PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Summary

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

Timeline

Start

2023-01-31

Primary completion

2027-01-31

Completion

2027-12-31

Publications

• Background DeOliveira ML, Cunningham SC, Cameron JL, Kamangar F, Winter JM, Lillemoe KD, Choti MA, Yeo CJ, Schulick RD. Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution. Ann Surg. 2007 May;245(5):755-62. doi: 10.1097/01.sla.0000251366.62632.d3.
• Background Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.
• Background Groot Koerkamp B, Wiggers JK, Allen PJ, Besselink MG, Blumgart LH, Busch OR, Coelen RJ, D'Angelica MI, DeMatteo RP, Gouma DJ, Kingham TP, Jarnagin WR, van Gulik TM. Recurrence Rate and Pattern of Perihilar Cholangiocarcinoma after Curative Intent Resection. J Am Coll Surg. 2015 Dec;221(6):1041-9. doi: 10.1016/j.jamcollsurg.2015.09.005. Epub 2015 Sep 15.
• Background Abdel-Rahman O, Elsayed Z, Elhalawani H. Gemcitabine-based chemotherapy for advanced biliary tract carcinomas. Cochrane Database Syst Rev. 2018 Apr 6;4(4):CD011746. doi: 10.1002/14651858.CD011746.pub2.
• Background Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. doi: 10.1002/bjs.10776.
• Background Nassour I, Mokdad AA, Porembka MR, Choti MA, Polanco PM, Mansour JC, Minter RM, Wang SC, Yopp AC. Adjuvant Therapy Is Associated With Improved Survival in Resected Perihilar Cholangiocarcinoma: A Propensity Matched Study. Ann Surg Oncol. 2018 May;25(5):1193-1201. doi: 10.1245/s10434-018-6388-7. Epub 2018 Feb 27.
• Background Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assenat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardiere C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. doi: 10.1200/JCO.18.00050. Epub 2019 Feb 1.
• Background Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. doi: 10.1016/S1470-2045(18)30915-X. Epub 2019 Mar 25.
• Background Ueno M, Ikeda M, Morizane C, Kobayashi S, Ohno I, Kondo S, Okano N, Kimura K, Asada S, Namba Y, Okusaka T, Furuse J. Nivolumab alone or in combination with cisplatin plus gemcitabine in Japanese patients with unresectable or recurrent biliary tract cancer: a non-randomised, multicentre, open-label, phase 1 study. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):611-621. doi: 10.1016/S2468-1253(19)30086-X. Epub 2019 May 17.
• Background Banales JM, Marin JJG, Lamarca A, Rodrigues PM, Khan SA, Roberts LR, Cardinale V, Carpino G, Andersen JB, Braconi C, Calvisi DF, Perugorria MJ, Fabris L, Boulter L, Macias RIR, Gaudio E, Alvaro D, Gradilone SA, Strazzabosco M, Marzioni M, Coulouarn C, Fouassier L, Raggi C, Invernizzi P, Mertens JC, Moncsek A, Ilyas SI, Heimbach J, Koerkamp BG, Bruix J, Forner A, Bridgewater J, Valle JW, Gores GJ. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):557-588. doi: 10.1038/s41575-020-0310-z. Epub 2020 Jun 30.
• Background Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.
• Background Itano O, Takemura Y, Kishida N, Tamagawa E, Shinozaki H, Ikeda K, Urakami H, Ei S, Hayatsu S, Suzuki K, Sakuragawa T, Ishii M, Shito M, Aiura K, Fujisaki H, Takano K, Matsui J, Minagawa T, Shinoda M, Kitago M, Abe Y, Yagi H, Oshima G, Hori S, Kitagawa Y. A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01). BMC Cancer. 2020 Jul 23;20(1):688. doi: 10.1186/s12885-020-07185-6.
• Background Nakahashi K, Ebata T, Yokoyama Y, Igami T, Mizuno T, Yamaguchi J, Onoe S, Watanabe N, Nagino M. How long should follow-up be continued after R0 resection of perihilar cholangiocarcinoma? Surgery. 2020 Oct;168(4):617-624. doi: 10.1016/j.surg.2020.04.068. Epub 2020 Jul 19.
• Background Gao H, Tian T, Li S, Zhang Y, Fu X, Zheng X, Liu N, Jiang A, Ren M, Zhang X, Liang X, Ruan Z, Geng Z, Yao Y. Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study. Cancer Manag Res. 2021 Jan 29;13:889-898. doi: 10.2147/CMAR.S290083. eCollection 2021.

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Indications