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”

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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.)

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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”

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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.

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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.

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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.

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