登记号
CTR20253443
相关登记号
曾用名
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
子宫内膜癌
试验通俗题目
比较 T-DXd与 SoC化疗作为子宫内膜癌辅助治疗的试验
试验专业题目
一项德曲妥珠单抗对比标准化疗作为辅助治疗（联合或不联合放疗）治疗 HER2表达（IHC 3+/2+）的子宫内膜癌的 III期、多中心、随机、开放性试验
试验方案编号
DS8201-854
方案最近版本号
2.0
版本日期
2025-06-30
方案是否为联合用药
否
申请人信息
申请人名称
联系人姓名
熊玮
联系人座机
021-60397462
联系人手机号
联系人Email
xiong.wei.4t@daiichisankyo.com.cn
联系人邮政地址
上海市-上海市-南京西路1717号会德丰国际广场36楼
联系人邮编
200040
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
本试验旨在评价T-DXd 对比SoC 化疗作为辅助治疗（联合或不联合放疗）治疗HER2 表达（IHC 3+/2+）子宫内膜癌参与者的有效性和安全性。
随机化
随机化
盲法
开放
试验范围
国际多中心试验
设计类型
平行分组
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
- 签署ICF 时年龄≥18 岁的成人（如果参与试验的法定知情同意年龄>18 岁，请遵循当地法规要求）
- 经组织学确诊为子宫内膜上皮癌。除肉瘤外，允许其他所有组织学类型（允许癌肉瘤）。
- 新诊断为FIGO 2023 IIC 期（包括IICmp53abn 期）或III 期。注：FIGO 2023 IIC 期包括累及任何子宫肌层的侵袭性组织学类型疾病（侵袭性组织学类型包括高级别EEC（3级）、浆液性癌、透明细胞癌、未分化癌、混合型癌、中肾样癌、胃肠道粘液型癌和癌肉瘤）。FIGO 2023 III 期包括任何组织学亚型肿瘤局部和/或区域性扩散疾病。
- 根据2016 年ASCO-CAP 胃癌IHC 评分指南，经中心实验室检测确认存在HER2 表达（IHC 3+/2+）。
- 有足够的存档肿瘤组织样本（强烈建议使用手术获得的样本）可供中心实验室评估HER2 状态。
排除标准
- 患有子宫间充质肿瘤，如子宫内膜间质肉瘤、平滑肌肉瘤或其他类型的纯肉瘤。腺肉瘤也不允许参与。
- 患有复发性或FIGO 2023 IV 期癌。
- 经BICR 评估确定手术后存在可测量的残留肿瘤。
- 通过获批和/或经验证的当地检测确定已知携带POLE 突变（根据当地法规[如适用]）
- 存在心肌梗死（随机化/入组前6 个月内）、症状性慢性心力衰竭（NYHA II 至IV级）病史。筛选时肌钙蛋白水平高于ULN（由生产商定义）且无任何心肌梗死相关症状的参与者，应在筛选期间进行心脏科会诊以排除心肌梗死。
- 根据筛选时三次重复12 导联ECG 的平均值，QTcF 延长至>480 ms。因并发肺部疾病导致的临床重度肺损伤，包括但不限于任何基础肺疾病（即试验入组前3 个月内发生的肺栓塞、重度哮喘、重度COPD、限制性肺疾病、胸腔积液等）和任何自身免疫性、结缔组织或炎症性疾病潜在累及肺部（即类风湿关节炎、舍格林综合征、结节病等）或既往全肺切除术。
- 7. 有需要皮质类固醇治疗的（非感染性）ILD/非感染性肺炎病史，目前患有ILD/非感染性肺炎，或筛选时存在无法通过影像检查排除的疑似ILD/非感染性肺炎。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:DS-8201a 100mg注射液
|
剂型:冻干粉剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:卡铂
|
剂型:输注用浓溶液
|
|
中文通用名:卡铂
|
剂型:输注用浓溶液
|
|
中文通用名:顺铂注射液
|
剂型:注射液
|
|
中文通用名:多西他赛注射液
|
剂型:注射液
|
|
中文通用名:紫杉醇注射液
|
剂型:注射液
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 通过BICR 或组织病理学确认疾病复发(根据当地评估)所评估的无疾病生存期 | 从随机化至首次记录到局部区域性复发、远处转移或全因死亡（以先发生者为准），最长约51个月 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 总生存期 | 从随机化日期至全因死亡日期，最长约63个月 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 朱笕青 | 医学博士 | 主任医师 | 13605818467 | zjq-hz@126.com | 浙江省-杭州市-拱墅区半山东路1号 | 310022 | 浙江省肿瘤医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 浙江省肿瘤医院 | 朱笕青 | 中国 | 浙江省 | 杭州市 |
| 天津市肿瘤医院 | 王珂 | 中国 | 天津市 | 天津市 |
| 海南省人民医院 | 朱根海 | 中国 | 海南省 | 海口市 |
| 福建省肿瘤医院 | 林安 | 中国 | 福建省 | 福州市 |
| 宜宾市第二人民医院 | 汪善兵 | 中国 | 四川省 | 宜宾市 |
| 中南大学湘雅医院 | 张瑜 | 中国 | 湖南省 | 长沙市 |
| 温州医科大学附属第一医院 | 颜笑健 | 中国 | 浙江省 | 温州市 |
| 四川大学华西第二医院 | 尹如铁 | 中国 | 四川省 | 成都市 |
| 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 |
| 河南省肿瘤医院 | 王莉 | 中国 | 河南省 | 郑州市 |
| 西安交通大学第一附属医院 | 安瑞芳 | 中国 | 陕西省 | 西安市 |
| 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 | 陈刚 | 中国 | 湖北省 | 武汉市 |
| 华中科技大学同济医学院附属协和医院 | 李贵玲 | 中国 | 湖北省 | 武汉市 |
| 山东省肿瘤医院 | 李大鹏 | 中国 | 山东省 | 济南市 |
| 吉林大学第一医院 | 魏振彤 | 中国 | 吉林省 | 长春市 |
| 中国医科大学附属盛京医院 | 高嵩 | 中国 | 辽宁省 | 沈阳市 |
| 临沂市肿瘤医院 | 李秀敏 | 中国 | 山东省 | 临沂市 |
| 烟台毓璜顶医院 | 杨瑛 | 中国 | 山东省 | 烟台市 |
| 云南省肿瘤医院 | 杨宏英 | 中国 | 云南省 | 昆明市 |
| 江西省妇幼保健院 | 何林生 | 中国 | 江西省 | 南昌市 |
| 郑州大学第二附属医院 | 赵虎 | 中国 | 河南省 | 郑州市 |
| 安徽省立医院 | 周颖 | 中国 | 安徽省 | 合肥市 |
| 浙江大学医学院附属妇科医院（浙江省妇女保健院） | 吕卫国 | 中国 | 浙江省 | 杭州市 |
| 复旦大学附属妇产科医院 | 王超 | 中国 | 上海市 | 上海市 |
| 上海市第一妇婴保健院 | 万小平 | 中国 | 上海市 | 上海市 |
| 上海市第十人民医院 | 陈晓军 | 中国 | 上海市 | 上海市 |
| 辽宁省肿瘤医院 | 王丹波 | 中国 | 辽宁省 | 沈阳市 |
| Sunnybrook Health Sciences Centre | Gien Lilian | Canada | Ontario | Toronto |
| McGill University Health Centre/Glen Site / Royal Victoria Hospital | Gilbert Lucy | Canada | Quebec | Montreal |
| CHUM | Samouelian Vanessa | Canada | Quebec | Montreal |
| Cross Cancer Institute | Sabourin Jeannelle | Canada | Alberta | Edmonton |
| Health Sciences Centre Winnipeg | Altman Alon | Canada | Manitoba | Winnipeg |
| Avera Medical Group Gynecologic Oncology Sioux Falls | Starks David | United States | South Dakota | Sioux Falls |
| Texas Oncology, P.A. - Tyler | Priebe Anna | United States | South Dakota | Sioux Falls |
| Willamette Valley Clinical Studies | Anderson Charles | United States | Oregon | Eugene |
| Icahn School of Medicine at Mount Sinai PRIME | Blank Stephanie | United States | New York | New York |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health | Pothuri Bhavana | United States | New York | New York |
| UC San Diego Moores Cancer Center | Eskander Ramez | United States | California | La Jolla |
| The University of Chicago Medical Center | Kurnit Katherine | United States | Illinois | Chicago |
| Optimum Clinical Research Group | Finkelstein Karen | United States | New Mexico | Albuquerque |
| Texas Oncology San Antonio Medical Center | Santillan-Gomez Antonio | United States | Texas | San Antonio |
| Brown University - Women and Infant's Hospital | Oliver Matthew | United States | Rhode Island | Providence |
| Trials365 LLC | Black Destin | United States | Louisiana | Shreveport |
| Northwest Cancer Specialists, P.C | Wysham Weiya | United States | Oregon | Tigard |
| Minnesota Oncology Hematology, P.A. | Mallen Adrianne | United States | Minnesota | Coon Rapids |
| Ohio State University | Backes Floor | United States | Ohio | Columbus |
| HonorHealth Research Institute | Willmott Lyndsay | United States | Arizona | Scottsdale |
| Texas Oncology - Bedford | Messing Mark | United States | Texas | Bedford |
| Mount Sinai Medical Center | Slomovitz Brian | United States | Florida | Miami Beach |
| Miami Cancer Institute | Diaz John | United States | Florida | Miami |
| Parkview Research Center | Menzies Anya | United States | Indiana | Fort Wayne |
| Novant Health Huntersville Medical Center | Fauci Janelle | United States | North Carolina | Charlotte |
| Intermountain Health West End Clinic | Petersen Megan | United States | Montana | Billings |
| Western Pennsylvania Hospital | Crafton Sarah | United States | Pennsylvania | Pittsburgh |
| Florida Cancer Specialists East | Monk Bradley | United States | Florida | West Palm Beach |
| Sanford Research / USD-Sioux Falls | Bell Maria | United States | South Dakota | Sioux Falls |
| The Center of Hope Reno | Lim Peter | United States | Nevada | Reno |
| University of Colorado | Corr Bradley | United States | Colorado | Aurora |
| Tufts | Gonzalez Rafael | United States | Massachusetts | Boston |
| Broward Health Medical Center | Jordan Scott | United States | Florida | Ft. Lauderdale |
| FirstHealth of the Carolinas, Inc. | Sundborg Michael | United States | North Carolina | Pinehurst |
| University of Cincinnati Physicians Group, LLC | Jackson Amanda | United States | Ohio | Cincinnati |
| Aretaieio Hospital | Zagouri Flora | Greece | NA | Athens |
| Hospital Mitera | Syrios Ioannis | Greece | NA | Athens |
| St Luke's Hospital | Fountzila Elena | Greece | NA | Thessaloniki |
| University General Hospital Attikon | Koumarianou Anna | Greece | NA | Athens |
| IASO General Clinic | Papadimitriou Christos | Greece | NA | Marousi |
| General Hospital of Athens | Liontos Michail | Greece | NA | Athens |
| Centre Francois Baclesse | Joly Florence | France | Calvados | Caen Cedex 05 |
| Institut Bergonié | Lebreton Coriolan | France | Gironde | Bordeaux cedex |
| CHU Besancon - Hopital Jean Minjoz | Mansi Laura | France | Doubs | Besancon Cedex |
| CHU de Brest - Hopital de la Cavale Blanche | Deiana Laura | France | Finistere | Brest |
| Institut de Cancérologie de Strasbourg Europe - ICANS | Eberst Lauriane | France | Bas Rhin | Strasbourg |
| Institut Sainte Catherine | Billemont Bertrant | France | Vaculuse | Avignon Cedex 9 |
| Centre Antoine Lacassagne | Follana Philippe | France | Alpes Maritimes | Nice |
| CRLCC Eugene Marquis | De La Motte Rouge Thibault | France | Ille et Vilaine | Rennes cedex |
| Institut Claudius Regaud | Gladieff Laurence | France | Haute Garonne | Toulouse |
| Centre Jean Perrin - CLCC | Kalbacher Elsa | France | Puy de Dome | Clermont Ferrand cedex 01 |
| Hopital Privé du Confluent | Blonz Cyriac | France | Loire Atlantique | Nantes cedex 2 |
| Centre de Cancérologie du Grand Montpellier | Guardiola Emmanuel | France | Herault | Montpellier |
| Centre Oscar Lambret | Abdeddaim Cyril | France | Nord | Lille cedex |
| Institut Gustave Roussy | Leary Alexandra | France | Val de Marne | Villejuif cedex |
| Centre Hospitalier Lyon Sud | Peron Julien | France | Rhone | Pierre Benite cedex |
| ICO Girona - Hospital Universitari de Girona Dr Josep Trueta | Barretina Ginesta Pilar | Spain | Girona | Girona |
| Hospital Universitario 12 de Octubre | Manso Sanchez Luis Manuel | Spain | Madrid | Madrid |
| Hospital Universitario La Paz | Redondo Sanchez Andres | Spain | Madrid | Madrid |
| Hospital Clinic de Barcelona | Gaba Garcia Lydia | Spain | Barcelona | Barcelona |
| Instituto Valenciano de Oncologia IVO | Romero Noguera Ignacio | Spain | Valencia | Valencia |
| Complejo Hospitalario Universitario A Coruna | Quindos Varela Maria | Spain | La Coruna | La Coruna |
| Hospital Universitario Virgen Macarena | Gordon Santiago Maria Del Mar | Spain | Sevilla | Sevilla |
| Hospital Universitario Virgen de la Arrixaca | Puertes Boix Ana | Spain | Murcia | El Palmar |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol | Guillen Sentis Pau | Spain | Barcelona | Badalona |
| Hospital Universitari Son Espases | Justo de la Pena Marina | Spain | Baleares | Palma de Mallorca |
| Hospital Universitario Ramon y Cajal | Cortes Salgado Alfonso | Spain | Madrid | Madrid |
| Hospital Universitari Vall d'Hebron - VHIO | Garcia Illescas David | Spain | Barcelona | Barcelona |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Abreu Miguel | Portugal | NA | Porto |
| Centro Hospitalar e Universitário de Coimbra E.P.E. | M C Rodrigues Joana | Portugal | NA | Coimbra |
| Hospital da Luz | Nave Mónica | Portugal | NA | Lisboa |
| Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E. | Marques Cristiana | Portugal | NA | Vila Nova de Gaia |
| IEO Istituto Europeo di Oncologia | Colombo Nicoletta | Italy | Milano | Milano |
| Ospedale San Raffaele | Mangili Giorgia | Italy | Milano | Milano |
| Humanitas San Pio X | Lorusso Domenica | Italy | Milano | Milano |
| IOV - Istituto Oncologico Veneto IRCCS | Guarneri Valentina | Italy | Padova | Padova |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Zamagni Claudio | Italy | Bologna | Bologna |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Raspagliesi Francesco | Italy | Milano | Milano |
| Ospedale Mauriziano Umberto I | Ferrero Annamaria | Italy | Torino | Torino |
| Istituto Nazionale Tumori Fondazione G. Pascale | Pisano Carmela | Italy | Napoli | Napoli |
| Fondazione IRCCS San Gerardo dei Tintori | Canova Stefania | Italy | Milano | Monza |
| Azienda Ospedaliera Universitaria Careggi | Petrella Maria Cristina | Italy | Firenze | Firenze |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Fagotti Anna | Italy | Roma | Roma |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Tognon Germana | Italy | Brescia | Brescia |
| Azienda Ospedaliera Universitaria- Università degli Studi della Campania “Luigi Vanvitelli” | Bianco Roberto | Italy | Napoli | Napoli |
| Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia | Bologna Alessandra | Italy | Reggio Emilia | Reggio Emilia |
| Presidio Ospedaliero Alessandro Manzoni di Lecco | Crippa Alessandra | Italy | Lecco | Lecco |
| Nuovo Ospedale degli Infermi | Zavallone Laura | Bari | Biella | Pinderano |
| Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari | Naglieri Emanuele | Bari | Bari | Bari |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawla II w Siedlcach Sp z o o | Bodnar Lubomir | Poland | NA | Siedlce |
| Szpitale Pomorskie spólka z ograniczona odpowiedzialnoscia | Pikiel Joanna | Poland | NA | Gdynia |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Madry Radoslaw | Poland | NA | Poznan |
| Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie | Mackowiak Matejczyk Beata | Poland | NA | Bialystok |
| Uniwersyteckie Centrum Kliniczne | Klasa Mazurkiewicz Dagmara | Poland | NA | Gdansk |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Knapp Pawel | Poland | NA | Bialystok |
| Universitaetsklinikum Duesseldorf AoeR | Fehm Tanja | Germany | Nordrhein Westfalen | Duesseldorf |
| Universitaetsklinikum Ulm | Heublein Sabine | Germany | Baden Wuerttemberg | Ulm |
| Universitaetsklinikum Frankfurt Goethe-Universitaet | Rost Maximilian | Germany | Hessen | Frankfurt |
| Universitaetsklinikum Freiburg | Rautenberg Beate | Germany | Baden Wuerttemberg | Freiburg |
| Klinikum Lippe-Detmold | Ataseven Beyhan | Germany | Nordrhein Westfalen | Detmold |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Wimberger Pauline | Germany | Sachsen | Dresden |
| Kliniken Essen-Mitte | Welz Julia | Germany | Nordrhein Westfalen | Essen |
| Universitaetsklinikum Hamburg-Eppendorf | Schmalfeldt Barbara | Germany | Hamburg | Hamburg |
| Instituto de Oncologia de Rosario | Micheri Cristian | Argentina | Santa Fe | Rosario |
| Organizacion Medica de Investigacion (OMI) | Alfie Margarita Sonia | Argentina | Buenos Aires | CABA |
| Centro de Investigaciones Medicas Mar del Plata | Barbero Arturo | Argentina | Buenos Aires | Mar del Plata |
| Hospital Aleman | Gomez Abuin Gonzalo | Argentina | Ciudad Autonoma Buenos Aires | Buenos Aires |
| Instituto Medico de la Fundacion Estudios Clinicos | Romitelli Betiana | Argentina | Santa Fe | Rosario |
| Sanatorio Allende Cerro | Cortes Matias | Argentina | Cordoba | Cordoba |
| Sanatorio Privado de la Canada - Cordoba | Fogtman Ruben | Argentina | Cordoba | Cordoba |
| Hospital Italiano de Buenos Aires | Riggi Maria Cecilia | Argentina | Buenos Aires | Ciudad Autonoma Buenos Aires |
| Hospital Provincial del Centenario | Pastor Andrea | Argentina | Santa Fe | Rosario |
| CEMAIC - Centro Medico Privado | Salinas Jorge Emilio | Argentina | Cordoba | Cordoba |
| Instituto Medico Especializado Alexander Fleming | Giornelli Gonzalo | Argentina | Ciudad Autonoma Buenos Aires | Buenos Aires |
| Hospital Britanico de Buenos Aires | Vera Karina | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | Valdez Jorge | Argentina | San Juan | San Juan |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Paiva Carlos Eduardo | Brazil | Sao Paulo | Barretos |
| Fundacao Doutor Amaral Carvalho | Ranzani Brigida | Brazil | Sao Paulo | Jaú |
| INCA - Instituto Nacional de Cancer | de Melo Andreia Cristina | Brazil | Rio do Janeiro | Rio de Janeiro |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Cardoso Guedes Joao Daniel | Brazil | Sao Paulo | Sao Jose Rio Preto |
| Instituto de Cancer de Londrina | Miyasaki Piovesana Mariana | Brazil | Paraná | Londrina |
| CEMEC CTO | Melo Fernandes Bruno | Brazil | Pará | Belem |
| Hospital Haroldo Juacaba - Instituto do Cancer do Ceará | Fernandes Monteiro Maria Marcela | Brazil | Ceará | Fortaleza |
| Centro de Pesquisa Clinica Onconeo | Anjos Sampaio Cristina | Brazil | Mato Grosso | Campo Grande |
| Centro de Pesquisas Oncology Natal | de Almeida Matias Danielli | Brazil | Rio Grande do Norte | Natal |
| Hospital Ernesto Dornelles | Santiago Escovar Carlos Eugenio | Brazil | Rio Grande do Sul | Porto Alegre |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Arima Tiscoski Katsuki | Brazil | Rio Grande do Sul | Porto Alegre |
| Caism Hospital Da Mulher J A Pinotti | Ramalho Susana | Brazil | Sao Paulo | Campinas |
| Centro de Pesquisas do Servico de Ginecologia e Mama do Hospital Araujo Jorge | De Freitas Junior Ruffo | Brazil | Goiás | Goiania |
| ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira | Severino da Silva Samantha Cabral | Brazil | Sao Paulo | Sao Paulo |
| ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho | Marubayashi Patricia | Brazil | Sao Paulo | Sao Paulo |
| Hospital Santa Marcelina | Odebrecht Rocha Roberto | Brazil | Sao Paulo | Sao Paulo |
| Obras Sociais Irma Dulce - Hospital Santo Antonio | Andrade Livia Maria | Brazil | Bahia | Salvador |
| Hospital de Amor da Amazonia | Gurgel Camara Jessica Priscilla | Brazil | Rondonia | Porto Velho |
| Oncocentro - Oncoclinicas do Brasil Servicos Médicos | Nogueira Rodrigues Angelica | Brazil | Minas Gerais | Belo Horizonte |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer | Soares Nunes Joao | Brazil | Paraná | Curitiba |
| IMIP - Instituto de Medicina Integral Professor Fernando Figueira | do Prado Moura Jose Fernando | Brazil | Pernambuco | Recife |
| Centro de Investigaciones Clinicas de la Universidad Catolica | Ibanez Caceres Carolina | Chile | NA | Santiago |
| Biocenter | Rodriguez De Vasquez Esther Mireya | Chile | NA | Concepcion |
| Centro de Estudios Clinicos SAGA | Garrido Salvo Marcelo Adan | Chile | NA | Santiago |
| Centro de Investigacion Clinica Bradford Hill | Gallardo Araneda Carlos | Chile | NA | Santiago |
| Centro de Investigacion del Maule | Leiva Madariaga Juan Enrique | Chile | NA | Talca |
| King Chulalongkorn Memorial Hospital | Manchana Tarinee | Thailand | Bangkok | Pathum Wan |
| Siriraj Hospital | Jaishuen Atthapon | Thailand | Bangkok | Bangkok |
| Maharaj Nakorn Chiang Mai Hospital | Cheewakriangkrai Chalong | Thailand | Chiang Mai | Chiangmai |
| Ramathibodi Hospital | Lertkhachonsuk Arb aroon | Thailand | Bangkok | Bangkok |
| Songklanagarind Hospital | Jiamset Ingporn | Thailand | Songkhla | Hat Yai |
| Saitama Medical University International Medical Center | Hasegawa Kosei | Japan | Saitama-Ken | Hidaka-shi |
| Hyogo Cancer Center | Yamamoto Kasumi | Japan | Hyogo-Ken | Akashi-shi |
| Okayama University Hospital | Nagao Shoji | Japan | Okayama-Ken | Okayama-shi |
| National Cancer Center Hospital | Yonemori Kan | Japan | Tokyo-To | Chuo-ku |
| Cancer Institute Hospital of JFCR | Yunokawa Mayu | Japan | Tokyo-To | Koto-ku |
| Yamagata University Hospital | Nagase Satoru | Japan | Yamagata-Ken | Yamagata-shi |
| Mie University Hospital | Kondo Eiji | Japan | Mie-Ken | Tsu-shi |
| Niigata Cancer Center Hospital | Kikuchi Akira | Japan | Niigata-Ken | Niigata-shi |
| Kurume University Hospital | Nishio Shin | Japan | Fukuoka-Ken | Kurume-shi |
| NHO Kyushu Cancer Center | Ariyoshi Kazuya | Japan | Fukuoka-Ken | Fukuoka-shi |
| Tohoku University Hospital | Shigeta Shogo | Japan | Miyagi-Ken | Sendai-shi |
| Keio University Hospital | Yamagami Wataru | Japan | Tokyo-To | Shinjuku-ku |
| Fukushima Medical University Hospital | Soeda Shu | Japan | Fukushima-Ken | Fukushima-shi |
| NHO Hokkaido Cancer Center | Minobe Shinichiro | Japan | Hokkaido | Sapporo-shi |
| Gunma Prefectural Cancer Center | Nakamura Kazuto | Japan | Gunma-Ken | Ota-shi |
| Osaka International Cancer Institute | Kitai Miho | Japan | Osaka-Fu | Osaka-shi |
| Shizuoka Cancer Center | Kado Nobuhiro | Japan | Shizuoka-Ken | Sunto-gun |
| Seoul National University Hospital | Kim Jae-Weon | Korea, Republic of | Not Applicable | Seoul |
| Severance Hospital, Yonsei University Health System | Lee Jung-Yun | Korea, Republic of | Not Applicable | Seoul |
| National Cancer Center | Lim Myong Cheol | Korea, Republic of | Gyeonggi-do | Goyang-si |
| Seoul National University Bundang Hospital | Kim Kidong | Korea, Republic of | Gyeonggi-do | Seongnam |
| Gangnam Severance Hospital, Yonsei University Health System | Kim Jae Hoon | Korea, Republic of | Not Applicable | Seoul |
| Korea University Anam Hospital | Song Jae Yun | Korea, Republic of | Not Applicable | Seoul |
| Samsung Medical Center | Lee Yooyoung | Korea, Republic of | Not Applicable | Seoul |
| Asan Medical Center | Lee Shin-Wha | Korea, Republic of | Not Applicable | Seoul |
| Keimyung University Dongsan Hospital | Shin So-Jin | Korea, Republic of | Not Applicable | Daegu |
| Taichung Veterans General Hospital | Lu Chien-Hsing | 中国台湾 | NA | Taichung |
| Taipei Veterans General Hospital | Wang Peng-Hui | 中国台湾 | NA | Taipei |
| MacKay Memorial Hospital_ Taipei Branch | Chang Chih-Long | 中国台湾 | NA | Taipei |
| National Taiwan University Hospital | Wei Lin-Hung | 中国台湾 | NA | Taipei |
| National Cheng Kung University Hospital | Huang Yu-Fang | 中国台湾 | NA | Tainan |
| Gujarat Cancer & Research Institute | Panchal Harsha | India | Gujarat | Ahmedabad |
| HCG Cancer Centre Vadodara | Mahato Pinaki | India | Gujarat | Vadodara |
| Deenanath Mangeshkar Hospital and Research Centre | Deshmukh Chetan Dilip | India | Maharashtra | Pune |
| HCG Manavata Cancer Centre | Vasantrao Nagarkar Rajnish | India | Maharashtra | Nashik |
| Vardhman Mahavir Medical College & Safdarjung Hospital | Kalra Kaushal | India | Delhi | Delhi |
| Hemato Oncology Clinic Ahmedabad Rajpath Branch | Desai Chirag | India | Gujarat | Ahmedabad |
| All India Institute of Medical Sciences | Khurana Sachin | Israel | Delhi | New Delhi |
| The Lady Davis Carmel Medical Center | Segev Yakir | Israel | NA | Haifa |
| Wolfson Medical Center | Levy Tally | Israel | NA | Holon |
| Shaare Zedek | Rosengarten Ora | Israel | NA | Jerusalem |
| Tel Aviv Sourasky Medical Center | Safra Tamar | Israel | NA | Tel Aviv |
| Rambam Medical Center | Matanes Emad | Israel | NA | Haifa |
| Sheba Medical Center | Korach Jacob | Israel | NA | Ramat-Gan |
| Hadassah University Hospital - Ein Kerem | Perry Tamar | Israel | NA | Jerusalem |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 浙江省肿瘤医院医学伦理委员会 | 修改后同意 | 2025-06-24 |
| 浙江省肿瘤医院医学伦理委员会 | 同意 | 2025-08-29 |
试验状态信息
试验状态
进行中-尚未招募
目标入组人数
国内: 130 ；
国际: 710 ；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
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；
试验终止日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
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