Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies

Summary

This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.

Timeline

Start

2026-05-30

Primary completion

2028-03-30

Completion

2030-03-30

Publications

• Background Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021 Jan 30;397(10272):428-444. doi: 10.1016/S0140-6736(21)00153-7.
• Background Zhao Z, Wu H, Han J, Jiang K. Global trends and disparities in gallbladder and biliary tract cancers: insights from the global burden of disease study 2021. Eur J Gastroenterol Hepatol. 2025 May 1;37(5):573-584. doi: 10.1097/MEG.0000000000002947. Epub 2025 Feb 14.
• Background Wang Y, Xun Z, Yang X, Wang Y, Wang S, Xue J, Zhang N, Yang X, Lu Z, Zhou J, Zhou K, Sang X, Zhao H. Local-regional therapy combined with toripalimab and lenvatinib in patients with advanced biliary tract cancer. Am J Cancer Res. 2023 Mar 15;13(3):1026-1037. eCollection 2023.
• Background von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.
• Background Le Roy B, Gelli M, Pittau G, Allard MA, Pereira B, Serji B, Vibert E, Castaing D, Adam R, Cherqui D, Sa Cunha A. Neoadjuvant chemotherapy for initially unresectable intrahepatic cholangiocarcinoma. Br J Surg. 2018 Jun;105(7):839-847. doi: 10.1002/bjs.10641. Epub 2017 Aug 31.
• Background Oh DY, Ruth He A, Qin S, Chen LT, Okusaka T, Vogel A, Kim JW, Suksombooncharoen T, Ah Lee M, Kitano M, Burris H, Bouattour M, Tanasanvimon S, McNamara MG, Zaucha R, Avallone A, Tan B, Cundom J, Lee CK, Takahashi H, Ikeda M, Chen JS, Wang J, Makowsky M, Rokutanda N, He P, Kurland JF, Cohen G, Valle JW. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.
• Background Pereira RA, Barcellos G, Lenz G, Pereira AAL, Biachi de Castria T. Neoadjuvant Chemotherapy in Resectable Biliary Tract Cancer: A Systematic Review and Metanalysis. J Surg Oncol. 2026 Mar;133(3):313-325. doi: 10.1002/jso.70169. Epub 2025 Dec 22.
• Background Chen F, Sheng J, Li X, Gao Z, Hu L, Chen M, Fei J, Song Z. Tumor-associated macrophages: orchestrators of cholangiocarcinoma progression. Front Immunol. 2024 Sep 3;15:1451474. doi: 10.3389/fimmu.2024.1451474. eCollection 2024.
• Background Chen C, Chen Z, Chen D, Zhang B, Wang Z, Le H. Suppressive effects of gemcitabine plus cisplatin chemotherapy on regulatory T cells in nonsmall-cell lung cancer. J Int Med Res. 2015 Apr;43(2):180-7. doi: 10.1177/0300060514561504. Epub 2015 Feb 6.
• Background Xue Y, Gao S, Gou J, Yin T, He H, Wang Y, Zhang Y, Tang X, Wu R. Platinum-based chemotherapy in combination with PD-1/PD-L1 inhibitors: preclinical and clinical studies and mechanism of action. Expert Opin Drug Deliv. 2021 Feb;18(2):187-203. doi: 10.1080/17425247.2021.1825376. Epub 2020 Oct 5.
• Background Chen Y, Zhang J, Hu W, Li X, Sun K, Shen Y, Zhang M, Wu J, Gao S, Yu J, Que R, Zhang Y, Yang F, Xia W, Zhang A, Tang X, Bai X, Liang T. Envafolimab plus lenvatinib and transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2024 Oct 9;9(1):280. doi: 10.1038/s41392-024-01991-1.
• Background Shi GM, Huang XY, Liang F, Liang X, Dong R, Ye QH, Gao Q, Ji Y, Yu ZP, Zhai WL, Lu JC, Li XW, Liu FB, Wang K, Yang W, Zhang JL, Hu ZQ, Qiu SJ, Wang XY, Yang XR, Sun HC, Shi YH, Ding ZB, Liu WR, Huang XW, Huang C, Shen YH, Sun J, He YF, Peng YF, Xu Y, Zou JJ, Zhou J, Fan J; ZSAB Study Group. Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma. N Engl J Med. 2026 Mar 5;394(10):983-995. doi: 10.1056/NEJMoa2513918.

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Indications