上海Pasritamig注射液III期临床试验-比较Pasritamig和安慰剂作为转移性去势抵抗性前列腺癌（mCRPC）的后线治疗

登记号	CTR20254394	试验状态	进行中
申请人联系人	马浩程	首次公示信息日期	2025-11-05
申请人名称	Janssen Research & Development, LLC/ 强生（中国）投资有限公司/ Cilag AG/ Janssen Pharmaceutica NV, Division of Janssen Research and Development; Fisher Clinical Services.; Fisher Clinical Services UK Limited; Fisher Clinical Services GmbH; Thermo Fisher Scientific, Fisher Bioservices Division; Catalent Pharma Solutions, LLC; Catalent Germany Schorndorf GmbH

登记号	CTR20254394
相关登记号	暂无
药物名称	Pasritamig注射液
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	转移性去势抵抗性前列腺癌
试验专业题目	一项比较Pasritamig（JNJ-78278343；一种靶向人激肽释放酶2的T细胞重定向药物）联合最佳支持治疗和最佳支持治疗用于转移性去势抵抗性前列腺癌的III期、随机、双盲、安慰剂对照研究
试验通俗题目	比较Pasritamig和安慰剂作为转移性去势抵抗性前列腺癌（mCRPC）的后线治疗
试验方案编号	78278343PCR3001	方案最新版本号	原始版本
版本日期:	2025-04-22	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 Pharmaceutica NV, Division of Janssen Research and Development; Fisher Clinical Services.; Fisher Clinical Services UK Limited; Fisher Clinical Services GmbH; Thermo Fisher Scientific, Fisher Bioservices Division; Catalent Pharma Solutions, LLC; Catalent Germany Schorndorf GmbH"]]
联系人姓名	马浩程	联系人座机	021-33376008	联系人手机号
联系人Email	hma38@its.jnj.com	联系人邮政地址	北京市-北京市-朝阳区建国路77号19层1901室	联系人邮编	100025

本试验的目的是在转移性去势抵抗性前列腺癌（mCRPC）人群中，评估Pasritamig（JNJ-78278343）＋最佳支持治疗（BSC）与安慰剂＋BSC相比的总生存期（定义为研究开始至任何原因导致的死亡的时间）

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	双盲	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
健康受试者	无
入选标准	[["签署知情同意书时，年满18岁（或达到研究开展国家/地区认可的法定成年年龄）"],["组织学确诊为前列腺腺癌"],["mCRPC：筛选时存在骨转移和/或任何淋巴结转移，且没有明确的内脏器官转移证据。筛选时PSA≥2 ng/mL"],["筛选时PSA≥2 ng/mL"],["研究者认为临床试验是当前最合适的下一步治疗方案"],["受试者应已接受过所有研究者认为其临床适用且可以获得的延长生命的治疗。既往治疗可用于治疗任何疾病阶段（不限于mCRPC）"],["必须在研究药物首次给药前停用任何其他抗癌治疗或试验用药物至少2周"],["既往接受过睾丸切除术或药物去势（在研究治疗首次给药前正在接受促性腺激素释放激素[GnRH]类似物[激动剂或拮抗剂] ADT治疗，并且必须在整个治疗期间持续接受该治疗）"],["必须已从任何近期手术或创伤中充分恢复"],["ECOG体能状态评分为0-2分"],["肾功能、肝功能和血液学实验室检查指标均在要求范围内"],["受试者必须同意，在研究治疗期间和研究治疗末次给药后3个月内遵守以下要求：n不得捐献配子（即精子）或冷冻配子以备将来用于辅助生殖。n当可能发生精子传播/射精时，应佩戴外用避孕套。n如果受试者能够生成精子且女性伴侣有生育能力，则女性伴侣必须采取高效避孕方法"],["受试者必须签署知情同意书（ICF），表明他们理解研究的目的和所需的程序，且愿意参与本研究"],["受试者必须愿意并能够遵循研究方案规定的生活方式限制要求"]]
排除标准	[["接受过实体器官或骨髓移植"],["研究治疗首次给药前1个月内发生静脉血栓栓塞事件；单纯性（≤2级）深静脉血栓形成不满足排除标准"],["在签署知情同意书前12个月内患有需要全身性免疫抑制药物治疗的活动性自身免疫性疾病"],["研究治疗首次给药前7天内患有需要全身性抗生素治疗的活动性感染或病症"],["具有临床意义的肺损伤，尤其是需要使用吸氧（鼻氧管流速＞2 L/min）以维持充分氧合"],["疑似或已知对Pasritamig的辅料过敏、超敏或不耐受"],["受试者既往患有或并发第二种恶性肿瘤（研究疾病除外），并且其自然病程或治疗可能干扰任何研究安全性终点或研究治疗的疗效"],["研究治疗首次给药前6个月内出现心血管系统疾病"],["已知有脑或软脑膜前列腺癌转移史"],["已知HIV阳性且符合方案定义的实验室检查数值的受试者"],["活动性或慢性乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染"],["既往接受过KLK2靶向治疗"],["既往接受过任何CD3靶向治疗"],["在研究治疗首次给药前3天内接受过免疫抑制剂量的全身性药物，如糖皮质激素（剂量＞10 mg/天泼尼松或等效药物）"],["在研究治疗首次给药前4周内接种过或计划接种任何减毒活疫苗。允许最迟在研究治疗前7天接种减毒活流感疫苗"],["任何可能损害受试者在研究中心接受或耐受计划治疗、理解知情同意书能力的严重基础疾病或其他问题，或者任何由研究者认为参加研究不符合受试者最佳利益（例如，损害健康）的状况，或者任何可能会妨碍、限制或混淆研究方案规定评估的状况"]]

试验药

[["中文通用名:Pasritamig(JNJ-78278343） 英文通用名:Pasritamig(JNJ-78278343） 商品名称:NA","剂型:输注溶液 规格:NA 用法用量:研究治疗将采用逐步递增剂量的方法。递增剂量1（SU1）在第1周期第1天（C1D1）给药，递增剂量2（SU2）在C1D8给药，目标剂量在C1D15给予。从第2周期第1天（C2D1）开始，参与者将每6周（Q6W）接受Pasritamig的目标剂量 用药时程:参与者将在第1周期第1天（C1D1）接受SU1，然后在C1D8接受SU2。目标剂量将在C1D15给药。第1周期将在C1D15全剂量给药后6周结束。从第2周期第1天（C2D1）开始，参与者将每6周（Q6W）接受目标剂量，持续治疗，直到疾病进展、死亡、无法忍受的毒性、撤回同意或研究结束，以先发生者为准"]] 序号 名称 用法

对照药

[["中文通用名:安慰剂 英文通用名:MatchingPlacebo(Sodiumacetatetrihydrate,glacialaceticacid,sucrose,polysorbate20,ethylenediaminetetraaceticacid(EDTA),waterforinjection) 商品名称:NA","剂型:输注溶液 规格:NA 用法用量:安慰剂将采用逐步递增剂量的方法。递增剂量1（SU1）在第1周期第1天（C1D1）给药，递增剂量2（SU2）在C1D8，目标剂量在C1D15。从第2周期第1天（C2D1）开始，参与者将每6周（Q6W）静脉注射安慰剂 用药时程:参与者将在第1周期第1天（C1D1）接受安慰剂的SU1，随后在C1D8接受SU2。目标剂量将在C1D15给药。第1周期将在C1D15全剂量给药后6周结束。从第2周期第1天（C2D1）开始，参与者将每6周（Q6W）接受目标剂量，直到确认疾病进展、死亡、无法忍受的毒性、撤回同意或研究结束，以先发生者为准"]] 序号 名称 用法

主要终点指标及评价时间	[["总生存期","约4年8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	[["影像学无进展生存期（rPFS）","约4年8个月","有效性指标"],["至症状进展时间","约4年8个月","有效性指标"],["至骨相关事件（SRE）时间","约4年8个月","有效性指标"],["无进展生存期（PFS）","约4年8个月","有效性指标"],["至PSA进展时间","约4年8个月","有效性指标"],["至疼痛进展时间（通过BPI-SF量表第3项，即过去24小时内最严重疼痛程度评估）","约4年8个月","有效性指标"],["至乏力恶化时间（通过EORTC QLQ-C30量表评估）","约4年8个月","有效性指标"],["发生不良事件的受试者数量","约4年8个月","安全性指标"],["发生临床实验室检查异常的受试者数量","约4年8个月","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	叶定伟	学位	医学博士	职称	主任医师
	电话	021-64175590	Email	FUSCC2012@163.com	邮政地址	上海市-上海市-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","叶定伟","中国","上海市","上海市"],["西安交通大学第一附属医院","李磊","中国","陕西省","西安市"],["北京大学第一医院","范宇","中国","北京市","北京市"],["重庆大学附属肿瘤医院","刘南","中国","重庆市","重庆市"],["武汉大学中南医院","杨中华","中国","湖北省","武汉市"],["南通市肿瘤医院","王小林","中国","江苏省","南通市"],["四川大学华西医院","沈朋飞","中国","四川省","成都市"],["天津医科大学第二医院","王勇","中国","天津市","天津市"],["湖南省肿瘤医院","蒋书算","中国","湖南省","长沙市"],["温州医科大学附属第一医院","陈伟","中国","浙江省","温州市"],["南京大学医学院附属鼓楼医院","郭宏骞","中国","江苏省","南京市"],["广西医科大学第一附属医院","程继文","中国","广西壮族自治区","南宁市"],["吉林大学第一医院","刘子玲","中国","吉林省","长春市"],["中山大学肿瘤防治中心","史艳侠","中国","广东省","广州市"],["National Taiwan University Hospital","Yu-Chieh Tsai","中国台湾","台北","台北"],["Taipei Veteran General Hospital","Yi-Hsiu Huang","中国台湾","台北","台北"],["Taichung Veterans General Hospital","Shian-Shiang Wang","中国台湾","台中","台中"],["Linkuo Chang Gung Memorial Hospital","Kai-Jie Yu","中国台湾","桃园","桃园"],["Tung's Taichung MetroHarbor Hospital, Wuchi Main Campus","Yen-Chuan Ou","中国台湾","台中","台中"],["Kaohsiung Chang Gung Memorial Hospital","Yu-Li Su","中国台湾","高雄","高雄"],["AZ Sint-Jan","Brouwers, Barbara","比利时","West-Vlaanderen","Brugge"],["AZ Maria Middelares","Vulsteke, Christophe","比利时","Vlaanderen","Gent"],["GZA Ziekenhuizen - campus St Augustinus","Strijbos, Michiel","比利时","Antwerpen","Wilrijk"],["Az Groeninge","Demasure, Sofie","比利时","West-Vlaanderen","Kortrijk"],["CHU Helora Hospital La Louvière Site Jolimont","Grisay, Guillaume","比利时","Region Wallonne","La Louviere"],["CHC Montlégia","Matus, Geoffrey","比利时","Waals Gewest","Liege"],["Clinique Saint Pierre","Whenham, Nicolas","比利时","Region wallonne","Ottignies"],["Ghent University Hospital","Rottey, Sylvie","比利时","Oost Vlaanderen","Ghent"],["Cliniques Universitaires Saint Luc","Tombal, Bertrand","比利时","Bruxelles","Bruxelles"],["Fundacao Antonio Prudente A C Camargo Cancer Center","Milena Shizue Tariki","巴西","SP","Sao Paulo"],["Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN","Marcelo Roberto Pereira Freitas","巴西","SC","Florianopolis"],["Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia","Celio Kussumoto","巴西","SC","Joinville"],["Liga Norte Riograndense Contra O Cancer","Andrea Juliana Pereira de Santana Gomes","巴西","RN","Natal"],["Associacao Hospitalar Moinhos de Vento","Pedro Isaacsson","巴西","RS","Porto Alegre"],["CHU de Quebec Universite Laval Hopital de l Enfant Jesus","Eric Levesque","加拿大","QC","Quebec"],["Sunnybrook Health Sciences","Daniel Khalaf","加拿大","ON","Toronto"],["BC Cancer Agency","Dr. Kim Chi","加拿大","BC","Vancouver"],["Princess Margret Hospital, UHN","Maria Jiang","加拿大","ON","Toronto"],["Arthur J E Child Comprehensive Cancer Centre","Steven Yip","加拿大","Alberta","Calgary"],["Lakeridge Health","Pawel Zalewski","加拿大","ON","Oshawa"],["Centre hospitalier Lyon-Sud","Denis Maillet","法国","Auvergne Rhone Alpes","Pierre Benite"],["Centre Georges Francois Leclerc","Sylvain Ladoire","法国","NA","Dijon"],["Institut Gustave Roussy","Karim Fizazi","法国","IDF","Villejuif Cedex"],["Institut Bergonié","Guilhem Roubaud","法国","Nouvelle Aquitaine","Bordeaux"],["Institut de Cancerologie Strasbourg Europe ICANS","Philippe Barthelemy","法国","Alsace","Strasbourg"],["Centre Leon Berard","Aude Flechon","法国","Auvergne Rhone Alpes","Lyon Cedex 8"],["ICH Hopital Morvan","Benjamin Auberger","法国","NA","Brest"],["UNICANCER - Centre Oscar Lambret","Eric Amela","法国","Hauts de France","Lille"],["Institut de cancerologie de Lorraine","Vincent Massard","法国","NA","Vandoeuvre les Nancy"],["Institut de Cancerologie de l'Ouest - site René Gauducheau","Emmanuelle Bompas","法国","NA","Saint Herblain Cedex"],["Hopital Saint Joseph","Carole Helissey","法国","IDF","Paris"],["University Hospital Muenster","Martin Boegemann","德国","NRW","Muenster"],["Universty Hospital Essen","Christopher Darr","德国","NRW","Essen"],["Urologicum Duisburg","Eva Hellmis","德国","NA","Duisburg"],["Universitaetsklinikum Duesseldorf","Guenter Niegisch","德国","NA","Duesseldorf"],["Klinikum rechts der Isar - III. Med. Klinik und Poliklinik","Margitta Retz","德国","NA","Muenchen"],["Studienpraxis Urologie Nuertingen","Tilmann Todenhoefer","德国","NA","Nurtingen"],["Martini-Klinik am UKE GmbH","Gunhild von Amsberg","德国","NA","Hamburg"],["Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)","Stefanie Zschaebitz","德国","NA","Heidelberg"],["Klinikum Nuernberg Nord","Marinela Augustin","德国","NA","Nuernberg"],["Krankenhaus Nordwest GmbH","Mohammed Rafiyan","德国","NA","Frankfurt am Main"],["Stadtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer","Lukas Manka","德国","NA","Braunschweig"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Giuseppe Procopio","意大利","Lombardia","Milano"],["IOV IRCCS sede di Castelfranco Veneto","Marco Maruzzo","意大利","Treviso","Castelfranco Veneto"],["A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette","Massimo Di Maio","意大利","Piemonte","Torino"],["Azienda Ospedaliera Universitaria Federico II","Luigi Formisano","意大利","Campania","Napoli"],["Ospedali Riuniti Foggia","Vincenza Conteduca","意大利","NA","Foggia"],["Azienda Di Rilievo Nazionale E Di Alta Specializzazione","Carlo Messina","意大利","Sicilia","Palermo"],["Fondazione Policlinico Universitario A Gemelli IRCCS","Roberto Iacovelli","意大利","Lazio","Roma"],["Istituto Clinico Humanitas","Paolo Zucali","意大利","Lombardia","Rozzano"],["Yokohama City University Hospital","Ito, Yusuke","日本","Kanagawa","Yokohama"],["Yokosuka Kyosai Hospital","Kobayashi, Kazuki","日本","Kanagawa","Yokosuka"],["Saitama Medical University (SMU) - International Medical Center - Comprehensive Cancer Center","Shirotake, Suguru","日本","Saitama","Hidaka"],["Toho University Sakura Medical Center","Suzuki, Hiroyoshi","日本","Chiba","Sakura"],["Kyushu University Hospital","Shiota, Masaki","日本","Fukuoka","Fukuoka"],["Kobe University Hospital","Miyake, Hideaki","日本","Hyogo","Kobe"],["National Hospital Organization Tokyo Medical Center","Monma, Tetsuo","日本","Tokyo","Meguro ku"],["Yokohama City University Medical Center","Uemura, Hiroji","日本","Kanagawa","Yokohama"],["Kanazawa University Hospital","Mizokami, Atsushi","日本","Ishikawa","Kanazawa"],["National Hospital Organizaiton Shikoku Cancer Center","Hashine, Katsuyoshi","日本","Ehime","Matsuyama"],["National Cancer Center Hospital East","Matsubara, Nobuaki","日本","Chiba","Kashiwa"],["Martini Ziekenhuis","Bart Kuenen","荷兰","NA","Groningen"],["Maastricht UMC","Thomas Kerkhofs","荷兰","LI","Maastricht"],["Erasmus MC","Debbie Robbrecht","荷兰","NA","Rotterdam"],["Tergooi","Pieter van den Berg","荷兰","NH","Hilversum"],["Reinier de Graaf Gasthuis","Addy van de Luijtgaarden","荷兰","NA","Delft"],["Spaarne Ziekenhuis","Aart Beeker","荷兰","Noord Holland","Hoofddorp"],["Isala Kliniek","Metin Tascilar","荷兰","Overijssel","Zwolle"],["Canisius-Wilhelmina ZH","Marieke Berends","荷兰","NA","Nijmegen"],["IN VIVO Sp. z o.o","Marcin Zaremba","波兰","Kujawsko Pomorskie","Bydgoszcz"],["Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie","Mariusz Kwiatkowski","波兰","NA","Koszalin"],["Uniwersytecki Szpital Kliniczny w Bialymstoku","Jacek Kudelski","波兰","Wojewdztwo podlaskie","Bialystok"],["Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie","Pawel Wiechno","波兰","NA","Warszawa"],["Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O","Iwona Skoneczna","波兰","NA","Warszawa"],["Samsung Medical Center","Se Hoon Park","韩国","Seoul","Seoul"],["Asan Medical Center","Jae Lyun Lee","韩国","Seoul Teugbyeolsi","Seoul"],["Severance Hospital Yonsei University Health System","Sang Joon Shin","韩国","Seoul","Seoul"],["National Cancer Center","JaeYoung Joung","韩国","Gyeonggi do","Goyang si"],["Chonnam National University Hwasun Hospital","Woo Kyun Bae","韩国","Jeonranamdo","Jeollanam-do"],["The Catholic University of Korea Seoul St. Mary's Hospital","In-Ho Kim","韩国","Seoul","Seoul"],["Chungnam National University Hospital","Hyo Jin Lee","韩国","Daejeon","Daejeon"],["Hosp. Univ. Vall d′Hebrón","Joaquín Mateo","西班牙","CT","Barcelona"],["Hosp. Univ. Virgen de la Victoria","Lucía Oliva","西班牙","AN","Malaga"],["Hosp. Univ. Ramon y Cajal","Teresa Alonso","西班牙","MD","Madrid"],["Hosp. Univ. 12 de octubre","Elena Castro","西班牙","MD","Madrid"],["Hospital de Jerez","Ana Isabel Vacas","西班牙","AN","Jerez de la Frontera"],["Icon Cancer Care (Adelaide)","Craig Gedye","澳大利亚","SA","Kurralta Park"],["Warringal Private Hospital","Andrew Weickhardt","澳大利亚","VIC","Heidelberg"],["Princess Alexandra Hospital","Aaron Hanson","澳大利亚","QLD","Woolloongabba"],["Peter MacCallum Cancer Centre","Shahneen Sandhu","澳大利亚","VIC","Melbourne"],["Fiona Stanley Hospital","Thomas Ferguson","澳大利亚","WA","Murdoch"],["The Royal Marsden NHS Trust","Alison Reid","英国","SURREY","SUTTON"],["University College Hospital London","Gert Attard","英国","NA","London"],["The Christie Hospital","Andrew Hudson","英国","Manchester","Manchester"],["Univeristy Hospitals Birmingham","Robert Stevenson","英国","NA","Birmingham"],["Keystone Urology Specialists (Lancaster Urology)","Paul Sieber","美国","PA","Lancaster"],["Midlantic Urology","Laurence Belkoff","美国","PA","Bala Cynwyd"],["University of Puerto Rico at Rio Piedras","Josslyn Molina-Avila","美国","PR","Rio Piedras"],["Colorado Clinical Research","David Cahn","美国","CO","Lakewood"],["Hospital Auxilio Mutuo Hato Rey Puerto Rico","Jose Lozada","美国","PR","Hato Rey"],["Carolina Urologic Research Center","Neal Shore","美国","SC","Myrtle Beach"],["XCancer Omaha NE","Luke Nordquist","美国","NE","Omaha"],["Oregon Urology Institute","Bryan Mehlhaff","美国","OR","Springfield"],["OneOncology","Kathryn Beckermann","美国","TN","Nashville"],["Tennessee Oncology","Kathryn Beckermann","美国","TN","Chattanooga"],["East Jefferson General Hospital","Oliver Sartor","美国","LA","Metairie"],["MD Anderson","Bilal Siddiqui","美国","TX","Houston"],["Urology Clinics of North Texas","Anita Tharian/Pat Fulgham","美国","TX","Dallas"],["Rocky Mtn Cancer Centers (SCRI)","Manojkumar Bupathi","美国","CO","Aurora"],["Northwest Cancer Specialists (SCRI)","Spencer Shao","美国","OR","Portland"],["Johns Hopkins Sydney Kimmel Cancer","Adel Mandl","美国","MD","Baltimore"],["Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital","Adel Mandl","美国","DC","Washington"],["Gibbs Cancer Center","Michael Humeniuk","美国","SC","Spartanburg"],["University Hospital of Cleveland","Pedro Barata","美国","OH","Cleveland"],["University Of Minnesota Medical Center M Health Fairview","Nicholas Zorko","美国","MN","Minneapolis"],["University of Pittsburgh Medical Center (UPMC)","Leonard Appleman","美国","PA","Pittsburgh"],["UCSan Diego","Yu-Wei Chen","美国","CA","La Jolla"],["Houston Methodist Hospital","Eleni Efstathiou","美国","TX","Houston"],["University of Cincinnati","Robert Franklin","美国","OH","Cincinnati"],["Henry Ford Hospital","Clara Hwang","美国","MI","Detroit"],["Utah Cancer Specialists","Stephan Kendall","美国","UT","Salt Lake City"],["University of Kansas (KUMC)","Rahul Parikh","美国","KS","Westwood"],["UPENN","Vivek Narayan","美国","PA","Philadelphia"],["Cedars Sinai Medical Center","Edwin Posadas","美国","CA","Los Angeles"],["Fred Hutchinson Cancer Research Center","Michael Schweizer","美国","WA","Seattle"],["Ralph H Johnson Veterans Hospital","Paul Womble","美国","SC","Charleston"],["Ronald Reagan UCLA Medical Center","Matthew Rettig","美国","CA","Los Angeles"],["Texas Oncology - El Paso Cancer Treatment Center (SCRI)","Brian Ulrich","美国","TX","Wichita Falls"],["Columbia University Medical Center","Mark Stein","美国","NY","New York"],["Blue Ridge Cancer Care (SCRI)","Donald Vile","美国","VA","Roanoke"],["Moffitt Cancer Center","Jinsong Zhang","美国","FL","Tampa"],["NYU Langone Health Laura and Isaac Perlmutter Cancer Center","David Wise","美国","NY","New York"],["Virginia Cancer Specialists (SCRI)","Chao Yin","美国","VA","Fairfax"],["University of Colorado","Laura Graham","美国","CO","Aurora"],["Levine Cancer Institute","Earle Burgess","美国","NC","Charlotte"],["UT Southwestern","Tian Zhang","美国","TX","Dallas"],["Michael E DeBakey VA Medical Center","Edward Yen","美国","TX","Houston"],["Dana Farber Cancer Institute","Xiao Wei","美国","MA","Boston"],["VA Medical Center","Franklin Huang","美国","CA","San Francisco"],["Oregon Health & Science University","Julie Graff","美国","OR","Portland"],["Virginia Oncology Assoc (SCRI)","Mark Fleming","美国","VA","Norfolk"],["Hartford Hospital Hartford Healthcare Cancer Institute","Michael Sun","美国","CT","Hartford"],["VA Puget Sound Healthcare System","Robert Montgomery","美国","WA","Tacoma"],["Bay Pines VA Healthcare","Michael Shafique","美国","FL","Bay Pines"],["Mission Blood and Cancer","Emily Brugioni","美国","IA","Des Moines"],["Florida Cancer Specialists (FCS) South","Elizabeth Guancial","美国","FL","Fort Myers"],["University of Iowa Hospital and Clinics","Emily Brugioni","美国","IA","Iowa City"],["NYU Langone Hospital Long Island","David Wise","美国","NY","Mineola"],["NYU Langone Hospitals","David Wise","美国","NY","Brooklyn"],["University of Michigan Health System","Zachery Reichert","美国","MI","Ann Arbor"]]

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","2025-08-29"]]

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: 67 ； 国际: 663 ；
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；