Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

Summary

This is a single center, nonrandom, open-label study aiming to evluate the efficacy and safety of lenvatinib for patients with pretreated advanced biliary tract cancer.

Timeline

Start

2018-01-01

Primary completion

2020-12-01

Completion

2021-05-01

Publications

• Results Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
• Results Marquardt JU, Saborowski A, Czauderna C, Vogel A. The Changing Landscape of Systemic Treatment of Advanced Hepatocellular Carcinoma: New Targeted Agents and Immunotherapies. Target Oncol. 2019 Apr;14(2):115-123. doi: 10.1007/s11523-019-00624-w.
• Results Obi S, Sato T, Sato S, Kanda M, Tokudome Y, Kojima Y, Suzuki Y, Hosoda K, Kawai T, Kondo Y, Isomura Y, Ohyama H, Nakagomi K, Ashizawa H, Miura Y, Amano H, Mochizuki H, Omata M. The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting. Hepatol Int. 2019 Mar;13(2):199-204. doi: 10.1007/s12072-019-09929-4. Epub 2019 Jan 22.
• Results Hiraoka A, Kumada T, Kariyama K, Takaguchi K, Atsukawa M, Itobayashi E, Tsuji K, Tajiri K, Hirooka M, Shimada N, Shibata H, Ishikawa T, Ochi H, Tada T, Toyoda H, Nouso K, Tsutsui A, Itokawa N, Imai M, Joko K, Hiasa Y, Michitaka K; Real-life Practice Experts for HCC (RELPEC) Study Group, HCC 48 Group (hepatocellular carcinoma experts from 48 clinics in Japan). Clinical features of lenvatinib for unresectable hepatocellular carcinoma in real-world conditions: Multicenter analysis. Cancer Med. 2019 Jan;8(1):137-146. doi: 10.1002/cam4.1909. Epub 2018 Dec 21.
• Results El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.
• Results Zhang B, Zhang B, Zhang Z, Huang Z, Chen Y, Chen M, Bie P, Peng B, Wu L, Wang Z, Li B, Fan J, Qin L, Chen P, Liu J, Tang Z, Niu J, Yin X, Li D, He S, Jiang B, Mao Y, Zhou W, Chen X. 42,573 cases of hepatectomy in China: a multicenter retrospective investigation. Sci China Life Sci. 2018 Jun;61(6):660-670. doi: 10.1007/s11427-017-9259-9. Epub 2018 Feb 2.
• Results Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
• Results Witjes CD, Karim-Kos HE, Visser O, de Vries E, IJzermans JN, de Man RA, Coebergh JW, Verhoef C. Intrahepatic cholangiocarcinoma in a low endemic area: rising incidence and improved survival. HPB (Oxford). 2012 Nov;14(11):777-81. doi: 10.1111/j.1477-2574.2012.00536.x. Epub 2012 Aug 17.
• Results Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, Pawlik TM, Gores GJ. Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol. 2014 Jun;60(6):1268-89. doi: 10.1016/j.jhep.2014.01.021. Epub 2014 Mar 27. No abstract available.
• Results Ueno M, Ikeda M, Sasaki T, Nagashima F, Mizuno N, Shimizu S, Ikezawa H, Hayata N, Nakajima R, Morizane C. Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results. BMC Cancer. 2020 Nov 16;20(1):1105. doi: 10.1186/s12885-020-07365-4.
• Results Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
• Results Zhou J, Sun HC, Wang Z, Cong WM, Wang JH, Zeng MS, Yang JM, Bie P, Liu LX, Wen TF, Han GH, Wang MQ, Liu RB, Lu LG, Ren ZG, Chen MS, Zeng ZC, Liang P, Liang CH, Chen M, Yan FH, Wang WP, Ji Y, Cheng WW, Dai CL, Jia WD, Li YM, Li YX, Liang J, Liu TS, Lv GY, Mao YL, Ren WX, Shi HC, Wang WT, Wang XY, Xing BC, Xu JM, Yang JY, Yang YF, Ye SL, Yin ZY, Zhang BH, Zhang SJ, Zhou WP, Zhu JY, Liu R, Shi YH, Xiao YS, Dai Z, Teng GJ, Cai JQ, Wang WL, Dong JH, Li Q, Shen F, Qin SK, Fan J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition). Liver Cancer. 2018 Sep;7(3):235-260. doi: 10.1159/000488035. Epub 2018 Jun 14.
• Results Ji X, Bu ZD, Yan Y, Li ZY, Wu AW, Zhang LH, Zhang J, Wu XJ, Zong XL, Li SX, Shan F, Jia ZY, Ji JF. The 8th edition of the American Joint Committee on Cancer tumor-node-metastasis staging system for gastric cancer is superior to the 7th edition: results from a Chinese mono-institutional study of 1663 patients. Gastric Cancer. 2018 Jul;21(4):643-652. doi: 10.1007/s10120-017-0779-5. Epub 2017 Nov 22.
• Results Al-Salama ZT, Syed YY, Scott LJ. Lenvatinib: A Review in Hepatocellular Carcinoma. Drugs. 2019 Apr;79(6):665-674. doi: 10.1007/s40265-019-01116-x.
• Results Zhu RX, Seto WK, Lai CL, Yuen MF. Epidemiology of Hepatocellular Carcinoma in the Asia-Pacific Region. Gut Liver. 2016 May 23;10(3):332-9. doi: 10.5009/gnl15257.
• Results Ghidini M, Pizzo C, Botticelli A, Hahne JC, Passalacqua R, Tomasello G, Petrelli F. Biliary tract cancer: current challenges and future prospects. Cancer Manag Res. 2018 Dec 28;11:379-388. doi: 10.2147/CMAR.S157156. eCollection 2019.
• Results Sohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20.
• Results Snyder A, Morrissey MP, Hellmann MD. Use of Circulating Tumor DNA for Cancer Immunotherapy. Clin Cancer Res. 2019 Dec 1;25(23):6909-6915. doi: 10.1158/1078-0432.CCR-18-2688. Epub 2019 Jul 8.
• Results Wang D, Lin J, Yang X, Long J, Bai Y, Yang X, Mao Y, Sang X, Seery S, Zhao H. Combination regimens with PD-1/PD-L1 immune checkpoint inhibitors for gastrointestinal malignancies. J Hematol Oncol. 2019 Apr 24;12(1):42. doi: 10.1186/s13045-019-0730-9.
• Results Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu AX. New Horizons for Precision Medicine in Biliary Tract Cancers. Cancer Discov. 2017 Sep;7(9):943-962. doi: 10.1158/2159-8290.CD-17-0245. Epub 2017 Aug 17.
• Results Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.
• Results Matsuki M, Hoshi T, Yamamoto Y, Ikemori-Kawada M, Minoshima Y, Funahashi Y, Matsui J. Lenvatinib inhibits angiogenesis and tumor fibroblast growth factor signaling pathways in human hepatocellular carcinoma models. Cancer Med. 2018 Jun;7(6):2641-2653. doi: 10.1002/cam4.1517. Epub 2018 May 7.

Drugs

Indications