Current status of conversion therapy for gallbladder cancer_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

SHAN Jijun , WANG Tianlin ,  LI Xiangcheng

Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, P. R. China;

Corresponding author：

LI Xiangcheng, Email: drxcli@njmu.edu.cn

Keywords：

gallbladder cancer; conversion therapy; radical resection

DOI：

10.7507/1007-9424.202303020

Video：

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We reviewed the clinical studies on drug therapy for gallbladder cancer and expounded on the current situation of conversion therapy for gallbladder cancer. Gallbladder cancer was usually diagnosed late, with high malignancy, low surgical resection rate, and poor prognosis. With the development of conversion therapy, systemic therapy combined with radical resection had effectively improved the surgical resection rate and prognosis of gallbladder cancer patients. At present, most of the published conversion therapies for gallbladder cancer were mainly retrospective researches, lacking large multicenter prospective research, and the treatment plan was still based on chemotherapy, lacking the research of targeted therapy in combination with immunotherapy. It is expected that more high-quality clinical trials can be made first-line recommendations for the conversion therapy of gallbladder cancer.

Citation： SHAN Jijun, WANG Tianlin, LI Xiangcheng. Current status of conversion therapy for gallbladder cancer. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2023, 30(4): 385-391. doi: 10.7507/1007-9424.202303020 Copy

1.	Benavides M, Antón A, Gallego J, et al. Biliary tract cancers: SEOM clinical guidelines. Clin Transl Oncol, 2015, 17(12): 982-987.
2.	Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
3.	Lamarca A, Edeline J, McNamara MG, et al. Current standards and future perspectives in adjuvant treatment for biliary tract cancers. Cancer Treat Rev, 2020, 84: 101936. doi: 10.1016/j.ctrv.2019.101936.
4.	Zhu AX, Hong TS, Hezel AF, et al. Current management of gallbladder carcinoma. Oncologist, 2010, 15(2): 168-181.
5.	Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver, 2012, 6(2): 172-187.
6.	Adam R, Aloia T, Lévi F, et al. Hepatic resection after rescue cetuximab treatment for colorectal liver metastases previously refractory to conventional systemic therapy. J Clin Oncol, 2007, 25(29): 4593-4602.
7.	Kinoshita J, Yamaguchi T, Moriyama H, et al. Current status of conversion surgery for stage Ⅳ gastric cancer. Surg Today, 2021, 51(11): 1736-1754.
8.	Tomasello G, Petrelli F, Ghidini M, et al. FOLFOXIRI plus bevacizumab as conversion therapy for patients with initially unresectable metastatic colorectal cancer: a systematic review and pooled analysis. JAMA Oncol, 2017, 3(7): e170278. doi: 10.1001/jamaoncol.2017.0278.
9.	Arita J, Ichida A, Nagata R, et al. Conversion surgery after preoperative therapy for advanced hepatocellular carcinoma in the era of molecular targeted therapy and immune checkpoint inhibitors. J Hepatobiliary Pancreat Sci, 2022, 29(7): 732-740.
10.	Yoshitomi H, Takano S, Furukawa K, et al. Conversion surgery for initially unresectable pancreatic cancer: current status and unresolved issues. Surg Today, 2019, 49(11): 894-906.
11.	汤朝晖, 陈家璐, 刘深洋, 等. 靶免联合治疗在胆道恶性肿瘤转化中应用的意义. 中华外科杂志, 2022, 60(4): 343-350.
12.	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.
13.	Morizane C, Okusaka T, Mizusawa J, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase Ⅲ clinical trial. Ann Oncol, 2019, 30(12): 1950-1958.
14.	Sharma A, Kalyan Mohanti B, Pal Chaudhary S, et al. Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: results of a phase Ⅲ randomised controlled trial. Eur J Cancer, 2019, 123: 162-170.
15.	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.
16.	Ioka T, Kanai M, Kobayashi S, et al. Randomized phase Ⅲ study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401-MITSUBA). J Hepatobiliary Pancreat Sci, 2023, 30(1): 102-110.
17.	Miura Y, Ashida R, Sugiura T, et al. Pathological complete response achieved by gemcitabine plus cisplatin therapy for initially unresectable advanced gallbladder cancer: a case report. Surg Case Rep, 2022, 8(1): 20. doi: 10.1186/s40792-022-01375-z.
18.	Inoue M, Hakoda K, Sawada H, et al. Locally advanced gallbladder cancer treated with effective chemotherapy and subsequent curative resection: a case report. J Med Case Rep, 2022, 16(1): 30. doi: 110.1186/s13256-021-03248-9.
19.	Tsuyuki H, Maruo H, Shimizu Y, et al. A case of advanced gallbladder cancer with paraaortic lymph node metastases successfully treated by chemotherapy and conversion surgery. Gan To Kagaku Ryoho, 2018, 45: 2117-2119.
20.	Wakasa Y, Toyoki Y, Kusumi T, et al. Conversion surgery following gemcitabine plus cisplatin therapy for initially unresectable gallbladder cancer with peritoneal carcinomatosis: a case report. Surg Case Rep, 2022, 8(1): 50. doi: 10.1186/s40792-022-01406-9.
21.	Creasy JM, Goldman DA, Dudeja V, et al. Systemic chemotherapy combined with resection for locally advanced gallbladder carcinoma: surgical and survival outcomes. J Am Coll Surg, 2017, 224(5): 906-916.
22.	Noji T, Nagayama M, Imai K, et al. Conversion surgery for initially unresectable biliary malignancies: a multicenter retrospective cohort study. Surg Today, 2020, 50(11): 1409-1417.
23.	Shroff RT, Guthrie KA, Scott AJ, 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: LBA490. doi: 10.1200/JCO.2023.41.6_suppl.490.
24.	Yang Z, Wu Z, Xiong Y, et al. Successful conversion surgery for locally advanced gallbladder cancer after gemcitabine and nab-paclitaxel chemotherapy. Front Oncol, 2022, 12: 977963. doi: 10.3389/fonc.2022.977963.
25.	Nara S, Ioka T, Ogawa G, et al. Randomized multicenter phase Ⅲ trial of neoadjuvant gemcitabine + cisplatin + S-1 (GCS) versus surgery first for resectable biliary tract cancer (JCOG1920: NABICAT). J Clin Oncol, 2023, 41(4_suppl): TPS621. doi: 10.1200/JCO.2023.41.4_suppl.TPS621.
26.	Valle JW, Kelley RK, Nervi B, et al. Biliary tract cancer. Lancet, 2021, 397(10272): 428-444.
27.	Duranti S, Fabi A, Filetti M, et al. Breast cancer drug approvals issued by EMA: a review of clinical trials. Cancers (Basel), 2021, 13(20): 5198. doi: 10.3390/cancers13205198.
28.	Shitara K, Baba E, Fujitani K, et al. Discovery and development of trastuzumab deruxtecan and safety management for patients with HER2-positive gastric cancer. Gastric Cancer, 2021, 24(4): 780-789.
29.	Meric-Bernstam F, Beeram M, Hamilton E, et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. Lancet Oncol, 2022, 23(12): 1558-1570.
30.	Ohba A, Morizane C, Ueno M, et al. Multicenter phase Ⅱ trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial. Future Oncol, 2022, 18(19): 2351-2360.
31.	Meric-Bernstam F, Hainsworth J, Bose R, et al. MyPathway HER2 basket study: pertuzumab (P) + trastuzumab (H) treatment of a large, tissue-agnostic cohort of patients with HER2-positive advanced solid tumors. J ClinOncol, 2021, 39(15_suppl): 3004. doi: 10.1200/JCO.2021.39.15_suppl.3004.
32.	Cannon TL, Rothe M, Garrett-Mayer E, et al. Pertuzumab plus trastuzumab (P+T) in patients (pts) with biliary tract cancer (BTC) with ERBB2/3 amplification (amp), overexpression (oe), or mutation (mut): results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study. J Clin Oncol, 2023, 41(4_suppl): 546. doi: 10.1200/JCO.2023.41.4_suppl.546.
33.	Oh DY, Park JO, Kim JW, et al. CTX-009 (ABL001), a bispecific antibody targeting DLL4 and VEGF A, in combination with paclitaxel in patients with advanced biliary tract cancer (BTC): a phase 2 study. J Clin Oncol, 2023, 41(4_suppl): 540. doi: 10.1200/JCO.2023.41.4_suppl.540.
34.	Lamarca A, Barriuso J, McNamara MG, et al. Molecular targeted therapies: ready for “prime time” in biliary tract cancer. J Hepatol, 2020, 73(1): 170-185.
35.	Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science, 2017, 357(6349): 409-413.
36.	Chen XF, Wu XF, Wu H, et al. 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, 8(2): e001240. doi: 10.1136/jitc-2020-001240.
37.	Oh DY, He AR, Qin S, 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. doi: 10.1200/JCO.2022.40.4_suppl.378.
38.	Li W, Wang Y, Yu Y, et al. Toripalimab combined with gemcitabine and S-1 in the first-line treatment of advanced biliary tract cancer. J Clin Oncol, 2022, 40(16_suppl): 4081. doi: 10.1200/JCO.2022.40.16_suppl.4081.
39.	Li X, Zhou N, Yang Y, et al. Nab-paclitaxel plus anti–PD-1 antibody as second-line treatment for advanced biliary tract cancer: an investigator-initiated phase 2 study (NapaSinti trial). J Clin Oncol, 2023, 41(4_suppl): 564. doi: 10.1200/JCO.2023.41.4_suppl.564.
40.	Jin S, Zhao R, Zhou C, et al. Updated results from the phase Ⅱ study: efficacy and safety of anlotinib plus sintilimab as second-line treatment for patients with advanced biliary tract cancers. J Clin Oncol, 2023, 41(4_suppl): 577. doi: 10.1200/JCO.2023.41.4_suppl.577.
41.	Chen X, Guo F, Zhang X, et al. A single-arm, open-label, phase Ⅱ study investigating anti-HER2 ADC plus anti-PD-1 antibody in patients with unresectable locally advanced or metastatic BTC with HER2 overexpression. J Clin Oncol, 2023, 41(4_suppl): TPS619. doi: 10.1200/JCO.2023.41.4_suppl.TPS619.
42.	Furukawa M, Ueno M, Sakai D, et al. A multicenter, single-arm, phase Ⅱ study of nivolumab in patients with biliary tract cancer with a PD-L1 combined positive score ≥1. J Clin Oncol, 2023, 41(4_suppl): 533. doi: 10.1200/JCO.2023.41.4_suppl.533.
43.	Jeong SY, Kim ST, Jang JY. The efficacy of immune checkpoint inhibitors in biliary tract cancer with KRAS mutation. J Clin Oncol, 2023, 41(4_suppl): 598. doi: 10.1200/JCO.2023.41.4_suppl.598.
44.	中华医学会外科学分会胆道外科学组, 中国医师协会外科医师分会胆道外科专业委员会. 胆囊癌诊断和治疗指南(2019版). 中华外科杂志, 2020, 58(4): 243-251.
45.	Sharma A, Pramanik R, Kumar A, et al. Safety and efficacy of modified FOLFIRINOX in unresectable or metastatic gallbladder cancer: a phase Ⅱ pilot study. JCO Glob Oncol, 2021, 7: 820-826.
46.	Gupta P, Meghashyam K, Marodia Y, et al. Locally advanced gallbladder cancer: a review of the criteria and role of imaging. Abdom Radiol (NY), 2021, 46(3): 998-1007.
47.	Kim SJ, Lee JM, Lee JY, et al. Accuracy of preoperative T-staging of gallbladder carcinoma using MDCT. AJR Am J Roentgenol, 2008, 190(1): 74-80.
48.	Tseng JH, Wan YL, Hung CF, et al. Diagnosis and staging of gallbladder carcinoma. Evaluation with dynamic MR imaging. Clin Imaging, 2002, 26(3): 177-182.
49.	Lee SW, Kim HJ, Park JH, et al. Clinical usefulness of ¹⁸F-FDG PET-CT for patients with gallbladder cancer and cholangiocarcinoma. J Gastroenterol, 2010, 45(5): 560-566.
50.	Sachan A, Saluja SS, Nekarakanti PK, et al. Raised CA19-9 and CEA have prognostic relevance in gallbladder carcinoma. BMC Cancer, 2020, 20(1): 826. doi: 10.1186/s12885-020-07334-x.
51.	Kato A, Shimizu H, Ohtsuka M, et al. Surgical resection after downsizing chemotherapy for initially unresectable locally advanced biliary tract cancer: a retrospective single-center study. Ann Surg Oncol, 2013, 20(1): 318-324.
52.	Kato A, Shimizu H, Ohtsuka M, et al. Downsizing chemotherapy for initially unresectable locally advanced biliary tract cancer patients treated with gemcitabine plus cisplatin combination therapy followed by radical surgery. Ann Surg Oncol, 2015, 22 Suppl 3: S1093-S1099. doi: doi: 10.1245/s10434-015-4768-9.
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1. Benavides M, Antón A, Gallego J, et al. Biliary tract cancers: SEOM clinical guidelines. Clin Transl Oncol, 2015, 17(12): 982-987.
2. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
3. Lamarca A, Edeline J, McNamara MG, et al. Current standards and future perspectives in adjuvant treatment for biliary tract cancers. Cancer Treat Rev, 2020, 84: 101936. doi: 10.1016/j.ctrv.2019.101936.
4. Zhu AX, Hong TS, Hezel AF, et al. Current management of gallbladder carcinoma. Oncologist, 2010, 15(2): 168-181.
5. Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver, 2012, 6(2): 172-187.
6. Adam R, Aloia T, Lévi F, et al. Hepatic resection after rescue cetuximab treatment for colorectal liver metastases previously refractory to conventional systemic therapy. J Clin Oncol, 2007, 25(29): 4593-4602.
7. Kinoshita J, Yamaguchi T, Moriyama H, et al. Current status of conversion surgery for stage Ⅳ gastric cancer. Surg Today, 2021, 51(11): 1736-1754.
8. Tomasello G, Petrelli F, Ghidini M, et al. FOLFOXIRI plus bevacizumab as conversion therapy for patients with initially unresectable metastatic colorectal cancer: a systematic review and pooled analysis. JAMA Oncol, 2017, 3(7): e170278. doi: 10.1001/jamaoncol.2017.0278.
9. Arita J, Ichida A, Nagata R, et al. Conversion surgery after preoperative therapy for advanced hepatocellular carcinoma in the era of molecular targeted therapy and immune checkpoint inhibitors. J Hepatobiliary Pancreat Sci, 2022, 29(7): 732-740.
10. Yoshitomi H, Takano S, Furukawa K, et al. Conversion surgery for initially unresectable pancreatic cancer: current status and unresolved issues. Surg Today, 2019, 49(11): 894-906.
11. 汤朝晖, 陈家璐, 刘深洋, 等. 靶免联合治疗在胆道恶性肿瘤转化中应用的意义. 中华外科杂志, 2022, 60(4): 343-350.
12. 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.
13. Morizane C, Okusaka T, Mizusawa J, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase Ⅲ clinical trial. Ann Oncol, 2019, 30(12): 1950-1958.
14. Sharma A, Kalyan Mohanti B, Pal Chaudhary S, et al. Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: results of a phase Ⅲ randomised controlled trial. Eur J Cancer, 2019, 123: 162-170.
15. 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.
16. Ioka T, Kanai M, Kobayashi S, et al. Randomized phase Ⅲ study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401-MITSUBA). J Hepatobiliary Pancreat Sci, 2023, 30(1): 102-110.
17. Miura Y, Ashida R, Sugiura T, et al. Pathological complete response achieved by gemcitabine plus cisplatin therapy for initially unresectable advanced gallbladder cancer: a case report. Surg Case Rep, 2022, 8(1): 20. doi: 10.1186/s40792-022-01375-z.
18. Inoue M, Hakoda K, Sawada H, et al. Locally advanced gallbladder cancer treated with effective chemotherapy and subsequent curative resection: a case report. J Med Case Rep, 2022, 16(1): 30. doi: 110.1186/s13256-021-03248-9.
19. Tsuyuki H, Maruo H, Shimizu Y, et al. A case of advanced gallbladder cancer with paraaortic lymph node metastases successfully treated by chemotherapy and conversion surgery. Gan To Kagaku Ryoho, 2018, 45: 2117-2119.
20. Wakasa Y, Toyoki Y, Kusumi T, et al. Conversion surgery following gemcitabine plus cisplatin therapy for initially unresectable gallbladder cancer with peritoneal carcinomatosis: a case report. Surg Case Rep, 2022, 8(1): 50. doi: 10.1186/s40792-022-01406-9.
21. Creasy JM, Goldman DA, Dudeja V, et al. Systemic chemotherapy combined with resection for locally advanced gallbladder carcinoma: surgical and survival outcomes. J Am Coll Surg, 2017, 224(5): 906-916.
22. Noji T, Nagayama M, Imai K, et al. Conversion surgery for initially unresectable biliary malignancies: a multicenter retrospective cohort study. Surg Today, 2020, 50(11): 1409-1417.
23. Shroff RT, Guthrie KA, Scott AJ, 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: LBA490. doi: 10.1200/JCO.2023.41.6_suppl.490.
24. Yang Z, Wu Z, Xiong Y, et al. Successful conversion surgery for locally advanced gallbladder cancer after gemcitabine and nab-paclitaxel chemotherapy. Front Oncol, 2022, 12: 977963. doi: 10.3389/fonc.2022.977963.
25. Nara S, Ioka T, Ogawa G, et al. Randomized multicenter phase Ⅲ trial of neoadjuvant gemcitabine + cisplatin + S-1 (GCS) versus surgery first for resectable biliary tract cancer (JCOG1920: NABICAT). J Clin Oncol, 2023, 41(4_suppl): TPS621. doi: 10.1200/JCO.2023.41.4_suppl.TPS621.
26. Valle JW, Kelley RK, Nervi B, et al. Biliary tract cancer. Lancet, 2021, 397(10272): 428-444.
27. Duranti S, Fabi A, Filetti M, et al. Breast cancer drug approvals issued by EMA: a review of clinical trials. Cancers (Basel), 2021, 13(20): 5198. doi: 10.3390/cancers13205198.
28. Shitara K, Baba E, Fujitani K, et al. Discovery and development of trastuzumab deruxtecan and safety management for patients with HER2-positive gastric cancer. Gastric Cancer, 2021, 24(4): 780-789.
29. Meric-Bernstam F, Beeram M, Hamilton E, et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. Lancet Oncol, 2022, 23(12): 1558-1570.
30. Ohba A, Morizane C, Ueno M, et al. Multicenter phase Ⅱ trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial. Future Oncol, 2022, 18(19): 2351-2360.
31. Meric-Bernstam F, Hainsworth J, Bose R, et al. MyPathway HER2 basket study: pertuzumab (P) + trastuzumab (H) treatment of a large, tissue-agnostic cohort of patients with HER2-positive advanced solid tumors. J ClinOncol, 2021, 39(15_suppl): 3004. doi: 10.1200/JCO.2021.39.15_suppl.3004.
32. Cannon TL, Rothe M, Garrett-Mayer E, et al. Pertuzumab plus trastuzumab (P+T) in patients (pts) with biliary tract cancer (BTC) with ERBB2/3 amplification (amp), overexpression (oe), or mutation (mut): results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study. J Clin Oncol, 2023, 41(4_suppl): 546. doi: 10.1200/JCO.2023.41.4_suppl.546.
33. Oh DY, Park JO, Kim JW, et al. CTX-009 (ABL001), a bispecific antibody targeting DLL4 and VEGF A, in combination with paclitaxel in patients with advanced biliary tract cancer (BTC): a phase 2 study. J Clin Oncol, 2023, 41(4_suppl): 540. doi: 10.1200/JCO.2023.41.4_suppl.540.
34. Lamarca A, Barriuso J, McNamara MG, et al. Molecular targeted therapies: ready for “prime time” in biliary tract cancer. J Hepatol, 2020, 73(1): 170-185.
35. Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science, 2017, 357(6349): 409-413.
36. Chen XF, Wu XF, Wu H, et al. 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, 8(2): e001240. doi: 10.1136/jitc-2020-001240.
37. Oh DY, He AR, Qin S, 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. doi: 10.1200/JCO.2022.40.4_suppl.378.
38. Li W, Wang Y, Yu Y, et al. Toripalimab combined with gemcitabine and S-1 in the first-line treatment of advanced biliary tract cancer. J Clin Oncol, 2022, 40(16_suppl): 4081. doi: 10.1200/JCO.2022.40.16_suppl.4081.
39. Li X, Zhou N, Yang Y, et al. Nab-paclitaxel plus anti–PD-1 antibody as second-line treatment for advanced biliary tract cancer: an investigator-initiated phase 2 study (NapaSinti trial). J Clin Oncol, 2023, 41(4_suppl): 564. doi: 10.1200/JCO.2023.41.4_suppl.564.
40. Jin S, Zhao R, Zhou C, et al. Updated results from the phase Ⅱ study: efficacy and safety of anlotinib plus sintilimab as second-line treatment for patients with advanced biliary tract cancers. J Clin Oncol, 2023, 41(4_suppl): 577. doi: 10.1200/JCO.2023.41.4_suppl.577.
41. Chen X, Guo F, Zhang X, et al. A single-arm, open-label, phase Ⅱ study investigating anti-HER2 ADC plus anti-PD-1 antibody in patients with unresectable locally advanced or metastatic BTC with HER2 overexpression. J Clin Oncol, 2023, 41(4_suppl): TPS619. doi: 10.1200/JCO.2023.41.4_suppl.TPS619.
42. Furukawa M, Ueno M, Sakai D, et al. A multicenter, single-arm, phase Ⅱ study of nivolumab in patients with biliary tract cancer with a PD-L1 combined positive score ≥1. J Clin Oncol, 2023, 41(4_suppl): 533. doi: 10.1200/JCO.2023.41.4_suppl.533.
43. Jeong SY, Kim ST, Jang JY. The efficacy of immune checkpoint inhibitors in biliary tract cancer with KRAS mutation. J Clin Oncol, 2023, 41(4_suppl): 598. doi: 10.1200/JCO.2023.41.4_suppl.598.
44. 中华医学会外科学分会胆道外科学组, 中国医师协会外科医师分会胆道外科专业委员会. 胆囊癌诊断和治疗指南(2019版). 中华外科杂志, 2020, 58(4): 243-251.
45. Sharma A, Pramanik R, Kumar A, et al. Safety and efficacy of modified FOLFIRINOX in unresectable or metastatic gallbladder cancer: a phase Ⅱ pilot study. JCO Glob Oncol, 2021, 7: 820-826.
46. Gupta P, Meghashyam K, Marodia Y, et al. Locally advanced gallbladder cancer: a review of the criteria and role of imaging. Abdom Radiol (NY), 2021, 46(3): 998-1007.
47. Kim SJ, Lee JM, Lee JY, et al. Accuracy of preoperative T-staging of gallbladder carcinoma using MDCT. AJR Am J Roentgenol, 2008, 190(1): 74-80.
48. Tseng JH, Wan YL, Hung CF, et al. Diagnosis and staging of gallbladder carcinoma. Evaluation with dynamic MR imaging. Clin Imaging, 2002, 26(3): 177-182.
49. Lee SW, Kim HJ, Park JH, et al. Clinical usefulness of ¹⁸F-FDG PET-CT for patients with gallbladder cancer and cholangiocarcinoma. J Gastroenterol, 2010, 45(5): 560-566.
50. Sachan A, Saluja SS, Nekarakanti PK, et al. Raised CA19-9 and CEA have prognostic relevance in gallbladder carcinoma. BMC Cancer, 2020, 20(1): 826. doi: 10.1186/s12885-020-07334-x.
51. Kato A, Shimizu H, Ohtsuka M, et al. Surgical resection after downsizing chemotherapy for initially unresectable locally advanced biliary tract cancer: a retrospective single-center study. Ann Surg Oncol, 2013, 20(1): 318-324.
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