, a drug designed to specifically overcome the key cancer resistance mechanisms associated with Gemcitabine, will be used in combination with Cisplatin.

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PCI and Chemotherapy
This trial is not currently recruiting, but will re-open later in 2017.

There is a small randomised trial running in one UK centre only, Liverpool, which uses PCI (photochemical internalisation) with Gemcitabine, vs Gemcitabine and Cisplatin, and is for those patients with locally advanced, inoperable cholangiocarcinoma (stented).

“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 Locally Advanced Inoperable Cholangiocarcinomas”

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The SIRCCA Trial
SIRCCA is 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.

This international trial is due to open at several UK centres in late 2017.

* 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.)

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The TAS-120 trial
There is small Phase I/II trial running at one centre in London, for those patients who have FGFR gene abnormalities in their tumour, and for whom there are no other available therapies.

“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”

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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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Agios ClarIDHy
The ClarIDHy clinical trial is testing the safety and efficacy of an investigational medication, AG-120, in eligible patients with IDH1-mutated advanced cholangiocarcinoma.

AG-120: Investigational medication for IDH1-mutated advanced cholangiocarcinoma

This trial is due to open at several centres across the UK in late summer 2017.

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Incyte INCB054828
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.

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


 

UK Clinical Trials Gateway.The UK Clinical Trials Gateway has details on all UK clinical trials, and can help you make an informed choice about taking part in one. There is useful guidance on how trials work, and information to help connect you to researchers running trials you might be interested in.  Visit: www.ukctg.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

August 2017

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