The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer

Summary

The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.

Timeline

Start

2024-06-12

Primary completion

2027-03-30

Completion

2028-09-30

Publications

• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Background Saha SK, Zhu AX, Fuchs CS, Brooks GA. Forty-Year Trends in Cholangiocarcinoma Incidence in the U.S.: Intrahepatic Disease on the Rise. Oncologist. 2016 May;21(5):594-9. doi: 10.1634/theoncologist.2015-0446. Epub 2016 Mar 21.
• Background Ribero D, Pinna AD, Guglielmi A, Ponti A, Nuzzo G, Giulini SM, Aldrighetti L, Calise F, Gerunda GE, Tomatis M, Amisano M, Berloco P, Torzilli G, Capussotti L; Italian Intrahepatic Cholangiocarcinoma Study Group. Surgical Approach for Long-term Survival of Patients With Intrahepatic Cholangiocarcinoma: A Multi-institutional Analysis of 434 Patients. Arch Surg. 2012 Dec;147(12):1107-13. doi: 10.1001/archsurg.2012.1962.
• Background Si A, Li J, Xiang H, Zhang S, Bai S, Yang P, Zhang X, Xia Y, Wang K, Yan Z, Lau WY, Shi L, Shen F. Actual over 10-year survival after liver resection for patients with intrahepatic cholangiocarcinoma. Oncotarget. 2017 Jul 4;8(27):44521-44532. doi: 10.18632/oncotarget.17815.
• Background Tarchi P, Tabrizian P, Prigoff J, Schwartz M. Outcomes of resection for solitary </=5 cm intrahepatic cholangiocarcinoma. Surgery. 2018 Apr;163(4):698-702. doi: 10.1016/j.surg.2017.09.058. Epub 2017 Dec 23.
• Background Yeh CN, Hsieh FJ, Chiang KC, Chen JS, Yeh TS, Jan YY, Chen MF. Clinical effect of a positive surgical margin after hepatectomy on survival of patients with intrahepatic cholangiocarcinoma. Drug Des Devel Ther. 2014 Dec 17;9:163-74. doi: 10.2147/DDDT.S74940. eCollection 2015.
• Background Lang H, Sotiropoulos GC, Fruhauf NR, Domland M, Paul A, Kind EM, Malago M, Broelsch CE. Extended hepatectomy for intrahepatic cholangiocellular carcinoma (ICC): when is it worthwhile? Single center experience with 27 resections in 50 patients over a 5-year period. Ann Surg. 2005 Jan;241(1):134-43. doi: 10.1097/01.sla.0000149426.08580.a1.
• Background Mazzaferro V, Gorgen A, Roayaie S, Droz Dit Busset M, Sapisochin G. Liver resection and transplantation for intrahepatic cholangiocarcinoma. J Hepatol. 2020 Feb;72(2):364-377. doi: 10.1016/j.jhep.2019.11.020.
• Background De Martin E, Rayar M, Golse N, Dupeux M, Gelli M, Gnemmi V, Allard MA, Cherqui D, Sa Cunha A, Adam R, Coilly A, Antonini TM, Guettier C, Samuel D, Boudjema K, Boleslawski E, Vibert E. Analysis of Liver Resection Versus Liver Transplantation on Outcome of Small Intrahepatic Cholangiocarcinoma and Combined Hepatocellular-Cholangiocarcinoma in the Setting of Cirrhosis. Liver Transpl. 2020 Jun;26(6):785-798. doi: 10.1002/lt.25737.
• Results Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma - evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.
• Results Akateh C, Ejaz AM, Pawlik TM, Cloyd JM. Neoadjuvant treatment strategies for intrahepatic cholangiocarcinoma. World J Hepatol. 2020 Oct 27;12(10):693-708. doi: 10.4254/wjh.v12.i10.693.
• Results Labib PL, Davidson BR, Sharma RA, Pereira SP. Locoregional therapies in cholangiocarcinoma. Hepat Oncol. 2017 Oct;4(4):99-109. doi: 10.2217/hep-2017-0014. Epub 2017 Nov 17.
• Results Hyder O, Marsh JW, Salem R, Petre EN, Kalva S, Liapi E, Cosgrove D, Neal D, Kamel I, Zhu AX, Sofocleous CT, Geschwind JF, Pawlik TM. Intra-arterial therapy for advanced intrahepatic cholangiocarcinoma: a multi-institutional analysis. Ann Surg Oncol. 2013 Nov;20(12):3779-86. doi: 10.1245/s10434-013-3127-y. Epub 2013 Jul 12.
• Results Kuhlmann JB, Euringer W, Spangenberg HC, Breidert M, Blum HE, Harder J, Fischer R. Treatment of unresectable cholangiocarcinoma: conventional transarterial chemoembolization compared with drug eluting bead-transarterial chemoembolization and systemic chemotherapy. Eur J Gastroenterol Hepatol. 2012 Apr;24(4):437-43. doi: 10.1097/MEG.0b013e3283502241.
• Results Sommer CM, Kauczor HU, Pereira PL. Locoregional Therapies of Cholangiocarcinoma. Visc Med. 2016 Dec;32(6):414-420. doi: 10.1159/000453010. Epub 2016 Dec 5.
• Results Han K, Ko HK, Kim KW, Won HJ, Shin YM, Kim PN. Radiofrequency ablation in the treatment of unresectable intrahepatic cholangiocarcinoma: systematic review and meta-analysis. J Vasc Interv Radiol. 2015 Jul;26(7):943-8. doi: 10.1016/j.jvir.2015.02.024. Epub 2015 Apr 18.
• Results Pillai K, Akhter J, Chua TC, Shehata M, Alzahrani N, Al-Alem I, Morris DL. Heat sink effect on tumor ablation characteristics as observed in monopolar radiofrequency, bipolar radiofrequency, and microwave, using ex vivo calf liver model. Medicine (Baltimore). 2015 Mar;94(9):e580. doi: 10.1097/MD.0000000000000580.
• Results Yang L, Shan J, Shan L, Saxena A, Bester L, Morris DL. Trans-arterial embolisation therapies for unresectable intrahepatic cholangiocarcinoma: a systematic review. J Gastrointest Oncol. 2015 Oct;6(5):570-88. doi: 10.3978/j.issn.2078-6891.2015.055.
• Results Zhen Y, Liu B, Chang Z, Ren H, Liu Z, Zheng J. A pooled analysis of transarterial radioembolization with yttrium-90 microspheres for the treatment of unresectable intrahepatic cholangiocarcinoma. Onco Targets Ther. 2019 Jun 7;12:4489-4498. doi: 10.2147/OTT.S202875. eCollection 2019.
• Results White J, Carolan-Rees G, Dale M, Patrick HE, See TC, Bell JK, Manas DM, Crellin A, Slevin NJ, Sharma RA. Yttrium-90 Transarterial Radioembolization for Chemotherapy-Refractory Intrahepatic Cholangiocarcinoma: A Prospective, Observational Study. J Vasc Interv Radiol. 2019 Aug;30(8):1185-1192. doi: 10.1016/j.jvir.2019.03.018. Epub 2019 Jun 27.
• Results Weigt J, Malfertheiner P. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. Expert Rev Gastroenterol Hepatol. 2010 Aug;4(4):395-7. doi: 10.1586/egh.10.45.
• Results Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.
• Results Edeline J, Touchefeu Y, Guiu B, Farge O, Tougeron D, Baumgaertner I, Ayav A, Campillo-Gimenez B, Beuzit L, Pracht M, Lievre A, Le Sourd S, Boudjema K, Rolland Y, Boucher E, Garin E. Radioembolization Plus Chemotherapy for First-line Treatment of Locally Advanced Intrahepatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):51-59. doi: 10.1001/jamaoncol.2019.3702.
• Results Cheng B, Villalobos A, Sethi I, Wagstaff W, Galt J, Brandon D, Schuster DM, Bercu Z, Majdalany B, Kokabi N. Determination of Tumor Dose Response Thresholds in Patients with Chemorefractory Intrahepatic Cholangiocarcinoma Treated with Resin and Glass-based Y90 Radioembolization. Cardiovasc Intervent Radiol. 2021 Aug;44(8):1194-1203. doi: 10.1007/s00270-021-02834-0. Epub 2021 Apr 22.
• Results Camacho JC, Kokabi N, Xing M, Prajapati HJ, El-Rayes B, Kim HS. Modified response evaluation criteria in solid tumors and European Association for The Study of the Liver criteria using delayed-phase imaging at an early time point predict survival in patients with unresectable intrahepatic cholangiocarcinoma following yttrium-90 radioembolization. J Vasc Interv Radiol. 2014 Feb;25(2):256-65. doi: 10.1016/j.jvir.2013.10.056.

Drugs

Indications