Current trials no longer recruiting
Update September 2021: This trial is active but no longer recruiting patients.
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.
For more details on the trial, see: NCT04003636
INTR@PID BTC 055
Update August 2021: The Phase II INTR@PID BTC 055 study from Merck has been discontinued.
Gemcitabine Plus Cisplatin with or without Bintrafusp Alfa (M7824) in Participants with 1L Biliary Tract Cancer (BTC)
Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Merck has decided to discontinue the Phase II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).
To read more, go to: https://www.merckgroup.com/en/news/bintrafusp-alfa-update-23-08-2021.html
For more details on the trial see: NCT04066491
Update January 2022: A press release from AstraZeneca now confirms the outcome of the Phase III trial, TOPAZ-1, that the immunotherapy durvalumab (Imfinzi) in combination with the standard of care 1st line treatment chemotherapies gemcitabine and cisplatin, shows “a statistically significant and clinically meaningful improvement in overall survival and progression-free survival” compared with gemcitabine and cisplatin alone. To read this press release, go to: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-plus-chemotherapy-reduced-risk-of-death-by-20-in-1st-line-advanced-biliary-tract-cancer.html
Update October 2021: “Imfinzi (durvalumab) plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase III trial at interim analysis”. To read AstraZeneca’s press release 15.10.2021, go to: https://www.astrazeneca.com/media-centre/press-releases/2021/imfinzi-improved-survival-in-biliary-tract-cancer.html
OPAZ-1: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.
For more details on TOPAZ-1, go to: https://www.clinicaltrials.gov/ct2/show/NCT03875235
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
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
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
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.
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
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
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