{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:58:08Z","timestamp":1777593488750,"version":"3.51.4"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,12,2]],"date-time":"2022-12-02T00:00:00Z","timestamp":1669939200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,12,2]],"date-time":"2022-12-02T00:00:00Z","timestamp":1669939200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["16lk0201052h"],"award-info":[{"award-number":["16lk0201052h"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The Tokyo University Research Fund"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Invest New Drugs"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>\nGiven the promising activity and tolerability of FOLFIRINOX as a second-line treatment for advanced biliary tract cancer (BTC), it can be an attractive first-line treatment option as well.\nThis is a single-arm, open-label, multicenter phase II study to evaluate the safety and efficacy of FOLFIRINOX as a first-line treatment for patients with advanced BTC. Primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall survival (OS), tumor response and safety. This study defined primary endpoint might be met when the lower limit value of 80% confidence interval [CI] of the median PFS\u2009\u2265\u20096.0\u00a0months.\nBetween June 2016 and March 2020, 35 BTC patients (21 intrahepatic, 10 extrahepatic, 2 gallbladder, 2 ampulla) including 26 unresectable and 9 recurrent disease were enrolled. After a median follow-up of 13.9\u00a0months, the median PFS and OS were 7.4 (80% CI, 5.5\u20137.5) and 14.7 (80% CI, 11.8\u201315.7) months, respectively. Complete response was achieved in 1 (2.9%) and partial response in 10 (28.6%), giving an objective response rate of 31.4% and disease control rate of 74.3%. Major grade 3\u20134 adverse events included neutropenia (54.3%), leukopenia (34.4%), febrile neutropenia (17.1%), thrombocytopenia (8.6%), cholangitis (8.6%), anemia, nausea, diarrhea, and peripheral sensory neuropathy (2.9% each).\nFOLFIRINOX was well tolerable in patients with advanced BTC, however, this study did not meet the primary endpoint to conduct a phase III trial. Thus, further explorations are required to find a subset of patients and\/or certain clinical scenario which might be beneficial from FOLFIRINOX.\n<\/jats:p>","DOI":"10.1007\/s10637-022-01322-7","type":"journal-article","created":{"date-parts":[[2022,12,2]],"date-time":"2022-12-02T16:33:10Z","timestamp":1669998790000},"page":"76-85","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer"],"prefix":"10.1007","volume":"41","author":[{"given":"Naminatsu","family":"Takahara","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yousuke","family":"Nakai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Isayama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Morine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuo","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Ueno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Ioka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Kanai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shunsuke","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naohiro","family":"Okano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Koike","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,12,2]]},"reference":[{"issue":"1","key":"1322_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s00534-008-0015-0","volume":"16","author":"S Miyakawa","year":"2009","unstructured":"Miyakawa S, Ishihara S, Horiguchi A, Takada T, Miyazaki M, Nagakawa T (2009) Biliary tract cancer treatment: 5,584 results from the Biliary Tract Cancer Statistics Registry from 1998 to 2004 in Japan. J Hepatobiliary Pancreat Surg 16(1):1\u20137","journal-title":"J Hepatobiliary Pancreat Surg"},{"issue":"5","key":"1322_CR2","doi-asserted-by":"publisher","first-page":"755","DOI":"10.1097\/01.sla.0000251366.62632.d3","volume":"245","author":"ML DeOliveira","year":"2007","unstructured":"DeOliveira ML, Cunningham SC, Cameron JL, Kamangar F, Winter JM, Lillemoe KD et al (2007) Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution. Ann Surg 245(5):755\u2013762","journal-title":"Ann Surg"},{"issue":"14","key":"1322_CR3","doi-asserted-by":"publisher","first-page":"1273","DOI":"10.1056\/NEJMoa0908721","volume":"362","author":"J Valle","year":"2010","unstructured":"Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362(14):1273\u20131281","journal-title":"N Engl J Med"},{"issue":"4","key":"1322_CR4","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1038\/sj.bjc.6605779","volume":"103","author":"T Okusaka","year":"2010","unstructured":"Okusaka T, Nakachi K, Fukutomi A, Mizuno N, Ohkawa S, Funakoshi A et al (2010) Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer 103(4):469\u2013474","journal-title":"Br J Cancer"},{"issue":"6","key":"1322_CR5","doi-asserted-by":"publisher","first-page":"1429","DOI":"10.1007\/s00280-010-1443-5","volume":"67","author":"M Kanai","year":"2011","unstructured":"Kanai M, Yoshimura K, Tsumura T, Asada M, Suzuki C, Niimi M et al (2011) A multi-institution phase II study of gemcitabine\/S-1 combination chemotherapy for patients with advanced biliary tract cancer. Cancer Chemother Pharmacol 67(6):1429\u20131434","journal-title":"Cancer Chemother Pharmacol"},{"issue":"4","key":"1322_CR6","doi-asserted-by":"publisher","first-page":"973","DOI":"10.1007\/s00280-013-2090-4","volume":"71","author":"T Sasaki","year":"2013","unstructured":"Sasaki T, Isayama H, Nakai Y, Ito Y, Yasuda I, Toda N et al (2013) A randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine monotherapy for advanced biliary tract cancer. Cancer Chemother Pharmacol 71(4):973\u2013979","journal-title":"Cancer Chemother Pharmacol"},{"issue":"3","key":"1322_CR7","doi-asserted-by":"publisher","first-page":"269","DOI":"10.1007\/s10637-017-0430-7","volume":"35","author":"N Takahara","year":"2017","unstructured":"Takahara N, Isayama H, Nakai Y, Sasaki T, Ishigaki K, Saito K et al (2017) Gemcitabine and S-1 versus gemcitabine and cisplatin treatment in patients with advanced biliary tract cancer: a multicenter retrospective study. Invest New Drugs 35(3):269\u2013276","journal-title":"Invest New Drugs"},{"key":"#cr-split#-1322_CR8.1","doi-asserted-by":"crossref","unstructured":"Sakai D KM, Kobayashi S, Eguchi H, Baba H, Seo S et al (2018) Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin","DOI":"10.1093\/annonc\/mdy282"},{"key":"#cr-split#-1322_CR8.2","unstructured":"(GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). 2018 ESMO Annual Meeting 6150"},{"issue":"12","key":"1322_CR9","doi-asserted-by":"publisher","first-page":"1950","DOI":"10.1093\/annonc\/mdz402","volume":"30","author":"C Morizane","year":"2019","unstructured":"Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M et al (2019) Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced\/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Annals of oncology\u202f: official journal of the European Society for Medical Oncology \/ ESMO 30(12):1950\u20131958","journal-title":"Annals of oncology : official journal of the European Society for Medical Oncology \/ ESMO"},{"issue":"2","key":"1322_CR10","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1016\/S1470-2045(11)70301-1","volume":"13","author":"J Lee","year":"2012","unstructured":"Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA et al (2012) Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 13(2):181\u2013188","journal-title":"Lancet Oncol"},{"issue":"8","key":"1322_CR11","doi-asserted-by":"publisher","first-page":"967","DOI":"10.1016\/S1470-2045(15)00139-4","volume":"16","author":"JW Valle","year":"2015","unstructured":"Valle JW, Wasan H, Lopes A, Backen AC, Palmer DH, Morris K et al (2015) Cediranib or placebo in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer (ABC-03): a randomised phase 2 trial. Lancet Oncol 16(8):967\u2013978","journal-title":"Lancet Oncol"},{"issue":"4","key":"1322_CR12","doi-asserted-by":"publisher","first-page":"574","DOI":"10.1002\/cncr.29778","volume":"122","author":"F Leone","year":"2016","unstructured":"Leone F, Marino D, Cereda S, Filippi R, Belli C, Spadi R et al (2016) Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study). Cancer 122(4):574\u2013581","journal-title":"Cancer"},{"issue":"5","key":"1322_CR13","doi-asserted-by":"publisher","first-page":"671","DOI":"10.1016\/S1470-2045(20)30109-1","volume":"21","author":"GK Abou-Alfa","year":"2020","unstructured":"Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R et al (2020) Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol 21(5):671\u2013684","journal-title":"Lancet Oncol"},{"issue":"6","key":"1322_CR14","doi-asserted-by":"publisher","first-page":"796","DOI":"10.1016\/S1470-2045(20)30157-1","volume":"21","author":"GK Abou-Alfa","year":"2020","unstructured":"Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J et al (2020) Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 21(6):796\u2013807","journal-title":"Lancet Oncol"},{"issue":"9","key":"1322_CR15","doi-asserted-by":"publisher","first-page":"943","DOI":"10.1158\/2159-8290.CD-17-0245","volume":"7","author":"JW Valle","year":"2017","unstructured":"Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu AX (2017) New Horizons for Precision Medicine in Biliary Tract Cancers. Cancer Discov 7(9):943\u2013962","journal-title":"Cancer Discov"},{"issue":"5","key":"1322_CR16","doi-asserted-by":"publisher","first-page":"690","DOI":"10.1016\/S1470-2045(21)00027-9","volume":"22","author":"A Lamarca","year":"2021","unstructured":"Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A et al (2021) 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 22(5):690\u2013701","journal-title":"Lancet Oncol"},{"issue":"11","key":"1322_CR17","doi-asserted-by":"publisher","first-page":"1560","DOI":"10.1016\/S1470-2045(21)00486-1","volume":"22","author":"C Yoo","year":"2021","unstructured":"Yoo C, Kim KP, Jeong JH, Kim I, Kang MJ, Cheon J et al (2021) Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study. Lancet Oncol 22(11):1560\u20131572","journal-title":"Lancet Oncol"},{"key":"1322_CR18","doi-asserted-by":"crossref","unstructured":"Phelip JM, Desrame J, Edeline J, Barbier E, Terrebonne E, Michel P et al (2021) Modified FOLFIRINOX Versus CISGEM Chemotherapy for Patients With Advanced Biliary Tract Cancer (PRODIGE 38 AMEBICA): A Randomized Phase II Study. J Clin Oncol: Official J Am Soc Clin Oncol JCO2100679","DOI":"10.1200\/JCO.21.00679"},{"key":"1322_CR19","doi-asserted-by":"publisher","first-page":"820","DOI":"10.1200\/GO.20.00657","volume":"7","author":"A Sharma","year":"2021","unstructured":"Sharma A, Pramanik R, Kumar A, Pathy S, Kumar S, Bhoriwal S et al (2021) Safety and Efficacy of Modified FOLFIRINOX in Unresectable or Metastatic Gallbladder Cancer: A Phase II Pilot Study. JCO Glob Oncol 7:820\u2013826","journal-title":"JCO Glob Oncol"},{"issue":"1","key":"1322_CR20","doi-asserted-by":"publisher","first-page":"515","DOI":"10.1186\/s12885-020-07004-y","volume":"20","author":"A Ulusakarya","year":"2020","unstructured":"Ulusakarya A, Karaboue A, Ciacio O, Pittau G, Haydar M, Biondani P et al (2020) A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer. BMC Cancer 20(1):515","journal-title":"BMC Cancer"},{"issue":"4","key":"1322_CR21","doi-asserted-by":"publisher","first-page":"498","DOI":"10.21037\/hbsn-20-846","volume":"10","author":"XY Cui","year":"2021","unstructured":"Cui XY, Li XC, Cui JJ, Wu XS, Zou L, Song XL et al (2021) Modified FOLFIRINOX for unresectable locally advanced or metastatic gallbladder cancer, a comparison with GEMOX regimen. Hepatobiliary Surg Nutr 10(4):498\u2013506","journal-title":"Hepatobiliary Surg Nutr"},{"issue":"1","key":"1322_CR22","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1186\/s12885-021-08549-2","volume":"21","author":"L Zou","year":"2021","unstructured":"Zou L, Li X, Wu X, Cui J, Cui X, Song X et al (2021) Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study. BMC Cancer 21(1):818","journal-title":"BMC Cancer"},{"issue":"5","key":"1322_CR23","doi-asserted-by":"publisher","first-page":"634","DOI":"10.1038\/s41416-019-0698-9","volume":"122","author":"A Belkouz","year":"2020","unstructured":"Belkouz A, de Vos-Geelen J, Mathot RAA, Eskens F, van Gulik TM, van Oijen MGH et al (2020) Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial. Br J Cancer 122(5):634\u2013639","journal-title":"Br J Cancer"},{"issue":"3","key":"1322_CR24","doi-asserted-by":"publisher","first-page":"836","DOI":"10.1007\/s10637-020-01045-7","volume":"39","author":"LF Ye","year":"2021","unstructured":"Ye LF, Ren C, Bai L, Liang JY, Hu MT, Yang H et al (2021) Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study. Invest New Drugs 39(3):836\u2013845","journal-title":"Invest New Drugs"},{"key":"1322_CR25","doi-asserted-by":"crossref","unstructured":"Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228\u201347","DOI":"10.1016\/j.ejca.2008.10.026"},{"issue":"19","key":"1322_CR26","doi-asserted-by":"publisher","first-page":"1817","DOI":"10.1056\/NEJMoa1011923","volume":"364","author":"T Conroy","year":"2011","unstructured":"Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y et al (2011) FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 364(19):1817\u20131825","journal-title":"N Engl J Med"},{"issue":"1","key":"1322_CR27","doi-asserted-by":"publisher","first-page":"6738","DOI":"10.1038\/s41467-021-27099-6","volume":"12","author":"P Carotenuto","year":"2021","unstructured":"Carotenuto P, Amato F, Lampis A, Rae C, Hedayat S, Previdi MC et al (2021) Modulation of pancreatic cancer cell sensitivity to FOLFIRINOX through microRNA-mediated regulation of DNA damage. Nat Commun 12(1):6738","journal-title":"Nat Commun"},{"key":"1322_CR28","doi-asserted-by":"crossref","unstructured":"Capello M, Lee M, Wang H, Babel I, Katz MH, Fleming JB et al (2015) Carboxylesterase 2 as a Determinant of Response to Irinotecan and Neoadjuvant FOLFIRINOX Therapy in Pancreatic Ductal Adenocarcinoma. J Natl Cancer Inst 107(8)","DOI":"10.1093\/jnci\/djv132"},{"issue":"24","key":"1322_CR29","doi-asserted-by":"publisher","first-page":"6204","DOI":"10.1158\/1078-0432.CCR-18-1472","volume":"24","author":"A Sehdev","year":"2018","unstructured":"Sehdev A, Gbolahan O, Hancock BA, Stanley M, Shahda S, Wan J et al (2018) Germline and Somatic DNA Damage Repair Gene Mutations and Overall Survival in Metastatic Pancreatic Adenocarcinoma Patients Treated with FOLFIRINOX. Clin Cancer Res 24(24):6204\u20136211","journal-title":"Clin Cancer Res"},{"issue":"9","key":"1322_CR30","doi-asserted-by":"publisher","first-page":"1003","DOI":"10.1038\/ng.3375","volume":"47","author":"H Nakamura","year":"2015","unstructured":"Nakamura H, Arai Y, Totoki Y, Shirota T, Elzawahry A, Kato M et al (2015) Genomic spectra of biliary tract cancer. Nat Genet 47(9):1003\u20131010","journal-title":"Nat Genet"},{"key":"1322_CR31","doi-asserted-by":"publisher","first-page":"122","DOI":"10.1016\/j.ejca.2017.10.013","volume":"87","author":"L Verlingue","year":"2017","unstructured":"Verlingue L, Malka D, Allorant A, Massard C, Ferte C, Lacroix L et al (2017) Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial. Eur J Cancer 87:122\u2013130","journal-title":"Eur J Cancer"},{"issue":"9","key":"1322_CR32","doi-asserted-by":"publisher","first-page":"1405","DOI":"10.1001\/jamaoncol.2020.2814","volume":"6","author":"O Klein","year":"2020","unstructured":"Klein O, Kee D, Nagrial A, Markman B, Underhill C, Michael M et al (2020) Evaluation of Combination Nivolumab and Ipilimumab Immunotherapy in Patients With Advanced Biliary Tract Cancers: Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial. JAMA Oncol 6(9):1405\u20131409","journal-title":"JAMA Oncol"},{"issue":"8","key":"1322_CR33","doi-asserted-by":"publisher","first-page":"611","DOI":"10.1016\/S2468-1253(19)30086-X","volume":"4","author":"M Ueno","year":"2019","unstructured":"Ueno M, Ikeda M, Morizane C, Kobayashi S, Ohno I, Kondo S et al (2019) 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 4(8):611\u2013621","journal-title":"Lancet Gastroenterol Hepatol"},{"issue":"6","key":"1322_CR34","doi-asserted-by":"publisher","first-page":"888","DOI":"10.1001\/jamaoncol.2020.0930","volume":"6","author":"RD Kim","year":"2020","unstructured":"Kim RD, Chung V, Alese OB, El-Rayes BF, Li D, Al-Toubah TE et al (2020) A Phase 2 Multi-institutional Study of Nivolumab for Patients With Advanced Refractory Biliary Tract Cancer. JAMA Oncol 6(6):888\u2013894","journal-title":"JAMA Oncol"},{"issue":"2","key":"1322_CR35","doi-asserted-by":"publisher","first-page":"594","DOI":"10.4143\/crt.2019.493","volume":"52","author":"J Kang","year":"2020","unstructured":"Kang J, Jeong JH, Hwang HS, Lee SS, Park DH, Oh DW et al (2020) Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. Cancer research and treatment\u202f: official journal of Korean Cancer Association 52(2):594\u2013603","journal-title":"Cancer research and treatment : official journal of Korean Cancer Association"},{"key":"1322_CR36","doi-asserted-by":"publisher","unstructured":"Oh DY HA, Qin S, Chen LT, Okusaka T, Vogel A (2022) Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid\u00a01(8). https:\/\/doi.org\/10.1056\/EVIDoa2200015","DOI":"10.1056\/EVIDoa2200015"},{"issue":"6","key":"1322_CR37","doi-asserted-by":"publisher","first-page":"1017","DOI":"10.1007\/s00280-018-3577-9","volume":"81","author":"M Ozaka","year":"2018","unstructured":"Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K et al (2018) A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol 81(6):1017\u20131023","journal-title":"Cancer Chemother Pharmacol"}],"container-title":["Investigational New Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-022-01322-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10637-022-01322-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-022-01322-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T13:08:54Z","timestamp":1679404134000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10637-022-01322-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,2]]},"references-count":38,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["1322"],"URL":"https:\/\/doi.org\/10.1007\/s10637-022-01322-7","relation":{},"ISSN":["0167-6997","1573-0646"],"issn-type":[{"value":"0167-6997","type":"print"},{"value":"1573-0646","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,2]]},"assertion":[{"value":"17 September 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 November 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 December 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was approved by the University of Tokyo, Clinical Research Review Board and was carried out in accordance with the guidelines for Good Clinical Practice.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all participants.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All authors approved for the publication.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Yousuke Nakai receives research fund from Taiho Pharma. Hiroyuki Isayama receives research fund from Yakult Honsha Co., Ltd. MU receives lecture fees, honoraria, or other fees from Yakult Honsha Co., Ltd. and research fund from Yakult Honsha Co., Ltd. Tatsuya Ioka receives lecture fees, honoraria, or other fees from Taiho Pharma and Ono pharmaceutical Co., Ltd. Masashi Kanai receives profit from shares of Therabiopharma Inc. and lecture fees, honoraria, or other fees from Chugai Pharmaceutical Co., Ltd. and research fund from Molecular health.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}]}}