上海Amivantamab注射液（皮下注射）III期临床试验-一项在复发性/转移性头颈癌受试者中比较Amivantamab联合标准治疗药物(SOC)与单用SOC的研究(OrigAMI-5)

登记号	CTR20254647	试验状态	进行中
申请人联系人	杨佑琦	首次公示信息日期	2025-11-14
申请人名称	Janssen Research & Development, LLC/ 强生（中国）投资有限公司/ Cilag AG/ Janssen Research & Development, A Division of Janssen Pharmaceutica NV; Fisher Clinical Services.; Fisher Clinical Services; Catalent Pharma Solutions LLC; Almac Clinical Services; Almac Clinical Services

登记号	CTR20254647
相关登记号	暂无
药物名称	Amivantamab注射液（皮下注射）
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	头颈部鳞状细胞癌
试验专业题目	一项在复发性/转移性头颈部鳞状细胞癌初治受试者中比较Amivantamab和卡铂及帕博利珠单抗联合治疗对比标准治疗帕博利珠单抗和铂类药物及5-FU联合治疗的随机、开放性、多中心III期研究
试验通俗题目	一项在复发性/转移性头颈癌受试者中比较Amivantamab联合标准治疗药物(SOC)与单用SOC的研究(OrigAMI-5)
试验方案编号	61186372HNC3001	方案最新版本号	原始版本
版本日期:	2025-07-23	方案是否为联合用药	否

申请人名称	[["Janssen Research & Development, LLC"],["强生（中国）投资有限公司"],["Cilag AG"],["Janssen Research & Development, A Division of Janssen Pharmaceutica NV; Fisher Clinical Services.; Fisher Clinical Services; Catalent Pharma Solutions LLC; Almac Clinical Services; Almac Clinical Services"]]
联系人姓名	杨佑琦	联系人座机	021-33376008	联系人手机号
联系人Email	yyang258@its.jnj.com	联系人邮政地址	上海市-上海市-徐汇区桂箐路65号新研大厦A楼	联系人邮编	200233

本研究的目的是在难治性/转移性(R/M)头颈部鳞状细胞癌(HNSCC)受试者中比较amivantamab联合帕博利珠单抗和卡铂与帕博利珠单抗、5-氟尿嘧啶和铂类治疗（卡铂或顺铂）的抗肿瘤活性。HNSCC是一种发生在头颈部区域的癌症，包括口腔和咽喉的外组织层。本研究将重点关注R/M环境中初治（既往未接受过治疗）的HNSCC受试者。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["≥18岁（或研究开展地区法定成年年龄，以较大者为准）。"],["东部肿瘤协作组(ECOG)体能状态评分为0或1。"],["具有组织学或细胞学证实的复发或转移性(R/M)头颈部鳞状细胞癌(HNSCC)，且局部治疗无法治愈：a.合格的原发肿瘤部位为口腔、口咽、下咽或喉；b.原发肿瘤部位不得为鼻咽部或原发不明；c.必须记录当地法规规定的检测结果；d.必须通过p16检测、HPV脱氧核糖核酸(DNA)检测了解原发肿瘤部位为口咽的受试者的人乳头瘤病毒(HPV)状态，或高危型HPV原位杂交(ISH)结果。任何已知的肿瘤p16、HPV DNA或高危型HPV ISH状态必须为阴性。"],["未接受过针对R/M的系统性治疗。受试者在局部晚期疾病根治性全身治疗完成后6个月内不得出现疾病进展。"],["根据实体瘤疗效评价标准(RECIST)(v)1.1版具有可测量病灶。"],["同意按照研究方案规定的质量标准进行筛选活检或提供存档组织样本。"],["在研究治疗期间和研究治疗末次给药后10个月内，受试者必须：n-不得哺乳或妊娠。n-不得捐献配子（即卵子或精子）或冷冻用于将来的辅助生殖目的。n-佩戴外部避孕套。n-如果有生育能力，受试者必须：n筛选时和研究治疗首次给药前72小时内，高灵敏度（例如，β-人绒毛膜促性腺激素[β-hCG]）血清妊娠试验结果必须为阴性，且必须同意进一步进行妊娠试验。n采取至少1种高效避孕方法；如果使用口服避孕药，还必须使用屏障避孕法。n-如果受试者的伴侣有生育能力，则其伴侣必须采取高效避孕方法，除非受试者已行输精管切除术。"],["必须签署知情同意书(ICF)，表明受试者理解本研究的目的和所需程序。"],["必须愿意且能够遵守研究方案中规定的生活方式限制。"]]
排除标准	[["患有研究方案中规定的未控制的疾病。"],["有未经治疗的脑转移或已知存在软脑膜疾病史。"],["有（非感染性）间质性肺疾病(ILD)/间质性肺炎/肺纤维化病史，目前患有ILD/间质性肺炎，或筛选时影像学不能排除疑似ILD/间质性肺炎/肺纤维化。"],["有临床意义的心血管疾病史。"],["根据方案定义的参数，具有充分的肾功能。"],["根据研究方案规定的参数，具有足够的肝功能和血液学数值。"],["甲状腺功能实验室检查值不在正常范围内。"],["活动性感染性肝炎：乙型肝炎血清反应阳性、已知丙型肝炎感染或其他临床活动性感染性肝病。"],["慢性非感染性肝病现病史或既往史。"],["既往患有恶性肿瘤（除研究疾病外），其自然史或治疗可能干扰研究治疗安全性或疗效的任何研究终点。"],["已知对以下赋形剂过敏、有超敏反应、禁忌症或不耐受：Amivantamab、Pembrolizumab、卡铂、顺铂、5-氟尿嘧啶(5-FU)和透明质酸酶。"],["目前或将来有以下任何一项：n-在研究治疗首次给药前4周内接受进入体腔的创伤性手术操作，包括饲管放置和气管造口术，或未完全恢复。n-研究治疗首次给药前3周内发生重大创伤性损伤（所有伤口必须在第1周期第1天[C1D1]前完全愈合）。n-预期在研究药物给药期间或研究治疗末次给药后6个月内接受大手术。"],["在研究治疗首次给药前7天内接受过任何禁用治疗，包括免疫抑制药物。"],["既往抗癌治疗的毒性应在研究治疗首次给药前消退至基线水平或≤1级（脱发或放疗后皮肤变化[任何级别]、小于或等于[≤]2级周围神经病变和激素替代治疗期间保持稳定的 < = 2级甲状腺功能减退症除外）。"],["在研究治疗期间、研究治疗首次给药前30天内使用过活疫苗或减毒活疫苗。"],["需要使用研究期间不能停用、替代或暂时中断的禁用药物。"],["在研究治疗首次给药前2周内接受过放疗。"],["在计划的研究治疗首次给药前6周内使用过侵入性试验性医疗器械或接受过试验性药物（包括试验性疫苗），或目前已入组一项试验性研究。"],["HIV阳性受试者只有符合研究方案规定的标准才有资格参加研究。"],["存在研究者认为参加本研究并非受试者最佳选择（例如损害健康）或者影响、限制或混淆研究方案评估的任何病症。"]]

试验药

[["中文通用名:埃万妥单抗 英文通用名:Amivantamab 商品名称:NA","剂型:皮下注射（SC） 规格:Amivantamab联合重组人透明质酸酶PH20（rHuPH20） 用法用量:受试者（根据体重）接受埃万妥单抗SC的治疗时间最长为24个月 用药时程:受试者接受埃万妥单抗SC的治疗时间最长为24个月"]] 序号 名称 用法

对照药

[["中文通用名:帕博利珠单抗 英文通用名:pembrolizumab 商品名称:可瑞达","剂型:静脉注射 规格:25mg/mL 用法用量:受试者将接受帕博利珠单抗注射 用药时程:受试者接受帕博利珠单抗的治疗时间最长为24个月"],["中文通用名:卡铂 英文通用名:carboplatin 商品名称:NA","剂型:静脉注射 规格:10mg/mL 用法用量:受试者将接受卡铂 用药时程:受试者将接受卡铂"],["中文通用名:顺铂 英文通用名:cisplatin 商品名称:NA","剂型:静脉注射 规格:1mg/mL 用法用量:受试者将根据体表面积接受顺铂用药 用药时程:受试者将接受顺铂用药"],["中文通用名:5-氟尿嘧啶 英文通用名:5-fluorouracil 商品名称:NA","剂型:静脉注射 规格:50mg/mL 用法用量:受试者将根据体表面积接受持续四天的5-氟尿嘧啶用药 用药时程:受试者将接受5-氟尿嘧啶用药"]] 序号 名称 用法

主要终点指标及评价时间

[["总生存期 (OS)","最长约3年7个月","有效性指标+安全性指标"],["盲态独立中心审查委员会(BICR)根据实体瘤疗效评价标准(RECIST)1.1版评估的客观缓解率(ORR)","最长约3年7个月","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["BICR根据RECIST 1.1版评估的无进展生存期(PFS)","最长约3年7个月","有效性指标"],["BICR评估的缓解持续时间(DOR)","最长约3年7个月","有效性指标"],["研究者评估的ORR","最长约3年7个月","有效性指标"],["出现治疗期间不良事件(TEAE)的受试者数量","最长约3年7个月","安全性指标"],["实验室检查异常的受试者数量","最长约3年7个月","安全性指标"],["通过欧洲癌症研究与治疗组织生活质量问卷头颈部模块43(EORTC QLQ-HN43)症状量表评分测量，与基线相比，症状改善或稳定的受试者百分比","基线，最长约3年7个月","有效性指标+安全性指标"],["通过EORTC QLQ-Core(C)30症状量表评分测量的与基线相比症状改善或稳定的受试者百分比","基线，最长约3年7个月","有效性指标+安全性指标"],["通过EORTC QLQ-C30功能量表测量的健康相关生活质量(HRQoL)功能较基线的变化","基线，最长约3年7个月","有效性指标+安全性指标"],["通过EORTC QLQ-C30的总体健康量表测量的总体HRQoL较基线的变化","基线，最长约3年7个月","有效性指标+安全性指标"],["EORTC生活质量(QLG)项目库-46(IL-46)耐受性量表评分的治疗组间差异（A组和B组）","最长约3年7个月","有效性指标+安全性指标"],["Amivantamab的血清浓度","最长约3年7个月","有效性指标+安全性指标"],["具有血清抗Amivantamab抗体的受试者数量","最长约3年7个月","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	郭晔	学位	医学博士	职称	主任医师
	电话	021-38804518	Email	pattrickguo@gmail.com	邮政地址	上海市-上海市-浦东新区云台路1800号
	邮编	200123	单位名称	上海市东方医院

[["上海市东方医院","郭晔","中国","上海市","上海市"],["华中科技大学同济医学院附属协和医院","杨坤禹","中国","湖北省","武汉市"],["四川大学华西医院","刘磊","中国","四川省","成都市"],["北京肿瘤医院","孙艳","中国","北京市","北京市"],["复旦大学附属肿瘤医院","季冬梅","中国","上海市","上海市"],["临沂市肿瘤医院","黄丙俭","中国","山东省","临沂市"],["中国医学科学院肿瘤医院","桂琳","中国","北京市","北京市"],["华中科技大学同济医学院附属同济医院","胡广原","中国","湖北省","武汉市"],["东莞市人民医院","刘志刚","中国","广东省","东莞市"],["上海交通大学医学院附属上海第九人民医院","朱国培","中国","上海市","上海市"],["浙江省肿瘤医院","方美玉","中国","浙江省","杭州市"],["首都医科大学附属北京同仁医院","陈晓红","中国","北京市","北京市"],["广西医科大学附属肿瘤医院","曲颂","中国","广西壮族自治区","桂林市"],["云南省肿瘤医院","孙传政","中国","云南省","昆明市"],["中山大学肿瘤防治中心","李志铭","中国","广东省","广州市"],["山东第一医科大学附属肿瘤医院","胡漫","中国","山东省","济南市"],["西安交通大学医学院第一附属医院","刘锐","中国","陕西省","西安市"],["蚌埠医学院第一附属医院","江浩","中国","安徽省","蚌埠市"],["中南大学湘雅二医院","马进安","中国","湖南省","长沙市"],["重庆市肿瘤医院","吴剑","中国","重庆市","重庆市"],["四川省肿瘤医院","张石川","中国","四川省","成都市"],["宜宾市第二人民医院","杜雷亚","中国","四川省","宜宾市"],["四川省人民医院","胡洪林","中国","四川省","成都市"],["南京鼓楼医院","孔炜伟","中国","江苏省","南京市"],["武汉大学中南医院","钟亚华","中国","湖北省","武汉市"],["湖南省肿瘤医院","韩亚骞","中国","湖南省","长沙市"],["Taipei Veterans General Hospital","Muh-hwa Yang","中国台湾","台湾省","台北"],["China Medical University Hospital","Ching Yun Hsieh","中国台湾","台湾省","台中"],["Kaohsiung Chang Gung Memorial Hospital","Shau-hsuan Li","中国台湾","台湾省","高雄"],["Kaohsiung Medical University Chung Ho Memorial Hospital","Hui-ching Wang","中国台湾","台湾省","高雄"],["National Taiwan University Hospital","Hsiang-fong Kao","中国台湾","台湾省","台北"],["National Cheng Kung University Hospital","Chia-jui Yen","中国台湾","台湾省","台南"],["Changhua Christian Hospital","Jin-ching Lin","中国台湾","台湾省","彰化"],["GenesisCare","Adrian Lee","澳大利亚","NSW","St Leonards"],["St John of God Hospital Murdoch","Rajanikar Tota","澳大利亚","WA","Murdoch"],["Liverpool Hospital","Victoria Bray","澳大利亚","NSW","Liverpool"],["Peter MacCallum Cancer Centre","Annette Lim","澳大利亚","VIC","Melbourne"],["Monash Medical Centre","Daphne Day","澳大利亚","Victoria","Clayton"],["Muni Seva Ashram Goraj","Santhosh Vandanasetti","印度","GJ","Goraj"],["Bhagwan Mahaveer Cancer Hospital & Research Centre","Deepak Gupta","印度","Rajasthan","Jaipur"],["HealthCare Global HCG Manavata Cancer Centre","Rajnish Nagarkar","印度","Maharashtra","Nashik"],["All India Institute of Medical Sciences","Chethan Rajegowda","印度","DL","New Delhi"],["Chittaranjan National Cancer Institute (CNCI)","Kalyan Mukherjee","印度","WB","Kolkata"],["Apollo Speciality Hospital, Chennai","Thirumalairaj Raja","印度","Tamil Nadu","Chennai"],["Shizuoka Cancer Center","Tomoya Yokota","日本","Shizuoka","Sunto gun"],["National Cancer Center Hospital","Yoshitaka Honma","日本","Tokyo","Tokyo"],["Hokkaido University Hospital","Yasushi Shimizu","日本","Hokkaido","Sapporo"],["National Cancer Center Hospital East","Makoto Tahara","日本","Chiba","Kashiwa"],["Kansai Medical University Hospital","Masashi Kanai","日本","Osaka","Hirakata"],["Tokyo Medical University Hospital","Hideki Tanaka","日本","Tokyo","Shinjuku"],["Aichi Cancer Center","Shigenori Kadowaki","日本","Aiti Aichi","Nagoya"],["The Cancer Institute Hospital of JFCR","Naoki Fukuda","日本","Tokyo","Tokyo"],["Seoul National University Hospital","Bhumsuk Keam","韩国","NA","Seoul"],["Severance Hospital Yonsei University Health System","Sunmin Lim","韩国","Seoul","Seoul"],["Samsung Medical Center","Myung-ju Ahn","韩国","Seoul","Seoul"],["Asan Medical Center","Sung-bae Kim","韩国","NA","Seoul"],["LKH - Universitatsklinikum der PMU Salzburg","Teresa Magnes","奥地利","Salzburg","Salzburg"],["Medical University Vienna MUV","Thorsten Fureder","奥地利","Wien","Vienna"],["Krankenhaus Oberwart","Martin Pichler","奥地利","Burgenland","Oberwart"],["Medizinische Universitatsklinik Innsbruck","Florian Kocher","奥地利","Tirol","Innsbruck"],["Landesklinikum St. Polten-Lilienfeld","Martin Wiesholzer","奥地利","Niederosterreich","St Polten"],["UZ Antwerpen","Marika Rasschaert","比利时","Vlaanderen","Edegem"],["Chu Helora Hospital La Louviere Site Jolimont","Gaetan Catala","比利时","Region Wallonne","La Louviere"],["Vitaz","Willem Lybaert","比利时","Vlaams Gewest","Sint Niklaas"],["Universitair Ziekenhuis Leuven","Paul Clement","比利时","Vlaams Gewest","Leuven"],["Cliniques Universitaires Saint Luc","Jean-pascal Machiels","比利时","BRUSSEL","Brussel"],["University Hospital Ostrava","Jana Jackaninova","捷克","Moravskoslezsky kraj","Ostrava"],["Krajska nemocnice T. Bati, a.s.","Marketa Pospiskova","捷克","Zlinsky kraj","Zlin"],["Fakultni nemocnice Hradec Kralove","Milan Vosmik","捷克","Kralovehradecky kraj","Hradec Kralove"],["Fakultni nemocnice Kralovske Vinohrady","Katerina Lickova","捷克","Hlavni mesto Praha","Praha"],["Motol University Hospital","Michaela Jirkovska","捷克","Hlavni mesto Praha","Praha"],["University Hospital Olomouc","Bohuslav Melichar","捷克","Olomoucky kraj","Olomouc"],["ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS","Xavier Barthere","法国","IDF","Paris"],["Assistance PubliqueHopitaux de Marseille (AP-HM) - Hopital","Sebastien Salas","法国","Provence Alpes Cote d'Azur","Marseille"],["Centre Henri Becquerel","Florian Clatot","法国","Normandie","Rouen"],["Institut Gustave Roussy","Caroline Even","法国","NA","VILLEJUIF"],["Institut Curie","Edith Borcoman","法国","IDF","Paris"],["Clinique Victor Hugo","Cedrik Lafond","法国","Pays de la Loire","Le Mans"],["Institut Sainte Catherine","Benoit Calderon","法国","NA","Avignon Cedex 9"],["Centre Oscar Lambret","Cyril Abdeddaim","法国","Hauts de France","Lille"],["I.C.O. Rene Gauducheau","Frederic Rolland","法国","NA","Saint Herblain Cedex"],["Universitaetsklinikum Essen","Michael Pogorzelski","德国","NRW","Essen"],["Universitatsmedizin Rostock Zentrum für Innere MedizinKlinik III","Ulrich Langenkamp","德国","Mecklenburg- Western Pomerania","Rostock"],["Universitaetsklinikum Leipzig","Andreas Dietz","德国","SN","Leipzig"],["Universitatsklinikum Bonn","Peter Brossart","德国","NRW","Bonn"],["Universitaetsklinikum Regensburg","Florian Lueke","德国","BY","Regensburg"],["Universitaetsklinikum Ulm","Simon Laban","德国","BW","Ulm"],["Universitaetsklinikum Frankfurt","Christian Brandts","德国","HE","Frankfurt"],["Universitaetsklinikum Giessen und Marburg GmbH","Christine Langer","德国","HE","Giessen"],["Klinikum Region Hannover Klinikum Siloah","Martin Müller","德国","NA","Hannover"],["Debreceni Egyetem Klinikai Kozpont","Péter árkosy","匈牙利","NA","Debrecen"],["Semmelweis Egyetem","Laszlo Tamas","匈牙利","NA","Budapest"],["Szent Lazar Megyei Korhaz","Balint Tamaskovics","匈牙利","NA","Salgotarjan"],["Pecsi Tudomanyegyetem Klinikai Kozpont","Szabolcs Bellyei","匈牙利","Baranya","Pécs"],["Orszagos Onkologiai Intezet","Erika Hitre","匈牙利","Budapest","Budapest"],["Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz","Andras Szigeti","匈牙利","NA","Gyor"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Lisa Licitra","意大利","Lombardia","Milano"],["AOU Policlinico Umberto I","Alessio Cirillo","意大利","NA","Roma"],["IRCCS Policlinico San Matteo, Università degli studi di Pavi","Ilaria Imarisio","意大利","Lombardia","Pavia"],["Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone","Gaetana Rinaldi","意大利","Sicilia","Palermo"],["European Institute of Oncology","Franco Nole","意大利","Lombardia","Milano"],["Istituto Clinico Humanitas","Paolo Bossi","意大利","Milano","Rozzano"],["Fondazione G Pascale Istituto Nazionale Tumori IRCCS","Francesco Perri","意大利","Campania","Napoli"],["Universitair Medisch Centrum Groningen","Sjoukje Oosting","荷兰","GR","Groningen"],["Amsterdam UMC Cancer Center Amsterdam location VUmc","Jens Voortman","荷兰","NH","Amsterdam"],["Maastricht UMC","Lars Steggink","荷兰","LI","Maastricht"],["Uniwersyteckie Centrum Kliniczne","Ewa Pawlowska","波兰","NA","Gdansk"],["Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach","Tomasz Rutkowski","波兰","Wojewodztwo Slaskie","Gliwice"],["Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli","Izabela Kordzinska-cisek","波兰","NA","Lublin"],["Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi","Maja Lisik-habib","波兰","NA","Lodz"],["Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie","Zuzanna Synowiec","波兰","NA","Poznan"],["Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy","Andrzej Kawecki","波兰","NA","Warszawa"],["HOSP. CUF DESCOBERTAS","Diogo Alpuim Costa","葡萄牙","Lisboa","Lisboa"],["Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio","Ana Gomes","葡萄牙","Faro","Portimao"],["Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE","Maria Margarida Teixeira","葡萄牙","Coimbra","Coimbra"],["ULS GAIA ESPINHO","Ana Raquel Monteiro","葡萄牙","Porto","Vila Nova de Gaia"],["ULS SANTA MARIA - HOSP. SANTA MARIA","Leonor Abreu Ribeiro","葡萄牙","Lisboa","Lisboa"],["Instituto Portugues de Oncologia","Claudia Vieira","葡萄牙","Porto","Porto"],["Oncocenter Oncologie Clinica SRL","Roxana Scheusan","罗马尼亚","TM","Timisoara"],["Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca","Tudor Eliade Ciuleanu","罗马尼亚","Cluj","Cluj-Napoca"],["Spitalul Clinic Coltea","Ileana Raluca Patru","罗马尼亚","Bucuresti","Bucuresti"],["Clinica de Oncologie Sf Nectarie","Michael Schenker","罗马尼亚","DJ","Craiova"],["Cardiomed","Calin Ioan Cainap","罗马尼亚","CJ","Cluj Napoca"],["Institutul Regional de Oncologie Iasi","Vlad Adrian Afrasanie","罗马尼亚","Iasi","Iasi"],["HOSP UNIV VALL D HEBRON","Irene Brana","西班牙","Barcelona","Barcelona"],["HOSP. CLINICO UNIV. DE SANTIAGO","Santiago Aguin Losada","西班牙","A Coruna","Santiago de Compostela"],["HOSP. GRAL. UNIV. VALENCIA","Alfonso Berrocal","西班牙","VC","Valencia"],["HOSPITAL CLINICO SAN CARLOS","Santiago Cabezas","西班牙","MD","Madrid"],["HOSP. UNIV. 12 DE OCTUBRE","Lara Iglesias","西班牙","MD","Madrid"],["COMPLEJO HOSP DE NAVARRA - HOSP DE NAVARRA","Irene Hernandez Garcia","西班牙","NC","Pamplona"],["HOSP. GRAL. UNIV. GREGORIO MARANON","Yolanda Escobar","西班牙","MD","Madrid"],["INST. CAT. DONCOLOGIA-H DURAN I REYNALS","Zara Vidales","西班牙","CT","L'Hospitalet de Llobregat"],["HOSP. UNIV. MIGUEL SERVET","Javier Martinez Trufero","西班牙","AR","Zaragoza"],["Royal Surrey County Hospital NHS Trust","Katie Wood","英国","England","Guildford"],["Addenbrooke's Hospital","William Ince","英国","England","Cambridge"],["Royal Marsden Hospital","Kevin Harrington","英国","England","London"],["Mount Vernon Cancer Centre","Ashitha Ashraf","英国","England","Northwood"],["The Clatterbridge Cancer Centre","Anoop Haridass","英国","England","Wirral"],["Castle Hill Hospital","Louise Karsera","英国","England","Cottingham"],["Royal Marsden Hospital","Kevin Harrington","英国","England","Sutton"],["Guy's and St Thomas' NHS Foundation Trust","Delali Adjogatse","英国","England","Greater London"],["Nottingham City Hospital","Judith Christian","英国","England","Nottingham"],["Western General Hospital","David Noble","英国","Scotland","Edinburgh"],["St Bartholomew's Hospital","Pablo Nenclares","英国","England","London"],["Irmandade da Santa Casa de Misericordia de Porto Alegre","Katsuki Tiscoski","巴西","RS","Porto Alegre"],["Fundacao Doutor Amaral Carvalho","Brigida Ranzani","巴西","SP","Jau"],["Hospital Alemao Oswaldo Cruz","Cheng Yen","巴西","SP","Sao Paulo"],["Liga Norte Riograndense Contra O Cancer","Andrea Juliana Pereira De Santana Gomes","巴西","RN","Natal"],["Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia","Glaucio Antonio Bertollo","巴西","ES","Vitoria"],["FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO - CENTRO INTEGRADO DE PESQUISA","Luiza Ferreira","巴西","SP","Sao Jose do Rio Preto"],["Cuidados Oncologicos","Juan Pablo Feregrino","墨西哥","Queretaro","Queretaro"],["Centro Oncologico de Chihuahua","Marcelino Gonzalez Pinedo","墨西哥","Chihuahua","Chihuahua"],["GEFARMA S A P I DE C V ATRYS","Eduardo Cardenas Cardenas","墨西哥","CDMX","Ciudad de Mexico"],["Find My Cancer Centro de investigacion clinica","Jennifer Vanessa Ramirez Puente","墨西哥","BC","Tijuana"],["Productos y Servicios Oncologicos Acacias S A de C V","Abdel Karim Dip Borunda","墨西哥","CDMX","Ciudad de Mexico"],["Actualidad Basada En La Investigacion Del Cancer","Emmanuel De La Mora Jimenez","墨西哥","Jal","Guadalajara"],["NHO Revive Research Institute, LLC","Kailash Mosalpuria","美国","NE","Lincoln"],["MD Anderson Cancer Center","Renata Ferrarotto","美国","TX","Houston"],["AdventHealth Medical Group Oncology and Hematology at Orlando","Tarek Mekhail","美国","FL","Orlando"],["Vanderbilt University Medical Center","Jennifer Choe","美国","TN","Nashville"],["Florida Cancer Specialists North Region","Pareshkumar Patel","美国","FL","Saint Petersburg"],["Montefiore Medical Center","Enrico Castellucci","美国","NY","Bronx"],["Trinity Health St Joseph Mercy Ann Arbor","Tareq Al Baghdadi","美国","MI","Ann Arbor"],["Karmanos Cancer Institute","Ammar Sukari","美国","MI","Detroit"],["Central Georgina Cancer Care","Bradley Sumrall","美国","GA","Macon"],["Ellis Hospital","Tallat Mahmood","美国","NY","Schenectady"],["University of Arizona Cancer Center","Ricklie Julian","美国","AZ","Tucson"],["Oregon Health And Science University","Chetan Vakkalagadda","美国","OR","Portland"],["Hartford HealthCare Cancer Institute at Hartford Hospital","Tony Hung","美国","CT","Hartford"],["Florida Cancer Specialists South","Amir Harandi","美国","FL","Fort Myers"],["Bronx Veterans Affairs Medical Center","Anna Park","美国","NY","Bronx"],["Rutgers New Jersey Medical School","Missak Haigentz","美国","NJ","Newark"],["Ohio State University","Priyanka Bhateja","美国","OH","Columbus"],["Tennessee Cancer Specialists","Tracy Dobbs","美国","TN","Knoxville"],["University of Pennsylvania Perelman Center for Advanced Medicine","Lee Hartner","美国","PA","Philadelphia"],["Oncology and Hematology Associates of Southwest Virginia, Inc.","Jerome Goldschmidt","美国","VA","Blacksburg"],["Ironwood Cancer and Research Center","Rajesh Kukunoor","美国","AZ","Chandler"],["Florida Cancer Specialists East","Augusto Villegas","美国","FL","West Palm Beach"],["Emory University","Nabil Saba","美国","GA","Atlanta"],["The University of Chicago Medical Center (UCMC)","Noura Choudhury","美国","IL","Chicago"],["Valkyrie Clinical Trials","David Berz","美国","CA","Los Angeles"],["Stanford University Medical Center","Saad Khan","美国","CA","Stanford"],["University of Cincinnati College of Medicine","Trisha Wise-draper","美国","OH","Cincinnati"],["George Washington University","Julie Bauman","美国","DC","Washington"],["Texas Oncology - San Antonio Medical Center","Alyssa Rieber","美国","TX","Fredericksburg"],["Cancer Care Specialists of Central Illinois","James Wade","美国","IL","O'Fallon"],["University of Virginia","Varinder Kaur","美国","VA","Charlottesville"],["Dana Farber Cancer Institute","Robert Haddad","美国","MA","Boston"],["University of California, Los Angeles UCLA","Deborah Wong","美国","CA","Los Angeles"],["Rush University Medical Center Rush University Cancer Center Chicago","Michael Jelinek","美国","IL","Chicago"],["Regional Medical Oncology Center","Keith Lerro","美国","NC","Wilson"],["University of Marlyand Baltimore","Ranee Mehra","美国","MD","Baltimore"],["Washington University School Of Medicine","Douglas Adkins","美国","MO","St. Louis"],["Virginia Cancer Specialists","Alexander Spira","美国","VA","Arlington"],["Providence Medical Foundation","Yung Lyou","美国","CA","Fullerton"],["Yale Cancer Center","Barbara Burtness","美国","CT","New Haven"],["Texas Oncology-Central South","Carl Chakmakjian","美国","TX","Waco"],["Huntsman Cancer Institute","Kathleen Kerrigan","美国","UT","Salt Lake City"],["UCSF Medical Center at Mission Bay","Alain Algazi","美国","CA","San Francisco"],["University of Kentucky Medical Center","Ralph Zinner","美国","KY","Lexington"],["University of Miami Sylvester Comprehensive Cancer Center","Coral Olazagasti","美国","FL","Miami"],["NYU Langone Medical Center","Zujun Li","美国","NY","New York"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市东方医院药物/器械临床试验伦理委员会","同意","2025-09-09"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 75 ； 国际: 500 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；