上海注射用戈沙妥珠单抗III期临床试验-在含铂化疗和免疫疗法经治的子宫内膜癌受试者中比较戈沙妥珠单抗与医生选择治疗的研究

登记号	CTR20244107	试验状态	进行中
申请人联系人	张丽	首次公示信息日期	2024-11-01
申请人名称	Gilead Sciences, Inc./ 吉利德（上海）医药科技有限公司/ BSP Pharmaceuticals S.p.A.

登记号	CTR20244107
相关登记号	暂无
药物名称	注射用戈沙妥珠单抗
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	复发性或晚期子宫内膜癌
试验专业题目	一项在既往接受过含铂化疗和抗PD-1/PD-L1免疫疗法的子宫内膜癌受试者中比较戈沙妥珠单抗与医生选择治疗的随机、开放、III 期研究
试验通俗题目	在含铂化疗和免疫疗法经治的子宫内膜癌受试者中比较戈沙妥珠单抗与医生选择治疗的研究
试验方案编号	GS-US-682-6769	方案最新版本号	修正案1
版本日期:	2024-05-15	方案是否为联合用药	否

申请人名称	[["Gilead Sciences, Inc."],["吉利德（上海）医药科技有限公司"],["BSP Pharmaceuticals S.p.A."]]
联系人姓名	张丽	联系人座机	010-58845640	联系人手机号
联系人Email	Li.Zhang26@gilead.com	联系人邮政地址	上海市-上海市-中国（上海）自由贸易试验区世纪大道1198号31层	联系人邮编	200122

主要目的： 1. 比较SG 与TPC 对BICR 评估的PFS 的影响； 2. 比较SG 与TPC 对OS的影响 关键次要目的： 1． 比较SG 与TPC 对BICR 评估的ORR 的影响； 2． 比较SG 与TPC 对躯体功能的影响 次要目的： 1. 比较SG 与TPC 对下列各项指标的影响： 研究者评估的PFS 研究者评估的ORR BICR 和研究者评估的DOR BICR 和研究者评估的CBR 2. 评价SG 相比TPC 的安全性和耐受性 3. 比较SG 与TPC 对GHS/QoL 产生的影响 探索性目的： 1． 评估肿瘤的滋养层细胞表面抗原2（Trop-2）表达状态，作为SG疗效的潜在预测性生物标记物 2． 评估肿瘤MMR/MSI 状态和临床缓解或治疗耐药之间的关系 3． 探索可预测临床缓解或治疗耐药的血液和肿瘤生物标志物 4． 表征SG 的药代动力学（PK）和免疫原性 5． 进一步表征健康相关QoL

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	女
健康受试者	无
入选标准	[["有记录证实受试者患有复发性/晚期子宫内膜癌（子宫内膜样癌或癌肉瘤）。"],["既往最多接受过3线子宫内膜癌全身治疗，包括全身含铂化疗和抗PD-1/PD-L1治疗（联合治疗或顺序治疗）。"],["研究者确认受试者有资格接受多柔比星或紫杉醇治疗。"],["研究者根据RECIST v1.1标准评估，受试者存在计算机断层扫描（CT）或磁共振成像（MRI）显示的影像学可评价病灶（可测量或不可测量）。"],["美国东部肿瘤协作组体能状态评分为0或1。"],["合适的器官功能"]]
排除标准	[["子宫平滑肌肉瘤和子宫内膜间质肉瘤患者不得入组"],["受试者在研究入组时适合接受根治性治疗。"],["研究者认为受试者有资格再次接受含铂化疗。"],["受试者既往接受过任何靶向Trop-2的抗体偶联药物（ADC）治疗。"],["受试者患有活动性第二恶性肿瘤。"],["受试者患有需要全身抗感染治疗的活动性严重感染。"],["在随机化前6个月内患有活动性慢性炎症性肠病（溃疡性结肠炎、克罗恩病）或胃肠穿孔。"],["生理性别为女性的受试者血清妊娠试验呈阳性或处于哺乳期。"]]

试验药	[["中文通用名:注射用戈沙妥珠单抗 英文通用名:SacituzumabGovitecan 商品名称:拓达维®","剂型:注射剂 规格:180mg/瓶 用法用量:10mg/kg,静脉输注 用药时程:在21周期的第1天和第8天给药"]] 序号 名称 用法
对照药	[["中文通用名:注射用盐酸多柔比星 英文通用名:DoxorubicinHydrochlorideforInjection 商品名称:NA","剂型:注射剂 规格:10mg/瓶 用法用量:60mg/m2,静脉输注 用药时程:在21天周期的第1天进行静脉给药"],["中文通用名:紫杉醇注射液 英文通用名:PaclitaxelInjection 商品名称:特素","剂型:注射剂 规格:16.7ml,100mg/瓶 用法用量:80mg/m2,静脉输注 用药时程:在28天周期的第1、8、15天进行静脉给药"]] 序号 名称 用法

主要终点指标及评价时间

[["PFS，定义为从随机化日期至经BICR 根据实体瘤疗效评价标准第1.1 版（RECIST v1.1）评估的客观疾病进展（PD）或全因死亡（以先发生者为准）的时间","最多27个月","有效性指标"],["OS， 定义为从随机化日期至全因死亡的时间","最多47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

[["ORR， 定义为基于BICR 根据ECIST v1.1 标准评估，首次记录缓解后相隔≥4 周确认的最佳总体缓解为完全缓解（CR）或部分缓解（PR）的受试者百分比","最多47个月","有效性指标"],["第13 周时，采用欧洲癌症研究与治疗组织生活质量问卷-核心问卷30 第3.0 版（EORTC QLQ-C30）评估的躯体功能评分较基线的变化","基线，第13周","有效性指标+安全性指标"],["PFS， 定义为从随机化日期至由研究者根据RECIST v1.1 标准评估的客观PD 或全因死亡（以先发生者为准）的时间","最多27个月","有效性指标"],["ORR ，定义为基于研究者根据RECIST v1.1 标准评估，首次记录缓解后相隔≥4 周确认的最佳总体缓解为CR 或PR 的受试者百分比","最多47个月","有效性指标"],["DOR，定义为基于BICR 和研究者根据RECIST v1.1 标准评估，从首次记录CR 或PR 至首次记录明确PD或全因死亡（以先发生者为准）的时间","最多47个月","有效性指标"],["CBR，为基于BICR 和研究者根据RECIST1.1 评估，首次记录缓解后相隔≥4 周确认的最佳总体缓解为CR 或PR，或达到持久的SD（从随机化至疾病进展的SD 持续时间≥6 个月）的受试者百分比","最多47个月","有效性指标"],["治疗期间出现的不良事件（TEAE）和临床实验室检查异常的发生率","首次给药日期至末次给药后30天（最多47个月）","安全性指标"],["第13 周时，采用EORTC QLQ-C30 评估的GHS/QoL 评分较基线的变化","基线，第13周","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	吴小华	学位	博士	职称	主任医师、教授、博士研究生导师
	电话	13601772486	Email	Wu.xh@fudan.edu.cn	邮政地址	上海市-上海市-上海市徐汇区东安路270号
	邮编	200032	单位名称	复旦大学附属肿瘤医院

[["复旦大学附属肿瘤医院","吴小华","中国","上海市","上海市"],["北京肿瘤医院","郑虹","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","高庆蕾","中国","湖北省","武汉市"],["重庆大学附属肿瘤医院","周琦","中国","重庆市","重庆市"],["浙江大学医学院附属妇产科医院","沈源明","中国","浙江省","杭州市"],["上海市第十人民医院","陈晓军","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","杨勤","中国","湖北省","武汉市"],["中山大学孙逸仙纪念医院","周晖","中国","广东省","广州市"],["河南省肿瘤医院","王莉","中国","河南省","郑州市"],["吉林大学第一医院","张松灵","中国","吉林省","长春市"],["湖南省肿瘤医院","唐洁","中国","湖南省","长沙市"],["四川大学华西第二医院","尹如铁","中国","四川省","成都市"],["天津市肿瘤医院（天津医科大学肿瘤医院）","王珂","中国","天津市","天津市"],["广西医科大学附属肿瘤医院","姚德生","中国","广西壮族自治区","南宁市"],["西安交通大学医学院第一附属医院","安瑞芳","中国","陕西省","西安市"],["浙江省肿瘤医院","朱滔","中国","浙江省","杭州市"],["哈尔滨医科大学附属肿瘤医院","娄阁","中国","黑龙江省","哈尔滨市"],["江西省妇幼保健院","曾四元","中国","江西省","南昌市"],["Queen Mary Hospital","Ka Yu Tse","中国香港","香港","香港"],["Prince of Wales Hospital","Winnie Yeo","中国香港","香港","香港"],["Hong Kong Sanatorium & Hospital","Amy Tien Yee Chang","中国香港","香港","香港"],["Mackay Memorial Hospital","Chih-Long Chang","中国台湾","台湾","台湾"],["Taichung Veterans General Hospital","Chien-Hsing Lu","中国台湾","台湾","台湾"],["Kaohsiung Veterans General Hospital","Wen-Shiung Liou","中国台湾","台湾","台湾"],["Chang Gung Memorial Hospital (CGMH)","Chyong-Huey Lai","中国台湾","台湾","台湾"],["National Taiwan University Hospital","Lin-Hung Wei","中国台湾","台湾","台湾"],["National Cheng Kung University Hospital","Yu-Fang Huang","中国台湾","台湾","台湾"],["Mater Cancer Care Centre","Catherine Shannon","澳大利亚","澳大利亚","South Brisbane"],["Peter MacCallum Cancer Centre","Linda Mileshkin","澳大利亚","澳大利亚","Melbourne"],["Sir Charles Gairdner Hospital","Tarek Meniawy","澳大利亚","澳大利亚","Murdoch"],["Monash Health","Kate Webber","澳大利亚","澳大利亚","Clayton"],["Chris O'Brien Lifehouse","Michelle Harrison","澳大利亚","澳大利亚","Camperdown"],["A Beneficência Portuguesa de S？o Paulo - Unidade Mirante","Graziela Dal Molin","巴西","巴西","S？o Paulo"],["Instituto Nacional de Cancer","Andreia Cristina de Melo","巴西","巴西","Rio de Janeiro"],["Hospital Nove de Julho","Mariana Scaranti","巴西","巴西","S？o Paulo"],["Instituto Santa Joana Recife de Ensino e Pesquisa","Andrea Lopes Ponte de Souza","巴西","巴西","Recife"],["Associa？？o Hospitalar Moinhos de Vento","Jose Roberto Freitas Rossari","巴西","巴西","Porto Alegre"],["Ensino e Terapia de Inova？？o Clínica AMO-ETICA","Aknar Freire de Carvalho Calabrich","巴西","巴西","Salvador"],["Funda？？o Antonio Prudente - Hospital do Cancer AC Camargo","Elizabeth Santana dos Santos","巴西","巴西","S？o Paulo"],["Canberra Hospital","Alison Davis","澳大利亚","澳大利亚","Canberra"],["Instituto do Cancer do Estado de S？o Paulo","Vanessa da Costa Miranda","巴西","巴西","S？o Paulo"],["Catarina Pesquisa Clinica (Centro Novos Tratamentos Itajai)","Giuliano Borges","巴西","巴西","Itajai"],["Instituto D'Or de Pesquisa e Ensino - RJ","Eduardo Paulino","巴西","巴西","Rio de Janeiro"],["McGill University Health Centre","Xing Zeng","加拿大","加拿大","Montreal"],["Sunnybrook Health Sciences Centre","Lilian Given","加拿大","加拿大","Toronto"],["Princess Margaret Cancer Centre","Amit Oza","加拿大","加拿大","Toronto"],["Tom Baker Cancer Center","Prafull Ghatage","加拿大","加拿大","Calgary"],["CHU de Québec-Université Laval’s H？pital Hotel-Dieu","Vincent Castonguay","加拿大","加拿大","Quebec"],["London Health Sciences Centre","Ana Lohmann","加拿大v","加拿大","London"],["General University Hospital in Prague","David Cibula","捷克共和国","捷克共和国","Prague"],["Bulovka University Hospital, Institute of Radiation Oncology","Michal Zikan","捷克共和国","捷克共和国","Prague"],["Nemocnice AGEL, Novy Ji？ín a.s.","Vojtěch Tlusty","捷克共和国","捷克共和国","Novy Ji？ín"],["Centre Antoine Lacassagne","Philippe Follana","法国","法国","法国"],["Institut Paoli Calmettes","Renaud Sabatier","法国","法国","法国"],["Centre Francois Baclesse","Florence Joly","法国","法国","法国"],["Ico René Gauducheau","Jean-Sebastien Frenel","法国","法国","Saint-Herblain"],["Institut Gustave Roussy","Alexandra Leary","法国","法国","villejuif"],["H？pital Cochin","Jér？me Alexandre","法国","法国","法国"],["Universit？tsklinikum Hamburg","Linn W？lber","德国","德国","Hamburg"],["Medical School Hannover","Tjoung-Won Park-Simon","德国","德国","Hannover"],["Universit？tsklinikum Düsseldorf","Tanja Fehm","德国","德国","Düsseldorf"],["Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde","Holger Bronger","德国","德国","München"],["Universit？tsklinikum Ulm - Klinik für Frauenheilkunde und Geburtshilfe","Sabine Heublein","德国","德国","Ulm"],["Universit？tsklinikum Mannheim","Frederik Marme","德国","德国","Mannheim"],["Hochtaunus Kliniken Bad Homburg","Dominik Denschlag","德国","德国","Bad Homburg"],["University Hospital Essen","Pawel Mach","德国","德国","Essen"],["University Hospital Leipzig","Bahriye Aktas","德国","德国","Leipzig"],["General Hospital of Patras Agios Andreas","Athina Christopoulou","希腊","希腊","希腊"],["Saint Luke's University Hospital","Eleni Fountzilas","希腊","希腊","希腊"],["MITERA hospital","Manto Nikolaidi","希腊","希腊","希腊"],["KALAMATA HOSPITAL","Sofia Stamatopoulou","希腊","希腊","希腊"],["Aretaeion Hospital","Flora Zagouri","希腊","希腊","希腊"],["Sheba Medical Center","Jacob Korach","以色列","以色列","ramat GAn"],["Hillel Yaffe Medical Center","Ilan Bruchim","以色列","以色列","Hadera"],["Hadassah Medical Center","Jonathan Cohen","以色列","以色列","Jerusalem"],["Rambam Health Care Campus","Revital Linder","以色列","以色列","HAIFA"],["Sourasky T.A.M.C.","Tamar Safra","以色列","以色列","Tel Aviv-Yaffo"],["Wolfson Medical Center","Tally Levy","以色列","以色列","Holon"],["Policlinico Universitario Argostino Gemelli","Vanda Salutari","意大利","意大利","Roma"],["Division of Medical Oncology 1St. Chiara University Hospital, Pisa","Carmelo Bengala","意大利","意大利","Pisa"],["Ospedale San Raffaele","Alice Bergamini","意大利","意大利","Milan"],["Istituto Europeo di Oncologia","Nicoletta Colombo","意大利","意大利","Milan"],["ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco","Federica Villa","意大利","意大利","Lecco"],["A.O. Ordine Mauriziano di Torino - Ospedale Umberto I","Giorgio Valabrega","意大利","意大利","Torino"],["Centro di Riferimento Oncologico di Aviano","Michele Bartoletti","意大利","意大利","Aviano"],["AOU Careggi-Oncologia Medica Ginecologica","Maria Cristina Petrella","意大利","意大利","Firenze"],["Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori – IRST","Alberto Farolfi","意大利","意大利","Meldola"],["Istituto Regina Elena","Antonella Savarese","意大利","意大利","Rome"],["AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna","Elisa Piovano","意大利","意大利","Torino"],["Istituto Oncologico Veneto IRCCS","Valentina Guarneri","意大利","意大利","Padova"],["The Cancer Institute Hospital of JFCR","Mayu Yunokawa","日本","日本","Tokyo"],["The Jikei University Kashiwa Hospital","Hirokuni Takano","日本","日本","Chiba"],["Okayama University Hospital","Shoji Nagao","日本","日本","Okayama"],["St. Marianna University Hospital","Nao Suzuki","日本","日本","Kanagawa"],["National Cancer Center Hospital","Kan Yonemori","日本","日本","Tokyo"],["Hyogo Cancer Center","Kasumi Yamamoto","日本","日本日本","Hyogo"],["Shizuoka Cancer Center","Atsuko Kawamura","日本","日本","Shizuoka"],["Saitama Medical University International Medical Center","Kosei Hasegawa","日本","日本","Saitama"],["Szpitale Pomorskie Sp. z o.o.","Joanna Pikiel","波兰","波兰","Gdynia"],["Dolnoslaskie Centrum Onkologii","Bozena","波兰","波兰","Wroclaw"],["Szamodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie","Marcin","波兰","波兰","Lublin"],["Mazowiecki Szpital Wojewódzki im. ？w. Jana Paw？a II w Siedlcach","Lubomir","波兰","波兰","Siedlce"],["National University Hospital","David Shao Peng Tan","新加坡","新加坡","新加坡"],["Samsung Medical Center","Byoung-Gie Kim Jae-Weon Kim","韩国","韩国","Seoul"],["Seoul National University Hospital","Jae-Weon Kim","韩国","韩国","Seoul"],["Severance Hospital","Jung-Yun Lee","韩国","韩国","Seoul"],["Asan Medical Center","Jeong-Yeol Park","韩国","韩国","Seoul"],["Keimyung University Dongsan Medical Center","So Jin Shin","韩国","韩国","Dalseo-gu, Daegu"],["National Cancer Center - Korea","Myong Cheol Lim","韩国","韩国","Goyang-si"],["Hospital Universitario La Fe - Valencia","Ana Maria Santaballa Bertran","西班牙","西班牙","VALENCIA"],["Hospital Universitario de Jaen","Fernando Galvez Montosa","西班牙","西班牙","Jaén"],["Hospital Universitario Ramón y Cajal","Eva Maria Guerra Alia","西班牙","西班牙","MADRID"],["Complexo Hospitalario Universitario A Coruna (CHUAC)","Maria Quindos Varela","西班牙","西班牙","A Coru？a"],["Hospital Clinic de Barcelona","Lydia Gaba","西班牙","西班牙","Barcelona"],["Hospital General Universitario Gregorio Maranon","Sara Perez Ramirez","西班牙","西班牙","Madrid"],["Hospital Parc Taulí","Pablo Andreu Cobo","西班牙","西班牙","Sabadell"],["Hospital Universitario Virgen de la Victoria","MARíA JOSé BERMEJO PéREZ","西班牙","西班牙","MáLAGA"],["Hospital Clinico San Carlos","Gloria Marquina","西班牙","西班牙","Madrid"],["St James’ University Hospital, Leeds Teaching Hospitals Trust","David Jackson","英国","英国","Leeds"],["University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary","Joanna Wood","英国","英国","Leicester"],["East and North Hertfordshire NHS Trust","Saira Khalique","英国","英国","Northwood"],["UCL Hospitals NHS Foundation Trust","Gemma Eminowicz","英国","英国","London"],["Cambridge University Hospitals NHS Foundation Trust","Christine Parkinson","英国","英国","Cambridge"],["Florida Cancer Specialists MAIN","Elizabeth Guancial","美国","美国","Fort Meyers"],["Hartford Hospital","Amanda Ramos","美国","美国","Hartford"],["MD Anderson Cancer Center","Shannon Westin","美国","美国","Houston"],["University of Nebraska","Lindsey McAlarnen","美国","美国","Omaha"],["Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa","Michael Gold","美国","美国","Tulsa"],["UC San Diego Medical Center","Ramez Eskander","美国","美国","La Jolla"],["University of Colorado Cancer Center","Bradley Corr","美国","美国","Aurora"],["Yale University School of Medicine","Alessandro Santin","美国","美国","New Haven"],["SUNY Upstate Medical Center","Mary Cunningham","美国","美国","Syracuse"],["Tufts Medical Center","Rafael Gonzalez","美国","美国","Miami"],["University of Minnesota","Britt Erickson","美国","美国","Minneapolis"],["Columbia University Medical Center","Jason Wright","美国","美国","New York"],["Mayo Clinic Jacksonville","Gerardo Colon-Otero","美国","美国","Jacksonville"],["Baylor College of Medicine","Jan Sunde","美国","美国","Houston"],["West Michigan Cancer Center","Anna Hoekstra","美国","美国","Kalamazoo"],["Massachusetts General Hospital","Oladapo Yeku","美国","美国","Boston"],["University of Arkansas for Medical Sciences","Heather Williams","美国","美国","Little Rock"],["Oschner Medical Foundation","Katrina Wade","美国","美国","New Orleans"],["UT Southwesten Medical Center","Jayanthi Lea","美国","美国","Dallas"],["University of South Florida","Matthew Anderson","美国","美国","Tampa"],["Northwell Health","Veena John","美国","美国","Lake Success"],["Baystate Medical Center Inc.","Tashana Myers","美国","美国","Springfield"],["Roswell Park Cancer Institute","Katherine Mager","美国","美国","Buffalo"],["Cleveland Clinic - Taussig Cancer Institute","Roberto Vargas","美国","美国","Cleveland"],["MUSC Health Hematology Oncology at Hollings Cancer Center","Whitney Graybill","美国","美国","Charleston"],["Norton Cancer Institute","Justin Gorski","美国","美国","Louisville"],["Medical College of Wisconsin","Elizabeth Hopp","美国","美国","Milwaukee"],["Fred Hutchinson Cancer Research Center","Kalyan Banda","美国","美国","Seattle"],["Women's Cancer Care","Patricia Braly","美国","美国","Covington"],["University of Chicago","Katherine Kurnit","美国","美国","Chicago"],["City of Hope","Joshua Cohen","美国","美国","Irvine"],["University of Florida","Merry Markham","美国","美国","Gainesville"],["Baptist Health Lexington","Hope Cottrill","美国","美国","Lexington"],["Wilmot Cancer Institute - University of Rochester","Rachael Turner","美国","美国","Rochester"],["Northwestern University Feinberg School of Medicine","Jenna Marcus","美国","美国","Chicago"],["University of Pennsylvania","Sarah Kim","美国","美国","Philadelphia"],["Greater Baltimore Medical Center","Kimberly Levinson","美国","美国","Baltimore"],["Stanford University","Emily McClung","美国","美国","Palo Alto"],["University of Mississippi Medical Center","Rodney Rocconi","美国","美国","Jackson"],["Atrium Health Wake Forest Baptist","Janelle Pakish Darby","美国","美国","Winston-Salem"],["Memorial Sloan-Kettering Cancer Center","Vicky Makker","美国","美国","New York City"],["University of Virginia","Marilyn Huang","美国","美国","Charlottesville"],["Cedars Sinai Medical Center","Bobbie Rimel","美国","美国","Los Angeles"],["Rutgers Cancer Institute of New Jersey","Aliza Leiser","美国","美国","New Brunswick"],["Alliance Cancer Specialists","Mark Shahin","美国","美国","Horsham"],["Emory University","Susan Modesitt","美国","美国","Altanta"],["Baptist MD Anderson Cancer Center","Lauren Hand","美国","美国","Jacksonville"],["SCRI Oncology Partners","Erika Hamilton","美国","美国","Nashville"],["Texas Oncology","Noelle Cloven","美国","美国","Forth Worth"],["MMCORC","Adrianne Mallen","美国","美国","St Louis Park"],["Virginia Oncology Associates","Michael McCollum","美国","美国","Norfolk"],["University of New Mexico","Carolyn Muller","美国","美国","Albuquerque"],["Indiana University Health Melvin and Bren Simon Cancer Center","Lisa Landrum","美国","美国","Indianapolis"],["University of Wisconsin","Janelle Sobecki","美国","美国","Madison"],["MidAmerica Division, Inc. c/o Research Medical Center","K. Shawn LyBarger","美国","美国","Kansas City"],["Nancy N. and J.C. Lewis Cancer and Research Pavilion","Sarah Gill","美国","美国","Savannah"],["Ohio Health Research Institute","Aine Clements Juraj Kavecansky","美国","美国","Columbus"],["Kaiser Permanente Oncology Clinical Trials","Juraj Kavecansky","美国","美国","Vallejo"],["Providence Cancer Institute Franz Clinic","Christopher Darus","美国","美国","Portland"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["复旦大学附属肿瘤医院医学伦理委员会","同意","2024-07-15"]]

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: 78 ； 国际: 520 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 3 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 3 ；

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：2024-08-28；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-09-03；
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；