参考文献: 1. 中国临床肿瘤学会(CSCO)胆道恶性肿瘤诊疗指南 2022版. 2. Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17(9):557-588. doi:10.1038/s41575-020-0310-z 3. 李薇.胆道肿瘤患者的营养治疗共识[J].临床肝胆病杂志,2021,37(09):2058-2061. 4. Banales JM, Cardinale V, Carpino G, et al. Expert consensus document: Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016;13(5):261-280. doi:10.1038/nrgastro.2016.51 5. Sarcognato S, Sacchi D, Fassan M, et al. Cholangiocarcinoma. Pathologica. 2021;113(3):158-169. doi:10.32074/1591-951X-252 6. Rongshou Zheng, Siwei Zhang, Hongmei Zeng, Shaoming Wang, et al. Cancer incidence and mortality in China, 2016. Journal of the National Cancer Center. 2022;2(1): 1-9. doi:10.1016/j.jncc.2022.02.002. 7. Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273-1281. doi:10.1056/NEJMoa0908721 8. Sutherland M, Ahmed O, Zaidi A, Ahmed S. Current progress in systemic therapy for biliary tract cancers. J Hepatobiliary Pancreat Sci. 2022;29(10):1094-1107. doi:10.1002/jhbp.939 9. NCCN. Clinical practice guidelines in oncology: Hepatobiliary cancers. 2021 v5. 10. 中国临床肿瘤学会(CSCO)胆道恶性肿瘤诊疗指南 2021版. 11. D. Sakai, M. Kanai, S. Kobayashi, H. Eguchi, et al. Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). Annals of Oncology. 2018; 29(suppl_8): viii205. 12. Shroff RT, Javle MM, Xiao L, et al. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019;5(6):824-830. doi:10.1001/jamaoncol.2019.0270 13. Rachna T. Shroff, Katherine A Guthrie, Aaron James Scott, et al. SWOG 1815: A phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers. J Clin Oncol. 2023; 41:4_suppl, LBA490 14. Do-Youn Oh, Aiwu Ruth He, Shukui Qin, et al. A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1. J Clin Oncol. 2022; 40:4_suppl, 378. 15.Kelley RK, Ueno M, Yoo C, et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2023 Sep 16;402(10406):964]. Lancet. 2023;401(10391):1853-1865. doi:10.1016/S0140-6736(23)00727-4 16.NCCN. Clinical practice guidelines in oncology: Biliary Tract Cancers. 2023 v2. 17.中国临床肿瘤学会(CSCO)胆道恶性肿瘤诊疗指南 2023版. 18.Do-Youn Oh, et al. ESMO ASIA 2022. Abstract 68O. 19.Zhou Jian, Jia Fan, Guo-Ming Shi,et al. Gemox chemotherapy in combination with anti-PD1 antibody toripalimab and lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma: A phase 2 clinical trial. J Clin Oncol.2021;39:15_suppl, 4094 20. Shanghai Junshi Bioscience Co., Ltd.Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study[EB/OL].(2022-10-01). https://clinicaltrials.gov/study/NCT05342194?term=NCT05342194&rank=1 21.Anthony B. El-Khoueiry, Zhenggang Ren, Hongjae Chon, et al. IMbrave151: A phase 2, randomized, double-blind, placebo-controlled study of atezolizumab with or without bevacizumab in combination with cisplatin plus gemcitabine in patients with untreated, advanced biliary tract cancer. J Clin Oncol. 2023;41:4_suppl, 491. 22.X. Wang, S. Fu, K. Zheng, et al. A phase II trial of hepatic arterial infusion chemotherapy and bevacizumab in combination with toripalimab for advanced biliary tract cancers: Interim report. Annals of Oncology. 2022,33(Suppl_7):S568. 23.Zhou Jian, Jia Fan, Guo-Ming Shi, et al. Lenvatinib plus toripalimab as first-line treatment for advanced intrahepatic cholangiocarcinoma: A single-arm, phase 2 trial. J Clin Oncol. 2021; 39:15_suppl, 4099. 24.Lamarca A, Palmer DH, Wasan HS, et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021;22(5):690-701. doi:10.1016/S1470-2045(21)00027-9; 25. Zheng Y, Tu X, Zhao P, et al. A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin. Br J Cancer. 2018;119(3):291-295. doi:10.1038/s41416-018-0138-2 26. Changhoon Yoo, Kyu-Pyo Kim, Ilhwan Kim, et al. Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): Multicenter comparative randomized phase 2b study (NIFTY). J Clin Oncol. 2021; 39:15_suppl, 4006. 27.Luis Villanueva, Zarnie Lwin, Hyun Cheol Cheol Chung, et al. Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase 2 LEAP-005 study. J Clin Oncol. 2021; 39:15_suppl, 4080. 28.Zhou J, Sun Y, Zhang W, et al. Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. Hepatology. 2023;77(1):65-76. doi:10.1002/hep.32548 29.Arkenau HT, Martin-Liberal J, Calvo E, et al. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). Oncologist. 2018;23(12):1407-e136. doi:10.1634/theoncologist.2018-0044 30.Lin J, Yang X, Long J, et al. Pembrolizumab combined with lenvatinib as non-first-line therapy in patients with refractory biliary tract carcinoma. Hepatobiliary Surg Nutr. 2020;9(4):414-424. doi:10.21037/hbsn-20-338 31. Luis Villanueva, Zarnie Lwin, Hyun Cheol Chung, et al. Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase II LEAP-005 study. J Clin Oncol. 2021; 39:3_suppl, 321. 32.Sophie Cousin, Carine A. Bellera, Jean Philippe Guégan, et al. Regomune: A phase II study of regorafenib + avelumab in solid tumors—Results of the biliary tract cancer (BTC) cohort. J Clin Oncol. 2021; 39:15_suppl, 4096. 33.Ciardiello D, Maiorano BA, Parente P, et al. Immunotherapy for Biliary Tract Cancer in the Era of Precision Medicine: Current Knowledge and Future Perspectives. Int J Mol Sci. 2022;23(2):820. Published 2022 Jan 13. doi:10.3390/ijms23020820 34.Koeberle D, Fritsch R. Targeting HER2 in Biliary Tract Carcinomas: Challenges and Opportunities. Oncol Res Treat. 2021;44(1-2):1-3. doi:10.1159/000513847 35. Subbiah V, Lassen U, Élez E, et al. Dabrafenib plus trametinib in patients with BRAFV600E-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020;21(9):1234-1243. doi:10.1016/S1470-2045(20)30321-1 36.Yin-Hsun Feng, Wu-Chou Su, Do-Youn Oh, et al. Updated analysis with longer follow up of a phase 2a study evaluating erdafitinib in Asian patients (pts) with advanced cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) alterations. J Clin Oncol. 2022; 40:4_suppl, 430. 37. Lipika Goyal, Funda Meric-Bernstam, Antoine Hollebecque, et al. Updated results of the FOENIX-CCA2 trial: Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements. J Clin Oncol. 2022; 40:16_suppl, 4009. 38.Milind M. Javle, Do-Youn Oh, Masafumi Ikeda, et al. Results from TreeTopp: A randomized phase II study of the efficacy and safety of varlitinib plus capecitabine versus placebo in second-line (2L) advanced or metastatic biliary tract cancer (BTC). J Clin Oncol. 2020; 38:15_suppl, 4597. 39. James J. Harding, James M. Cleary, David I. Quinn, et al. Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib: Results from the phase II SUMMIT ‘basket’ trial. J Clin Oncol. 2021; 39:3_suppl, 320. 40. Javle M, Borad MJ, Azad NS, et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021;22(9):1290-1300. doi:10.1016/S1470-2045(21)00336-3 41. Choong-kun Lee, Hong Jae Chon, Jaekyung Cheon, e al. Trastuzumab plus FOLFOX for gemcitabine/cisplatin refractory HER2-positive biliary tract cancer: A multi-institutional phase II trial of the Korean Cancer Study Group (KCSG-HB19-14). J Clin Oncol. 2022; 40:16_suppl, 4096. 42.Akihiro Ohba, Chigusa Morizane, Yasuyuki Kawamoto, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing unresectable or recurrent biliary tract cancer (BTC): An investigator-initiated multicenter phase 2 study (HERB trial). J Clin Oncol. 2022; 40:16_suppl, 4006. 43. Funda Meric-Bernstam, Diana L. Hanna, Anthony B. El-Khoueiry, et al. Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study. J Clin Oncol. 2021; 39:3_suppl, 299. 44. Shubham Pant, Michel Ducreux, James J. Harding, et al. A phase IIb, open-label, single-arm study of zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers. J Clin Oncol. 2021; 39:3_suppl, TPS352. 45.Ricci AD, Rizzo A, Bonucci C, et al. PARP Inhibitors in Biliary Tract Cancer: A New Kid on the Block?. Medicines (Basel). 2020;7(9):54. Published 2020 Aug 31. doi:10.3390/medicines7090054 46. Yasuyuki Kawamoto, Chigusa Morizane, Yoshito Komatsu,et al. An investigator-initiated phase II trial of a PARP inhibitor niraparib monotherapy for patients with pre-treated, BRCA-mutated, unresectable/recurrent biliary tract, pancreatic, and other gastrointestinal cancers (NIR-B trial). J Clin Oncol. 2022; 40:16_suppl, TPS4174. |