北京DS-1062a100mg注射液其他临床试验-在局部晚期或转移性尿路上皮癌受试者中比较Datopotamab Deruxtecan （Dato-DXd）联合卡铂或顺铂与吉西他滨联合卡铂或顺铂的研究

登记号	CTR20254314	试验状态	进行中
申请人联系人	张玉婷	首次公示信息日期	2025-10-30
申请人名称	Daiichi Sankyo, Inc./ 第一三共（中国）投资有限公司/ Baxter Oncology GmbH

登记号	CTR20254314
相关登记号	暂无
药物名称	DS- 1062a 100mg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	尿路上皮癌/膀胱癌
试验专业题目	一项在维恩妥尤单抗（EV）联合帕博利珠单抗治疗期间或之后发生疾病进展的局部晚期或转移性尿路上皮癌（la/mUC）患者中比较Datopotamab Deruxtecan（Dato-DXd）联合卡铂或顺铂与吉西他滨联合卡铂或顺铂的随机、开放性、II/III 期研究。TROPION-Urothelial03（TU03）
试验通俗题目	在局部晚期或转移性尿路上皮癌受试者中比较Datopotamab Deruxtecan （Dato-DXd）联合卡铂或顺铂与吉西他滨联合卡铂或顺铂的研究
试验方案编号	DS1062-328	方案最新版本号	1.0
版本日期:	2025-04-16	方案是否为联合用药	否

申请人名称	[["Daiichi Sankyo, Inc."],["第一三共（中国）投资有限公司"],["Baxter Oncology GmbH"]]
联系人姓名	张玉婷	联系人座机	021-60397452	联系人手机号
联系人Email	zhang.yuting.5v@daiichisankyo.com.cn	联系人邮政地址	上海市-上海市-南京西路1717号会德丰广场36楼	联系人邮编	200040

本试验是一项在EV+帕博利珠单抗联合治疗期间或之后发生疾病进展的la/mUC 患者中比较Dato-DXd+卡铂或顺铂治疗与吉西他滨+卡铂或顺铂治疗的全球、多中心、随机、开放性、II/III期试验。本试验将从A 部分（II 期）开始。在A 部分（II 期）期间，将评估初步有效性和安全性，并将在数据可充分评估活性、安全性和耐受性时确定推荐III 期剂量（RP3D）。III 期部分的启动将基于II 期部分的评估结果，并考虑所有信息。

试验分类	安全性和有效性	试验分期	其他	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	[["签署ICF 时年龄≥18 岁的成人（如果知情同意的法定年龄>18 岁，则遵循当地法规要求）。"],["经组织学或细胞学证实的不可切除局部晚期（T4b，任何N；或任何T，N 2-3）或转移性（任何T、任何N、M1）膀胱、肾盂、输尿管或尿道尿路上皮癌。"],["具有鳞状分化或混合细胞类型的尿路上皮癌（移行细胞）受试者，如果其组织学类型主要为尿路上皮细胞，则仍有有资格入组试验。"],["注1：不允许存在脐尿管、小细胞和腺癌组织学类型。"],["注2：如果存在以下情况，则允许存在非临床活动性前列腺癌病史的la/mUC 受试者入组试验：na. 受试者无影像学证实的前列腺癌转移。nb. 非转移性前列腺癌受试者的PSA 未出现升高（采用经验证或批准的检测方法，通过当地检测确定），定义如下：n-间隔至少1 周的连续2 次测量（在签署知情同意书前4 周内或筛选期内完成）中PSA 出现升高且每次测量的绝对值均不高于2 ng/mL。nc. 受试者目前未接受雄激素去势疗法治疗前列腺癌。"],["必须提供来自存档组织的肿瘤组织样本或新获得的治疗前活检样本，用于探索性生物标志物检测。不得从接受过放疗的病灶中采集肿瘤组织样本，除非可提供文件证实肿瘤组织是在放疗后至少3 个月采集的，并且病灶在放疗后增大/出现。肿瘤组织的数量必须充足（如实验室手册中所定义）。a. 首选最近一次抗癌治疗后且签署知情同意书日期前12 个月内采集的存档组织。"],["研究者认为必须符合接受含顺铂或卡铂化疗方案的资格。如果受试者符合顺铂治疗资格，则将接受顺铂治疗。如果受试者在辅助/新辅助治疗背景下接受吉西他滨、卡铂或顺铂治疗早期UC，则这些化疗方案末次给药的日期必须距离试验药物首次给药至少1 年。如果受试者不符合顺铂治疗资格，则接受卡铂治疗。如果受试者符合以下任何一项标准，则视为不符合顺铂治疗资格：na. GFR<60 mL/min（可使用Cockcroft-Gault 公式、肾脏疾病饮食改良或24小时尿液计算CrCl 来估计GFR）n- 根据研究者的临床判断，GFR≥50 mL/min 且<60 mL/min 但无其他不符合顺铂治疗标准（b、c 和d 项）的受试者可视为符合顺铂治疗资格。nb. NCI-CTCAE≥2 级听力损失nc. NCI-CTCAE≥2 级外周神经病变nd. NYHA III 级心力衰竭"],["必须在1L EV和帕博利珠单抗治疗期间或治疗后出现影像学疾病进展或复发。对于因毒性而在1L 治疗中停用EV 和帕博利珠单抗的受试者，如果在停药后发生疾病进展，则有资格入组试验。对于在新辅助/辅助治疗背景下接受EV（或含vedotin 有效载荷的其他药物）+PD-1/PD-L1 抑制剂治疗且在治疗期间或治疗完成后12 个月内发生疾病进展的受试者，经申办方医学监查员或申办方指定人员批准后，也将考虑让其入组试验。"]]
排除标准	[["既往接受过除EV和帕博利珠单抗联合治疗以外的全身疗法治疗la/mUC。经申办方医学监查员或申办方指定人员批准后，以下受试者可视为有资格入组试验。na. 在1L la/mUC 背景下接受含抗Nectin 4 或vedotin 有效载荷（MMAE 或其他微管抑制剂）的药物联合PD-1/PD-L1 抑制剂治疗期间或治疗后发生疾病进展的受试者。"],["接受过以下任何一种治疗：na. 存在同种异体骨髓或实体器官移植史。nb. 使用本方案中任何禁用药物进行的合并治疗。nc. 既往TROP2 靶向ADC 治疗。"],["患有未受控制或重大的心血管疾病，包括：na. 筛选时QTcF 间期>450 ms（基于重复三次12 导联ECG 的平均值[根据当地读数]）。nb. 随机化前6 个月内发生过心肌梗死。nc. 随机化前6 个月内发生过未受控制的心绞痛。nd. 筛选时NYHA 3 级或4 级充血性心力衰竭（请参见第10.3.2 节）。ne. 未受控制的高血压（随机化前28 天内静息收缩压>160 mmHg 或舒张压>100 mmHg，尽管接受了最大程度的药物治疗仍未好转）。"],["有需要类固醇治疗的非感染性ILD/非感染性肺炎（包括放射性肺炎）病史，目前患有ILD/非感染性肺炎，或筛选时存在无法通过影像学检查排除的疑似ILD/非感染性肺炎。"],["研究者判断的因并发肺部疾病导致的临床重度肺损伤，肺部疾病包括但不限于任何基础肺部疾病（例如，重度哮喘、重度慢性阻塞性肺疾病、限制性肺疾病、胸腔积液等）或任何自身免疫性、结缔组织或炎症性疾病累及肺部（例如，类风湿关节炎、舍格林综合征、结节病等）或既往全肺切除术。"],["既往抗癌治疗的毒性，定义为毒性（脱发除外）尚未恢复至NCI-CTCAE第5.0版≤1 级或基线水平。注：存在研究者认为与既往抗癌治疗相关的慢性、稳定2级的毒性（定义为在随机化前至少3 个月内未恶化至超过2 级毒性，且通过SoC 可控）的受试者可入组试验，包括（但不限于）：na. 抗癌治疗所致的神经病变nb. 既往免疫治疗的残留毒性：1 级或2 级内分泌病，可能包括：？ 甲状腺功能减退症/甲状腺功能亢进症n - I 型糖尿病n - 高血糖症n - 肾上腺功能不全n - 肾上腺炎nc. 皮肤色素减退（白癜风）"]]

试验药

[["中文通用名:DS-1062a100mg注射液 英文通用名:DS-1062aforInjection100mg 商品名称:达卓优","剂型:无菌冻干制剂 规格:100mg/1瓶 用法用量:静脉注射4/6mg/kgIV 用药时程:Q3W"],["中文通用名:顺铂注射液 英文通用名:Cisplatinb 商品名称:NA","剂型:注射液 规格:50mg/50ml 用法用量:70mg/m2静脉输注 用药时程:Q3W，最多6个周期"],["中文通用名:卡铂注射液 英文通用名:Carboplatinb 商品名称:NA","剂型:注射液 规格:150mg/15ml 用法用量:AUC4.5或5（4.5或5mg.min/mL）起始剂量不超过675mg（AUC4.5）和750mg（AUC5） 用药时程:Q3W，最多6个周期"],["中文通用名:卡铂注射液 英文通用名:Carboplatinb 商品名称:NA","剂型:注射液 规格:600mg/60ml 用法用量:AUC4.5或5（4.5或5mg.min/mL）起始剂量不超过675mg（AUC4.5）和750mg（AUC5） 用药时程:Q3W，最多6个周期"]] 序号 名称 用法

对照药

暂未填写此信息 序号 名称 用法

主要终点指标及评价时间	[["A部分（2期）--总缓解率","从2期随机日到首次记录到影像学疾病进展或全因性死亡，以先发生者为准，最长约34个月","有效性指标"],["B部分（3期）--盲态独立中心审查评估的无进展生存期","从3期随机日到首次记录到影像学疾病进展或全因性死亡，以先发生者为准，最长约38个月","有效性指标"],["B部分（3期）-- 盲态独立中心审查评估的总生存期","从3期随机日到全因性死亡，以先发生者为准，最长约38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	[["A部分（2期）--缓解持续时间","从首次记录到客观肿瘤缓解日期至首次记录到影像学疾病进展或全因性死亡，以2期中先发生者为准，最长约34个月","有效性指标"],["B部分（3期）--研究者评估的无进展生存期","从3期随机日首次记录到影像学疾病进展或全因性死亡，以先发生者为准，最长约38个月","有效性指标"],["B部分（3期）--总缓解率","从3期随机日首次记录到影像学疾病进展或全因性死亡，以先发生者为准，最长约38个月","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	郭军	学位	博士	职称	主任医师
	电话	010-88196317	Email	Guoj307@126.com	邮政地址	北京市-北京市-海淀区阜成路52号
	邮编	100142	单位名称	北京肿瘤医院

[["北京肿瘤医院","郭军","中国","北京市","北京市"],["南昌大学第一附属医院","傅斌","中国","江西省","南昌市"],["温州医科大学附属第一医院","余志贤","中国","浙江省","温州市"],["北京大学第一医院","何志嵩","中国","北京市","北京市"],["中国医科大学附属盛京医院","李振华","中国","辽宁省","沈阳市"],["湖南省肿瘤医院","蒋书算","中国","湖南省","长沙市"],["华中科技大学同济医学院附属协和医院","章小平","中国","湖北省","武汉市"],["重庆医科大学附属第一医院","苟欣","中国","重庆市","重庆市"],["山东大学齐鲁医院","史本康","中国","山东省","济南市"],["复旦大学附属肿瘤医院","叶定伟","中国","上海市","上海市"],["浙江大学医学院附属第一医院","赵鹏","中国","浙江省","杭州市"],["吉林大学第一医院","刘子玲","中国","吉林省","长春市"],["福建医科大学附属第一医院","许宁","中国","福建省","福州市"],["南京鼓楼医院","郭宏骞","中国","江苏省","南京市"],["北京医院","万奔","中国","北京市","北京市"],["宁波大学附属第一医院","马琪","中国","浙江省","宁波市"],["中山大学肿瘤医院","刘卓炜","中国","广东省","广州市"],["哈尔滨医科大学附属肿瘤医院","陈辉","中国","黑龙江省","哈尔滨市"],["西安交通大学第二附属医院","李和程","中国","陕西省","西安市"],["昆明医科大学第二附属医院","雷学芬","中国","云南省","昆明市"],["复旦大学附属中山医院","郭剑明","中国","上海市","上海市"],["四川大学华西医院","刘继彦","中国","四川省","成都市"],["华东医院","孙忠全","中国","上海市","上海市"],["天津医科大学肿瘤医院","姚欣","中国","天津市","天津市"],["天津医科大学第二医院","胡海龙","中国","天津市","天津市"],["中山大学肿瘤医院","史艳侠","中国","广东省","广州市"],["浙江省人民医院","董海鹰","中国","浙江省","杭州市"],["浙江大学医学院附属邵逸夫医院","潘宏铭","中国","浙江省","杭州市"],["厦门大学附属第一医院","盛旺","中国","福建省","厦门市"],["吉林省肿瘤医院","张雪莹","中国","吉林省","长春市"],["University of Wisconsin Carbone Cancer Center","Kyriakopoulos, Christos","United States","Wisconsin","Madison"],["Carolina Urologic Research Center","Shore, Neal","United States","South Carolina","Myrtle Beach"],["St Francis Hospital Cancer Center","Dyar, Stephen","United States","South Carolina","Greenville"],["WakeMed Cancer Care","Chaudhary, Vijay","United States","North Carolina","Raleigh"],["Baylor Scott & White Health","Henderson, Sherronda","United States","Texas","Temple"],["The West Clinic","Somer, Bradley","United States","Tennessee","Germantown"],["University of Virginia Health System","Skelton, William","United States","Virginia","Charlottesville"],["Mid-Florida Hematology & Oncology Centers, P.A.","Nair, Santosh","United States","Florida","Orange City"],["Investigational Drug Services Advent Health Orlando","Sonpavde, Guru","United States","Florida","Orlando"],["Banner MD Anderson Cancer Center","Bowman, Isaac","United States","Arizona","Gilbert"],["Baptist Clinical Research Institute, Inc.","Gravenor, Donald","United States","Tennessee","Memphis"],["UNC Hospitals","Milowsky, Matthew","United States","North Carolina","Chapel Hill"],["Thomas Jefferson University","Mille, Patrick","United States","Pennsylvania","Philadelphia"],["UPMC Hillman Cancer Center","Appleman, Leonard","United States","Pennsylvania","Monroeville"],["Icahn School of Medicine at Mount Sinai","Galsky, Matthew","United States","New York","New York"],["University of California San Francisco Cancer Center","Koshkin, Vadim","United States","California","San Francisco"],["MUSC Hollings Cancer Center.","Ho, Thai","United States","South Carolina","Charleson"],["Providence Medical Foundation","Lee, Wes","United States","California","Santa Rosa"],["Illinois Cancer Specialists - Niles","Elms, Destry","United States","Illinois","NILES"],["Vanderbilt University Medical Center","Tan, Alan","United States","Tennessee","Nashville"],["SSM Health Dean Medical Group - Madison","Porter, Ryan","United States","Wisconsin","Madison"],["James Graham Brown Cancer Center","Kumar, Rohit","United States","Kentucky","Louisville"],["Washington University School of Medicine","Reimers, Melissa","United States","Missouri","St. Louis"],["University of California at Irvine Medical Center","Rezazadeh Kalebasty, Arash","United States","California","Orange"],["Rocky Mountain Cancer Centers, LLP","Bupathi, Manojkumar","United States","Colorado","Aurora"],["Henry Ford Columbus Center","Hwang, Clara","United States","Michigan","Detroit"],["University of MN Medical","Okazaki, Ian","United States","Minnesota","Minneapolis"],["UT Southwestern Medical Center","Zhang, Tian","United States","Texas","Dallas"],["Mayo Clinic Arizona","Singh, Parminder","United States","Arizona","Phoenix"],["Summit Cancer Treatment Center","Chaudhry, Arvind","United States","Washington","Spokane"],["St Joseph's Hospital and Medical Center","Torri, Vamsee","United States","Arizona","Phoenix"],["Rhode Island Hospital","Lagos, Galina","United States","Rhode Island","Providence"],["Medical College Of Wisconsin","Nelson, Ariel","United States","Wisconsin","Milwaukee"],["SCRI Oncology Partners","Garmezy, Benjamin","United States","Tennessee","Nashville"],["Virginia Oncology Associates - Hampton","Fleming, Mark","United States","Virginia","Norfolk"],["Texas Oncology, P.A.","Cowey, Charles","United States","Texas","Dallas"],["Texas Oncology P.A. Dallas Presbyterian","Lattanzi, Michael","United States","Texas","Austin"],["Cancer Care Specialists of Illinois","Wade, James","United States","Illinois","O'Fallon"],["Illinois CancerCare PC","MacVicar, Gary","United States","Illinois","Peoria"],["Maryland Oncology Hematology, P.A.","Sinha, Shreya","United States","Maryland","Silver Spring"],["BRCR Medical Center Inc.","Schneider, Andrew","United States","Florida","Tamarac"],["Cancer & Hematology Centers","Batts, Eric","United States","Michigan","Grand Rapids"],["Moores UCSD Cancer Center","Stewart, Tyler","United States","California","La Jolla"],["Northwest Cancer Specialists, P.C","Schnadig, Ian","United States","Oregon","PORTLAND"],["Huntsman Cancer Institute","Swami, Umang","United States","Utah","Salt Lake City"],["Piedmont Cancer Institute","Assikis, Vasileios","United States","Georgia","Atlanta"],["Yale University","Petrylak, Daniel","United States","Connecticut","New Haven"],["Northside Hospital","Satpute, Shailesh","United States","Georgia","Atlanta"],["Comprehensive Hematology Oncology","Makani, Neeharika","United States","Florida","St. Petersburg"],["Stanford School of Medicine","Khaki, Ali","United States","California","Stanford"],["UCLA Hematology Oncology - 100 Med Plaza","Drakaki, Alexandra","United States","California","Los Angeles"],["John Theurer Cancer Center at Hackensack UMC","Alter, Robert","United States","New Jersey","Hackensack"],["UC Davis Comprehensive Cancer Center","Parikh, Mamta","United States","California","Sacramento"],["University of Nebraska Medical Center","Leuva, Harshraj","United States","Nebraska","Omaha"],["University of Cincinnati Cancer Institute","Franklin, Robert","United States","Ohio","Cincinnati"],["Alaska Oncology & Hematology, LLC","Liu, Steven","United States","Alaska","Anchorage"],["Dana-Farber Cancer Institute","McGregor, Bradley","United States","Massachusetts","Boston"],["Mayo Clinic in Florida","Basu, Arnab","United States","Florida","Jacksonville"],["McMaster University","Lalani, Aly-Khan","Canada","Ontario","Hamilton"],["CISSS de la Monteregie-Centre","Sperlich, Catherine","Canada","Quebec","Greenfield Park"],["Q.E. II Health Sciences Centre","Macfarlane, Robyn","Canada","Nova Scotia","Halifax"],["CIC-CHU de Quebec - Universite Laval / Hopital de l’Enfant-Jesus","Morin Coulombe, Antoine","Canada","Quebec","Quebec"],["CIUSSS du Centre Ouest de l'lle de Montreal","Ferrario, Cristiano","Canada","Quebec","Montreal"],["London Health Sciences Centre (LHSC) - Victoria Hospital","Fernandes, Ricardo","Canada","Ontario","London"],["William Osler Health System","Iafolla, Marco","Canada","Ontario","Brampton"],["Sunnybrook Health Sciences Centre","Cheng, Susanna","Canada","Ontario","Toronto"],["CHUM","Hamilou, Zineb","Canada","Quebec","Montreal"],["Arthur J.E. Child Comprehensive Cancer Centre","Alimohamed, Nimira","Canada","Alberta","Calgary"],["University Health Network - Princess Margaret Cancer Centre","Sridhar, Srikala","Canada","Ontario","Toronto"],["Metropolitan Hospital","Koutsoukos, Konstantinos","Canada","NA","Neo Faliro"],["University General Hospital of Larissa","Kotsakis, Athanasios","Canada","NA","Larisa"],["General Hospital of Athens","Liontos, Michail","Greece","NA","Athens"],["University Hospital of Patra","Koutras, Angelos","Greece","NA","Patras"],["General Hospital Papageorgiou","Timotheadou, Eleni","Greece","NA","Thessaloniki"],["Anticancer Hospital of Thessaloniki","Boutis, Anastasios","Greece","NA","Thessaloniki"],["Interbalkan Hospital of Thessaloniki","Kontovinis, Loukas","Greece","NA","Thessaloniki"],["Anticancer-Oncology Hospital of Athens","Tryfonopoulos, Dimitrios","Greece","NA","Athens"],["Athens Medical Center","Tsiatas, Marinos","Greece","NA","Athens"],["University General Hospital Attikon","Bamias, Aristotelis","Greece","NA","Athens"],["UMC Utrecht","Suelmann, Britt","Netherlands","NA","Utrecht"],["Erasmus Medisch Centrum","Robbrecht, Debbie","Netherlands","NA","Rotterdam"],["Radboudumc","Franken, Mira","Netherlands","NA","Nijmegen"],["Maastricht University Medical Center","Kerkhofs, Thomas","Netherlands","NA","Maastricht"],["Amsterdam UMC, Locatie AMC","Voortman, Johannes","Netherlands","NA","Amsterdam"],["CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE","Freres, Pierre","Belgium","NA","Liege"],["Universitair Ziekenhuis Gent","Rottey, Sylvie","Belgium","NA","Gent"],["UZ Leuven","Dumez, Herlinde","Belgium","NA","Leuven"],["UZA","Van den Brande, Jan","Belgium","NA","Edegem"],["AZ Maria Middelares","Vulsteke, Christof","Belgium","NA","Gent"],["Clinique Clementville","Becht, Catherine","France","Herault","Montpellier"],["Hopital Saint-Louis","Dumont, Clement","France","Paris","Paris"],["Hopital Caremeau","Houede, Nadine","France","Gard","Nimes"],["ICO - Site Paul Papin","Abadie-Lacourtoisie, Sophie","France","Maine et Loire","Angers Cedex 2"],["CHU Saint Etienne","Cornillon, Pierre","France","Loire","Saint Etienne Cedex 2"],["Centre Hospitalier Lyon Sud","Maillet, Denis","France","Rhone","Pierre Benite cedex"],["ICO - Site René Gauducheau","Rolland, Frederic","France","Loire Atlantique","Saint Herblain"],["Hopital Européen Georges Pompidou","Oudard, Stephane","France","Paris","Paris"],["Groupe Hospitalier Pitie-Salpetriere","Jaffrelot, Loic","France","Paris","Paris"],["ICL - Alexis Vautrin","Massard, Vincent","France","Meurthe et Moselle","Vandoeuvre les Nancy"],["CHU Bordeaux","Gross-Goupil, Marine","France","Gironde","Bordeaux cedex"],["CHU de Grenoble - Hopital Albert Michallon","Laramas, Mathieu","France","Isere","La tronche"],["Hopital de la Timone","Deville, Jean Laurent","France","Bouches-du-Rhone","Marseille Cedex 5"],["Institut Jean Godinot","Eymard, Jean-Christophe","France","Marne","Reims"],["Centre Jean Perrin - CLCC","Mahammedi, Hakim","France","Puy de Dome","Clermont Ferrand cedex 01"],["CHU Poitiers - Hopital la Milétrie","Emambux, Sheik","France","Vienne","Poitiers"],["Polyclinique de Blois","Laplaige, Philippe","France","Loir et Cher","La Chaussée st Victor"],["Centre Leon Berard","Flechon, Aude","France","Rhone","Lyon"],["Clinique La Croix du Sud","Ricci, Francesco","France","Haute Garonne","Quint Fonsegrives"],["Centre Francois Baclesse","Joly, Florence","France","Calvados","Caen Cedex 05"],["Institut Bergonié","Teyssonneau, Diego","France","Gironde","Bordeaux cedex"],["CHU Brest - Hopital Morvan","Auberger, Benjamin","France","Finistere","Brest Cedex"],["Clinique Victor Hugo - Centre Jean Bernard","Ruffier Loubiere, Amandine","France","Sarthe","Le Mans"],["Institut de Cancérologie de Strasbourg Europe - ICANS","Barthelemy, Philippe","France","Bas Rhin","Strasbourg"],["Clinique de l'Europe","Hocine, Faycal","France","Somme","Amiens"],["Institut Paoli Calmettes","Gravis, Gwenaelle","France","Bouches-du-Rhone","Marseille cedex 9"],["Hopital Henri Mondor","Joly, Charlotte","France","Val de Marne","Créteil Cedex"],["CHD Vendee","Bihan, Celine","France","Vendee","LA Roche Sur Yon"],["Private Hospital of Confluent SAS","El Kouri, Claude","France","Loire Atlantique","Nantes"],["Institut du Cancer de Montpellier","Corbeau, Ileana","France","Herault","Montpellier Cedex 5"],["Institut Claudius Regaud - Oncopole","Pouessel, Damien","France","Haute Garonne","Toulouse"],["Centre Hospitalier de Calais","Ibrahim, Nathalie","France","Pas de Calais","Calais"],["CHU Besancon - Hopital Jean Minjoz","Goujon, Morgan","France","Doubs","Besancon Cedex"],["Institut Gustave Roussy","Loriot, Yohann","France","Val de Marne","Villejuif cedex"],["Hospital Quironsalud Barcelona","Racca Bussano, Fabricio","Spain","Barcelona","Barcelona"],["MD Anderson Cancer Centre","Grande Pulido, Enrique","Spain","Madrid","Madrid"],["ICO l'Hospitalet - Hospital Duran i Reynals","Maroto Rey, Jose Pablo","Spain","Barcelona","L'Hospitalet de Llobregat"],["Hospital de la Santa Creu i Sant Pau","Gonzalez Cordero, Marta","Spain","Barcelona","Barcelona"],["Hospital Universitario Badajoz","Gonzalez Cordero, Marta","Spain","Badajoz","Badajoz"],["Hospital Universitario Reina Sofia","Mendez Vidal, Maria Jose","Spain","Córdoba","Cordoba"],["Hospital Universitario 12 de Octubre","Castellano Gauna, Daniel Ernesto","Spain","Madrid","Madrid"],["ICO Girona - Hospital Universitari de Girona Dr Josep Trueta","Sala Gonzalez, Nuria","Spain","Girona","Girona"],["Hospital del Mar","Rodriguez-Vida Rodriguez, Alejo Martin","Spain","Barcelona","Barcelona"],["Hospital Universitario Ramon y Cajal","Gajate Borau, Pablo","Spain","Madrid","Madrid"],["Hospital Universitario Quironsalud Madrid","Almagro Casado, Elena","Spain","Madrid","Pozuelo de Alarcon"],["Hospital Universitario La Paz","Pinto Marin, Alvaro","Spain","Madrid","Madrid"],["Hospital Universitario Virgen Macarena","Sanchez-Camacho Mejias, Alberto","Spain","Sevilla","Sevilla"],["Hospital General Universitario Gregorio Maranon","Arranz Arija, Jose Angel","Spain","Madrid","Madrid"],["Hospital Universitario Nuestra Senora de Valme","Fernandez Parra, Eva","Spain","Sevilla","Sevilla"],["Hospital Regional Universitario de Malaga","Montesa Pino, Alvaro","Spain","Málaga","Málaga"],["Hospital Universitari i Politecnic La Fe","Girones Sarrio, Regina","Spain","Valencia","Valencia"],["Hospital Clinic de Barcelona","Reig Torras, Oscar","Spain","Barcelona","Barcelona"],["Hospital Universitario Lucus Augusti","Vazquez Estevez, Sergio","Spain","Lugo","Lugo"],["Centro Ricerche Cliniche di Verona s.r.l.","Zivi, Andrea","Italy","Verona","Verona"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Berruti, Alfredo","Italy","Brescia","Brescia"],["Azienda Ospedaliero-Universitaria S. Luigi Gonzaga","Buttigliero, Consuelo","Italy","Torino","Orbassano"],["ASL Napoli 2 Nord Santa Maria delle Grazie","Facchini, Gaetano","Italy","Napoli","Pozzuoli"],["Azienda Ospedaliero Universitaria Pisana","Galli, Luca","Italy","Pisa","Pisa"],["Istituto Clinico Humanitas","Perrino, Matteo","Italy","Milano","Rozzano"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Procopio, Giuseppe","Italy","Milano","Milano"],["Istituto Nazionale Tumori Regina Elena IRCCS","Calabro, Fabio","Italy","Roma","Roma"],["ASST Ovest Milanese - Ospedale Civile di Legnano","Luciani, Andrea","Italy","Milano","Legnano"],["Fondazione del Piemonte per l'Oncologia IRCCS Candiolo","Mosca, Alessandra","Italy","Torino","Candiolo"],["Azienda Ospedaliera S. Maria Di Terni","Guida, Annalisa","Italy","Terni","Terni"],["Humanitas Gavazzeni","Cocorocchio, Emilia","Italy","Bergamo","Bergamo"],["Ospedale San Raffaele","Necchi, Andrea","Italy","Milano","Milano"],["Istituto Nazionale Tumori Fondazione G. Pascale","Tambaro, Rosa","Italy","Napoli","Napoli"],["IRCCS Ospedale Policlinico San Martino","Fornarini, Giuseppe","Italy","Genova","Genova"],["Fakultni nemocnice Olomouc","Melichar, Bohuslav","Czech Republic","NA","Olomouc"],["Fakultni nemocnice v Motole","Buchler, Tomas","Czech Republic","NA","Praha 5"],["Vseobecna fakultni nemocnice v Praze","Mateju, Martin","Czech Republic","NA","Praha 2"],["Krankenhaus der barmherzigen Bruder","Meran, Johannes","Austria","NA","Wien"],["Medizinische Universitat Innsbruck","Pichler, Renate","Austria","NA","Innsbruck"],["Ordensklinikum Linz GmbH Elisabethinen","Kiesl, David","Austria","NA","Linz"],["Universitatsklinikum Krems","Vallet, Sonia","Austria","NA","Krems"],["LKH-Univ. Klinikum Graz","Terbuch, Angelika","Austria","NA","Graz"],["LKH - Universitatsklinikum der PMU Salzburg","Gampenrieder, Simon","Austria","NA","Salzburg"],["AKH - Medizinische Universitat Wien","Gust, Kilian","Austria","NA","Vienna"],["Klinik Ottakring","Niedersuess-Beke, Dora","Austria","NA","Vienna"],["Alborg Universitets Hospital","Carus, Andreas","Denmark","NA","Alborg"],["Arhus Universitetshospital","Agerbaek, Mads","Denmark","NA","Arhus N"],["Sjallands University Hospital","Yakymenko, Dorthe","Denmark","NA","Naestved"],["Rigshospitalet","Pappot, Helle","Denmark","NA","Copenhagen"],["OUH","Jensen, Niels","Denmark","NA","Odense C"],["Herlev og Gentofte Hospital","Dohn, Line","Denmark","NA","Herlev"],["Akershus University Hospital","Syed, Mohsan","Norway","NA","Nordbyhagen"],["Sykehuset i Vestfold HF","Taran, Marius","Norway","NA","Toensberg"],["Stavanger Universitetssjukehus, Helse Stavanger HF","Vigmostad, Maria","Norway","NA","Stavanger"],["Universitaetsklinikum Heidelberg","Zschaebitz, Stefanie","Germany","Baden Wuerttemberg","Heidelberg"],["Studienpraxis Urologie Drs. Feyerabend","Todenhoefer, Tilman","Germany","Baden Wuerttemberg","Nuertingen"],["Universitaetsklinikum Halle (Saale)","Gakis, Georgios","Germany","Sachsen Anhalt","Halle"],["Universitaetsmedizin Goettingen","Farid Meck, Arian","Germany","Niedersachsen","Goettingen"],["Klinikum Stuttgart-Katharinenhospital","Bedke, Jens","Germany","Baden Wuerttemberg","Stuttgart"],["Marien Hospital Herne - Universitatsklinikum der Ruhr-Universitaet Bochum","Roghmann, Florian","Germany","Nordrhein Westfalen","Herne"],["Universitaetsklinikum Carl Gustav Carus TU Dresden","Thomas, Christian","Germany","Sachsen","Dresden"],["Universitaetsklinikum Jena","Grimm, Marc-Oliver","Germany","Thueringen","Jena"],["Universitaetsklinikum Aachen AOeR","Saar, Matthias","Germany","Nordrhein Westfalen","Aachen"],["Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt","Schmalenberg, Harald","Germany","Sachsen","Dresden"],["Urologicum Dr. med. Ralf Eckert","Eckert, Ralf","Germany","Sachsen Anhalt","Lutherstadt Eisleben"],["Klinikum rechts der Isar der TU Muenchen","Retz, Margitta","Germany","Bayern","Muenchen"],["Asklepios Klinik Altona","Wuelfing, Christian","Germany","Hamburg","Hamburg"],["Universitaetsklinikum Schleswig Holstein Campus Kiel","Rodler, Severin","Germany","Schleswig Holstein","Kiel"],["Universitaetsklinikum Ulm","Zengerling, Friedemann","Germany","Baden Wuerttemberg","Ulm"],["Universitaetsklinikum Essen","Gruenwald, Viktor","Germany","Nordrhein Westfalen","Essen"],["Universitaetsmedizin Mannheim","Wessels, Frederik","Germany","Baden Wuerttemberg","Mannheim"],["Universitaetsklinikum Schleswig Holstein - Campus Luebeck","Merseburger, Axel S.","Germany","Schleswig Holstein","Luebeck"],["LMU-Campus Grosshadern","Casuscelli, Jozefina","Germany","Bayern","Muenchen"],["Universitaetsklinikum Koeln (AoeR)","Heidenreich, Axel","Germany","Nordrhein Westfalen","Koeln"],["Universitaetsklinikum Tuebingen","Rausch, Steffen","Germany","Baden Wuerttemberg","Tuebingen"],["Hospital Sirio Libanes","Cutuli, Hernan","Argentina","Ciudad Autonoma Buenos Aires","Caba"],["Investigaciones CORI S.R.L.","Kaen, Diego Lucas","Argentina","La Rioja","La Rioja"],["Hospital Universitario Austral","Passarella, Carolina","Argentina","Buenos Aires","Pilar"],["Hospital Britanico de Buenos Aires","Korbenfeld, Ernesto","Argentina","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["CEMAIC - Centro Medico Privado","Salinas, Jorge Emilio","Argentina","Cordoba","Cordoba"],["Centro de Investigaciones Medicas Mar del Plata","Barbero, Arturo","Argentina","Buenos Aires","Mar del Plata"],["Instituto Medico de la Fundacion Estudios Clinicos","Garbaos, Gabriel","Argentina","Santa Fe","Rosario"],["Hospital Italiano de Buenos Aires","Cayol, Federico","Argentina","Buenos Aires","Ciudad Autonoma Buenos Aires"],["Exelsus SRL","Zarba, Juan Jose","Argentina","Tucuman","San Miguel de Tucumán"],["Sanatorio Parque S.A.","Dri, Alejandro","Argentina","Santa Fe","Rosario"],["Hospital Privado Centro Medico de Cordoba S.A","Sierra, Jeremias Tomas","Argentina","Cordoba","Cordoba"],["Centro Medico Austral","Streich, Guillermo","Argentina","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["COIR Fundacion Centro Oncologico de Integracion Regional","Fernandez Lazzaro, Mauricio German","Argentina","Mendoza","Mendoza"],["Instituto Medico Especializado Alexander Fleming","Sade, Juan Pablo","Argentina","Ciudad Autonoma Buenos Aires","Buenos Aires"],["BP A Beneficencia Portuguesa de Sao Paulo","Schutz, Fabio","Brazil","Sao Paulo","Sao Paulo"],["Instituto Dor de Ensino e Pesquisa - Sao Paulo","Segundo Correia Mota, Jose Mauricio","Brazil","Sao Paulo","Sao-Paulo"],["Instituto Americas","Padoan, Monica Luciana","Brazil","Rio do Janeiro","Rio de Janeiro"],["Instituto Joinvilense de Hematologia e Oncologia","Kussumoto, Celio","Brazil","Santa Catarina","Joinville"],["Centro Gaucho Integrado - Mae de Deus Center","Arrieira Azambuja, Alan","Brazil","Rio Grande do Sul","Porto Alegre"],["Oncoclínicas Rio de Janeiro","Fontes, Mariane","Brazil","Rio do Janeiro","Rio de Janeiro"],["CIONC-Centro Integrado de Oncologia de Curitiba","Costa Maia Vianna, Karina","Brazil","Paraná","Curitiba"],["Hospital Sirio Libanes","Assed Bastos, Diogo","Brazil","Sao Paulo","Sao Paulo"],["Niigata University Medical & Dental Hospital","Anraku, Tsutomu","Japan","Niigata-Ken","Niigata-shi"],["Kyushu University Hospital","Matsumoto, Takashi","Japan","Fukuoka-Ken","Fukuoka-shi"],["Kyoto University Hospital","Sakatani, Toru","Japan","Kyoto-Fu","Kyoto-shi"],["Okayama University Hospital","Katayama, Satoshi","Japan","Okayama-Ken","Okayama-shi"],["Keio University Hospital","Oya, Mototsugu","Japan","Tokyo-To","Shinjuku-ku"],["Sapporo Medical University Hospital","Shindo, Tetsuya","Japan","Hokkaido","Sapporo-shi"],["Toyama University Hospital","Nishiyama, Naotaka","Japan","Toyama-Ken","Toyama-shi"],["University of Tsukuba Hospital","Kandori, Shuya","Japan","Ibaraki-Ken","Tsukuba-shi"],["Nippon Medical School Hospital","Kondo, Yukihiro","Japan","Tokyo-To","Bunkyo-ku"],["Aichi Cancer Center Hospital","Kojima, Takahiro","Japan","Aichi-Ken","Nagoya-shi"],["Hirosaki University Hospital","Hatakeyama, Shingo","Japan","Aomori-Ken","Hirosaki-shi"],["Harasanshin Hospital","Yokomizo, Akira","Japan","Fukuoka-Ken","Fukuoka-shi"],["St. Marianna University Hospital","Kikuchi, Eiji","Japan","Kanagawa-Ken","Kawasaki-shi"],["Kindai University Hospital","Fujita, Kazutoshi","Japan","Osaka-Fu","Osakasayama-shi"],["Cancer Institute Hospital of JFCR","Miura, Yuji","Japan","Tokyo-To","Koto-ku"],["Osaka International Cancer Institute","Nakayama, Masashi","Japan","Osaka-Fu","Osaka-shi"],["Institute of Science Tokyo Hospital","Fukuda, Shohei","Japan","Tokyo-To","Bunkyo-ku"],["Yamaguchi University Hospital","Kobayashi, Keita","Japan","Yamaguchi-Ken","Ube-shi"],["NHO Kumamoto Medical Center","Maeda, Yoshihiro","Japan","Kumamoto-Ken","Kumamoto-shi"],["Kanazawa University Hospital","Izumi, Koji","Japan","Ishikawa-Ken","Kanazawa-shi"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京肿瘤医院医学伦理委员会","修改后同意","2025-09-04"]]

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: 98 ； 国际: 630 ；
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；