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The role of hyperthermic intraperitoneal chemotherapy (HIPEC) has been acknowledged as prophylaxis for peritoneal carcinomatosis (PC) in AGC patients and in this study, we aim at investigating the safety and efficacy of the combination of neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC in the neoadjuvant phase followed by surgery of curative intent with intraoperative HIPEC followed by adjuvant chemotherapy (AC).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this multicenter Phase III randomized controlled trial, 326 patients will be randomly separated into 2 groups into a 1:1 ratio after laparoscopic exploration. The experiment arm will receive the proposed comprehensive Dragon II regimen while the control group will undergo standard R0 D2 followed by 8\u2009cycles of AC with oxaliplatin with S-1 (SOX) regimen. The Dragon II regimen comprises of 1 cycle of NLHIPEC for 60mins at 43\u2009\u00b1\u20090.5\u2009\u00b0C with 80\u2009mg\/m<jats:sup>2<\/jats:sup> of Paclitaxel followed by 3 cycles of NAC with SOX regimen and after assessment, standard R0 D2 gastrectomy with intraoperative HIPEC followed by 5\u2009cycles of SOX regimen chemotherapy. The end-points for the study are 5\u2009year PFS, 5\u2009year OS, peritoneal metastasis rate (PMR) and morbidity rate.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This study is one of the first to combine NLHIPEC with NAC in the preoperative phase which is speculated to provide local management of occult peritoneal carcinomatosis or peritoneal free cancer cells while NAC will promote tumor downsizing and down-staging. The addition of the intraoperative HIPEC is speculated to manage dissemination due to surgical trauma. Where the roles of intraoperative HIPEC and NAC have individually been investigated, this study provides innovative insight on a more comprehensive approach to management of AGC at high risk of peritoneal recurrence. It is expected that the combination of NLHIPEC with NAC and HIPEC will increase PFS by 15% and decrease PMR after gastrectomy of curative intent.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>World Health Organization Clinical Trials - International Registry Platform (WHO-ICTRP) with Registration ID <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/showprojen.aspx?proj=40134\">ChiCTR1900024552<\/jats:ext-link>, Registered Prospectively on the 16th July, 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12885-020-6701-2","type":"journal-article","created":{"date-parts":[[2020,3,17]],"date-time":"2020-03-17T06:03:08Z","timestamp":1584424988000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Study protocol of a multicenter phase III randomized controlled trial investigating the efficiency of the combination of neoadjuvant chemotherapy (NAC) and neoadjuvant laparoscopic intraperitoneal hyperthermic chemotherapy (NLHIPEC) followed by R0 gastrectomy with intraoperative HIPEC for advanced gastric cancer (AGC): dragon II trial"],"prefix":"10.1186","volume":"20","author":[{"given":"Maneesh Kumarsing","family":"Beeharry","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen-Tian","family":"Ni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhong Yin","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya Nan","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Run Hua","family":"Feng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Tao","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xue Xin","family":"Yao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zheng-Gang","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,17]]},"reference":[{"issue":"6","key":"6701_CR1","doi-asserted-by":"publisher","first-page":"394","DOI":"10.3322\/caac.21492","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. 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All participating subjects will sign the written consent form.The participating centres are:Ruijin Hospital Affiliated to Shanghai Jiaotong University School of MedicineXinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai First People\u2019s HospitalHuashan Hospital Affiliated to Fudan UniversityEast China Hospital Affiliated to Fudan UniversityRuijin Hospital North Affiliated to Shanghai Jiaotong University School of MedicineShanghai Changzheng HospitalThe Second Affiliated Hospital of Zhejiang University Medical CollegeTaizhou Tumor HospitalZhejiang Tumor HospitalNingbo First HospitalZhejiang People\u2019s HospitalThe Second Affiliated Hospital of Suzhou UniversityJiangsu People\u2019s HospitalAffiliated Hospital of Xuzhou Medical UniversityThe Second People\u2019s Hospital of WuxiSubei People\u2019s Hospital of Jiangsu ProvinceZhongda Hospital affiliated to Southeast UniversityJiangsu Cancer HospitalThe First Affiliated Hospital of Suzhou UniversityAs per Ethics\u2019 committee requirement, once the main centre has cleared Ethics approval, the other centres have registered the trial independently in their respective faculties.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The consent form for the subjects contains the clause \u201cConsent to publish results\u201d to which each participating subjects will provide consent before inclusion in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"224"}}