登记号
CTR20252204
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
非小细胞肺癌
试验通俗题目
德曲妥珠单抗联合帕博利珠单抗治疗方案相比含铂化疗联合帕博利珠单抗治疗方案作为HER2过表达非小细胞肺癌一线治疗的试验
试验专业题目
一项比较德曲妥珠单抗联合帕博利珠单抗对比铂类化疗联合帕博利珠单抗用于局部晚期不可切除或转移性HER2 过表达且PD-L1 TPS＜50%的非鳞状细胞非小细胞肺癌患者的一线治疗的III 期、多中心、随机、开放性试验（DESTINY-Lung06）
试验方案编号
DS8201-793
方案最近版本号
1.0
版本日期
2024-12-02
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
张思静
联系人座机
021-60397257
联系人手机号
联系人Email
zhangkk6@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
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
本试验是一项多中心、随机、开放性、III期临床试验，旨在评估德曲妥珠单抗（T-DXd；优赫得®）联合帕博利珠单抗治疗方案相比含铂化疗联合帕博利珠单抗治疗方案在PD-L1 TPS<50%且未携带已知AGA的既往未经治疗的局部晚期不可切除或转移性HER2过表达非鳞状NSCLC参与者中的有效性和安全性。
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
男+女
健康受试者
无
入选标准
- 应在进行任何组织筛查程序之前，在组织筛查ICF上签名并注明日期。应在开始任何试验特定的资格认证程序之前，在主ICF上签名并注明日期。应在进行任何药物基因组学程序之前，在可选药物基因组学 ICF（包含在主筛选ICF中）和妊娠伴侣ICF（如适用）上签名并注明日期。
- 签署ICF当日年龄≥18岁的成人参与者。如果当地要求同意参加试验的法定年龄大于18岁，则遵循当地法规要求。
- 患有经组织学证实的局部晚期不可切除或转移性非鳞状NSCLC且符合以下所有标准： 随机化时患有IV期NSCLC疾病或IIIB期或IIIC期疾病，但不适合进行手术切除或接受根治性放化疗（基于AJCC[美国癌症联合委员会]，第8版）。 未携带已知的AGA（基于当地检测的现有检测结果，并且当地有靶向于其AGA的一线晚期/转移性疾病的可用治疗）。 根据现有检测结果（如果存在获批或经验证的当地检测），未携带已知的HER2突变。 注：如果参与者是以腺癌为主的混合性的组织学类型，则参与者有资格参与本研究。将根据主要细胞类型对混合肿瘤进行分类。
- 未接受过针对晚期或转移性非鳞状NSCLC的全身抗癌治疗。对于接受下述以外的辅助或新辅助治疗（包括ICI[如抗PD-1/PD-L1]或含铂治疗方案）的参与者，如果辅助/新辅助治疗的末次给药日期在本试验首次给药日期前至少6个月，且在辅助/新辅助治疗末次给药日期在内的6个月内未发生疾病进展，则此类参与者有资格参与本试验。 a.含靶向拓扑异构酶I化疗药物的任何药物，包括ADC。 b.基于抗体的HER2靶向抗癌治疗。
- 提供了足够的肿瘤组织样本（既往未经放疗）可供中心实验室或申办者指定的实验室评估HER2和PD-L1表达。如果无法提供参与者最近采集的存档肿瘤组织样本，则需要进行新鲜活检样本采集。有关肿瘤组织提交的详细信息请参见试验实验室手册。
排除标准
- 随机化/入组前6个月内存在心肌梗死或有症状的慢性心力衰竭（NYHA II级至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，QTc延长至>480 ms。
- 有需要类固醇治疗的（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。
- 患有与肺部相关的并发临床重大疾病，包括但不限于任何基础肺部疾病（例如，在试验随机化前3个月内出现的肺栓塞、重度哮喘、重度COPD、限制性肺疾病、胸腔积液等）。
- 既往行全肺切除术。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:DS8201 注射液
|
剂型:冻干粉剂
|
|
中文通用名:帕博利珠单抗
|
剂型:浓缩液
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:卡铂注射液
|
剂型:输注用浓溶液
|
|
中文通用名:卡铂注射液
|
剂型:输注用浓溶液
|
|
中文通用名:顺铂
|
剂型:输注用浓溶液
|
|
中文通用名:培美曲塞
|
剂型:输注用浓溶液
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| BICR评估的PFS | 从随机化日期至出现影像学疾病进展或全因死亡日期之间的时间间隔 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| OS | 从随机化日期至全因死亡日期之间的时间间隔。 | 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 | |
|---|---|---|---|---|---|---|---|
| 周彩存 | 博士 | 主任医师 | 13301825532 | caicunzhoudr@163.com | 上海市-上海市-浦东新区云台路1800号 | 200032 | 上海市东方医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 上海市东方医院 | 周彩存 | 中国 | 上海市 | 上海市 |
| 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 |
| 吉林省肿瘤医院 | 程颖 | 中国 | 吉林省 | 长春市 |
| 北京肿瘤医院 | 赵军 | 中国 | 北京市 | 北京市 |
| 中国医科大学附属第一医院 | 赵明芳 | 中国 | 辽宁省 | 沈阳市 |
| 湖北省肿瘤医院 | 杨彬 | 中国 | 湖北省 | 武汉市 |
| 南方医科大学南方医院 | 刘来昱 | 中国 | 广东省 | 广州市 |
| 湖南省肿瘤医院 | 邬麟 | 中国 | 湖南省 | 长沙市 |
| 南昌大学第二附属医院 | 刘安文 | 中国 | 江西省 | 南昌市 |
| 四川大学华西医院 | 周清华 | 中国 | 四川省 | 成都市 |
| 襄阳市中心医院 | 易铁男 | 中国 | 湖北省 | 襄阳市 |
| 内江市第二人民医院 | 刘宇 | 中国 | 四川省 | 内江市 |
| 重庆大学附属肿瘤医院 | 王恩文 | 中国 | 重庆市 | 重庆市 |
| 吉林大学第一医院 | 陈晓 | 中国 | 吉林省 | 长春市 |
| 中日友好医院 | 杨萌 | 中国 | 北京市 | 北京市 |
| 山西省肿瘤医院 | 宋霞 | 中国 | 山西省 | 太原市 |
| 山东省肿瘤医院 | 唐晓勇 | 中国 | 山东省 | 济南市 |
| 天津医科大学总医院 | 钟殿胜 | 中国 | 天津市 | 天津市 |
| 四川省肿瘤医院 | 李娟 | 中国 | 四川省 | 成都市 |
| 河南省肿瘤医院 | 王启鸣 | 中国 | 河南省 | 郑州市 |
| 华中科技大学同济医学院附属协和医院 | 董晓荣 | 中国 | 湖北省 | 武汉市 |
| 哈尔滨医科大学附属肿瘤医院 | 刘宝刚 | 中国 | 黑龙江省 | 哈尔滨市 |
| 安徽医科大学第二附属医院 | 刘红艳 | 中国 | 安徽省 | 合肥市 |
| 浙江大学医学院附属第一医院 | 周建娅 | 中国 | 浙江省 | 杭州市 |
| 西安交通大学第一附属医院 | 姚煜 | 中国 | 陕西省 | 西安市 |
| 浙江省肿瘤医院 | 金莹 | 中国 | 浙江省 | 杭州市 |
| 临沂市肿瘤医院 | 石建华 | 中国 | 山东省 | 临沂市 |
| 江苏省人民医院 | 郭人花 | 中国 | 江苏省 | 南京市 |
| 辽宁省肿瘤医院 | 刘宏旭 | 中国 | 辽宁省 | 沈阳市 |
| 南昌大学第一附属医院 | 李勇 | 中国 | 江西省 | 南昌市 |
| 华中科技大学同济医学院附属同济医院 | 褚倩 | 中国 | 湖北省 | 武汉市 |
| 安徽省立医院 | 章俊强 | 中国 | 安徽省 | 合肥市 |
| Hospital Universitario Austral | Manglio Rizzo, Miguel | Argentina | Buenos Aires | Pilar |
| Fundacion CENIT para la Investigacion en Neurociencias | Casalnuovo, Monica | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Centro de Investigacion Pergamino SA | Kahl, Susana | Argentina | Buenos Aires | Pergamino |
| Sanatorio Parque S.A. | Martinengo, Gaston | Argentina | Santa Fe | Rosario |
| CINME - Centro De Investigaciones Metabolicas | Rondinon, Monica | Argentina | Buenos Aires | CABA |
| Hospital Italiano de Buenos Aires | Ferreira, Yamila | Argentina | Buenos Aires | Ciudad Autonoma Buenos Aires |
| Instituto Medico de la Fundacion Estudios Clinicos | Garbaos, Gabriel | Argentina | Santa Fe | Rosario |
| Sanatorio Britanico S.A. | Tatangelo, Marcelo | Argentina | Santa Fe | Rosario |
| Instituto Medico Especializado Alexander Fleming | Martin, Claudio | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Instituto Argentino de Diagnostico y Tratamiento | Cundom, Juan Esteban | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Instituto de Oncologia de Rosario | Lucchesi Bosco, Lucas Emanuel | Argentina | Santa Fe | Rosario |
| Instituto de Investigaciones Metabolicas (IDIM) | Rapacciolli, Mara Daiana | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Instituto San Marcos | Aguero, Gabriel Alberto | Argentina | San Juan | San Juan |
| Instituto de Investigaciones Clinicas Cordoba S.A. | Castagneris, Nicolas | Argentina | Cordoba | Cordoba |
| CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE | Paulus, Astrid | Belgium | NA | Liege |
| CHU Helora-Hospital de Mons | Holbrechts, Stéphane | Belgium | NA | Mons |
| Les Viviers | Colinet, Benoit | Belgium | NA | Gilly |
| Chu Helora Hospital La Louvière Site Jolimont | Catala, Gaetan | Belgium | NA | La Louvière |
| UZA | Janssens, Annelies | Belgium | NA | Edegem |
| CRIO - Centro Regional Integrado de Oncologia | Cronemberger Costa e Silva, Eduardo Henrique | Brazil | Ceará | Fortaleza |
| Centro de Tratamento Oncologico (CTO) | Neto, Eduardo | Brazil | Sao Paulo | Ribeirao Preto |
| Centro Paulista de Oncologia S A | William Junior, William Nassib | Brazil | Sao Paulo | Vila Olímpia |
| Hospital Ernesto Dornelles | Santiago Escovar, Carlos Eugenio | Brazil | Rio Grande do Sul | Porto Alegre |
| Hospital Sao Lucas da PUCRS | Gelatti, Ana Caroline | Brazil | Rio Grande do Sul | Porto Alegre |
| ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira | Junior, Gilberto | Brazil | Sao Paulo | Sao Paulo |
| CIONC-Centro Integrado de Oncologia de Curitiba | Costa Maia Vianna, Karina | Brazil | Paraná | Curitiba |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Vaz de Melo Sette, Claudia | Brazil | Sao Paulo | Santo Andre |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Cardoso Guedes, Joao Daniel | Brazil | Sao Paulo | Sao Jose Rio Preto |
| Centro de Pesquisas Clinica Reichow | Reichow, Sandro Laercio | Brazil | Santa Catarina | Blumenau |
| Instituto D’Or Pesquisa e Ensino - Rio de Janeiro | da Rocha Baldotto, Clarissa | Brazil | Rio do Janeiro | Rio do Janeiro |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Ferreira da Silva, Flavio Augusto | Brazil | Sao Paulo | Barretos |
| Hospital das Clínicas FMRP-USP | Brito Silva, Saulo | Brazil | Sao Paulo | Ribeirao Preto |
| Hospital Nossa Senhora da Conceicao | de Menezes, Juliana Janoski | Brazil | Rio Grande do Sul | Porto Alegre |
| Oncoclínicas Rio de Janeiro | Xavier, Marina | Brazil | Rio de Janeiro | Rio de Janeiro |
| Obras Sociais Irma Dulce - Hospital Santo Antonio | Andrade, Livia Maria | Brazil | Bahia | Salvador |
| Liga Norte-Rio-Grandense Contra o Cancer | de Almeida Matias, Danielli | Brazil | Rio Grande do Norte | Natal |
| Centro de Investigacion Clinica Bradford Hill | Rojas Garcia, Carlos | Chile | NA | Santiago |
| Clinica Redsalud Vitacura | Miranda Olivares, Juan Pablo | Chile | NA | Santiago |
| Orlandi Oncologia | Orlandi, Francisco Javier | Chile | NA | Santiago |
| Biocenter | Rodriguez De Vasquez, Esther Mireya | Chile | NA | Concepcion |
| Centro de Oncologia de Precision, Universidad Mayor | Garrido Salvo, Marcelo Adan | Chile | NA | Santiago |
| Hospital Clinico Universidad de Chile | Barajas Barajas, Olga | Chile | NA | Santiago |
| Centre Hospitalier Intercommunal de Créteil | Chouaid, Christos | France | Val de Marne | Creteil Cedex |
| CHU Nantes - Hopital Guillaume et René Laennec | Pons Tostivint, Elvire | France | Loire Atlantique | Saint Herblain |
| Hopital Bichat - Claude Bernard | Zalcman, Gérard | France | Paris | Paris Cedex 18 |
| ICO - Site René Gauducheau | Raimbourg, Judith | France | Loire Atlantique | Saint Herblain |
| Centre Leon Berard | Perol, Maurice | France | Rhone | Lyon |
| Hopital Albert Calmette - CHU Lille | Cortot, Alexis | France | Nord | Lille Cedex |
| Institut Gustave Roussy | Besse, Benjamin | France | Val de Marne | Villejuif cedex |
| Hopital Privé du Confluent | Blonz, Cyriac | France | Loire Atlantique | Nantes cedex 2 |
| Hospices Civils de Lyon | Duruisseaux, Michael | France | Rhone | Bron cedex |
| CHU Angers - Hopital Larrey | Oulkhouir, Youssef | France | Maine et Loire | Angers Cedex 9 |
| Hopital Larrey | Mazieres, Julien | France | Haute Garonne | Toulouse |
| Centre Georges Francois Leclerc | Kaderbhai, Coureche | France | Cotes d'Armor | Dijon cedex |
| Assistance Publique-Hopitaux de Marseille | Tomasini, Pascale | France | Bouches-du-Rhone | Marseille |
| Clinique Clementville | Becht, Catherine | France | Herault | Montpellier |
| Hopital Tenon | Cadranel, Jacques | France | Paris | Paris |
| Hopital Ambroise Paré | Giroux Leprieur, Etienne | France | Hauts de Seine | Boulogne Billancourt |
| Institut Bergonié | Cousin, Sophie | France | Gironde | Bordeaux cedex |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Alt, Juergen | Germany | Rheinland Pfalz | Mainz |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Wehler, Thomas | Germany | Hessen | Giessen |
| Universitaetsmedizin Mannheim | Collienne, Maike | Germany | Baden Wuerttemberg | Mannheim |
| Universtitaetsklinikum Essen | Wiesweg, Marcel | Germany | Nordrhein Westfalen | Essen |
| Klinikum Esslingen GmbH | Faehling, Martin | Germany | Baden Wuerttemberg | Esslingen |
| Universitaetsklinikum Leipzig AoeR | Wirtz, Hubert | Germany | Sachsen | Leipzig |
| University General Hospital | Psyrri, Amanda | Greece | NA | Athens |
| Interbalkan Hospital of Thessaloniki | Korantzis, Ippokratis | Greece | NA | Thessaloniki |
| University General Hospital of Larissa | Kotsakis, Athanasios | Greece | NA | Larisa |
| St Luke's Hospital | Fountzila, Elena | Greece | NA | Thessaloniki |
| General Hospital of Athens of Chest Diseases | Syrigos, Konstantinos | Greece | NA | Athens |
| Special Anticancer Hospital of Piraeus | Fergadis, Evangelos | Greece | NA | Piraeus |
| Henry Dynant Hospital Center | Mountzios, Ioannis | Greece | NA | Athens |
| University Hospital of Patra | Koutras, Angelos | Greece | NA | Patras |
| Metropolitan Hospital | Linardou, Eleni | Greece | NA | Neo Faliro |
| General Hospital Papageorgiou | Timotheadou, Eleni | Greece | NA | Thessaloniki |
| Hong Kong United Oncology Centre | Li, Yu Chung | 中国香港 | Hong Kong | Jordan |
| The University of Hong Kong | Lee, Victor Ho Fun | 中国香港 | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Chik, Yin Kwan | 中国香港 | Hong Kong | Hong Kong |
| Hong Kong Integrated Oncology Centre | Chan, Oscar Siu Hong | 中国香港 | Hong Kong | Hong Kong |
| Gleneagles Hospital Hong Kong | Ngan, Roger Kai Cheong | 中国香港 | Hong Kong | Hong Kong |
| The Chinese University of Hong Kong | Loong, Herbert Ho Fung | 中国香港 | Hong Kong | Shatin |
| Deenanath Mangeshkar Hospital and Research Centre | Deshmukh, Chetan Dilip | India | Maharashtra | Pune |
| Yenepoya Medical College Hospital | Chatradi, Tejesh Krishna | India | Karnataka | Mangalore |
| Narayana Superspeciality Hospital | Agarwala, Vivek | India | West Bengal | Howrah |
| Tata Memorial Hospital | Noronha, Vanita | India | Maharashtra | Mumbai |
| Nirmal Hospital Private Limited | Agarwal, Anshul | India | Gujarat | Surat |
| Mazumdar Shaw Medical Center | Majumdar, Swaratika | India | Karnataka | Bangalore |
| All India Institute of Medical Sciences | Barik, Sandip Kumar | India | Orissa | Bhubaneswar |
| Humanitas Istituto Clinico Catanese | Russo, Alessandro | Italy | Catania | Misterbianco |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Gelsomino, Francesco | Italy | Bologna | Bologna |
| Istituto Nazionale Tumori Regina Elena IRCCS | Cappuzzo, Federico | Italy | Roma | Roma |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Bria, Emilio | Italy | Roma | Rome |
| Ospedale Santa Croce | Chiari, Rita | Italy | Pesaro | Urbino Fano |
| Centro Ricerche Cliniche di Verona s.r.l. | Pilotto, Sara | Italy | Verona | Verona |
| Istituto Nazionale per la Ricerca sul Cancro di Genova | Genova, Carlo | Italy | Genova | Genova |
| Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) | Grossi, Francesco | Italy | Varese | Varese |
| Azienda Ospedaliera S.Giovanni Addolorata | Lugini, Antonio | Italy | Roma | Rome |
| Ospedale San Raffaele | Ferrara, Roberto | Italy | Milano | Milano |
| Azienda Ospedaliero-Universitaria S.Luigi Gonzaga | Novello, Silvia | Italy | Torino | Orbassano |
| Presidio Ospedaliero di Livorno | Allegrini, Giacomo | Italy | Livorno | Livorno |
| Fondazione del Piemonte per l'Oncologia IRCCS Candiolo | Gregorc, Vanesa | Italy | Torino | Candiolo |
| Saiseikai Kumamoto Hospital | Kawamura, Kodai | Japan | Kumamoto-Ken | Kumamoto-shi |
| Ehime University Hospital | Yamamoto, Shoichiro | Japan | Ehime Ken | Toon shi |
| Matsusaka Municipal Hospital | Hataji, Osamu | Japan | Mie Ken | Matsusaka shi |
| Hospital of the University of Occupational and Environmental Health | Tanaka, Fumihiro | Japan | Fukuoka Ken | Kitakyushu shi |
| NHO Kinki-Chuo Chest Medical Center | Okishio, Kyoichi | Japan | Osaka Fu | Sakai shi |
| National Cancer Center Hospital East | Izumi, Hiroki | Japan | Chiba Ken | Kashiwa shi |
| Shizuoka Cancer Center | Ono, Akira | Japan | Shizuoka Ken | Sunto gun |
| Osaka International Cancer Institute | Inoue, Takako | Japan | Osaka Fu | Osaka shi |
| Tottori University Hospital | Sakamoto, Tomohiro | Japan | Tottori Ken | Yonago shi |
| Wakayama Medical University Hospital | Akamatsu, Hiroaki | Japan | Wakayama Ken | Wakayama shi |
| Hirosaki University Hospital | Tanaka, Hisashi | Japan | Aomori Ken | Hirosaki shi |
| Kansai Medical University Hospital | Kurata, Takayasu | Japan | Osaka Fu | Hirakata shi |
| Kanagawa Cancer Center | Katakura, Seigo | Japan | Kanagawa Ken | Yokohama shi |
| Keijinkai Teine Keijinkai Hospital | Yokoo, Keiki | Japan | Hokkaido | Sapporo shi |
| St. Marianna University Hospital | Furuya, Naoki | Japan | Kanagawa Ken | Kawasaki shi |
| Kurume University Hospital | Azuma, Koichi | Japan | Fukuoka Ken | Kurume shi |
| Fujita Health University Hospital | Imaizumi, Kazuyoshi | Japan | Aichi Ken | Toyoake shi |
| Tokyo Medical University Hospital | Takahashi, Satoshi | Japan | Tokyo To | Shinjuku ku |
| Osaka City General Hospital | Daga, Haruko | Japan | Osaka Fu | Osaka shi |
| Saitama Medical University International Medical Center | Imai, Hisao | Japan | Saitama Ken | Hidaka shi |
| Toho University Omori Medical Center | Kishi, Kazuma | Japan | Tokyo To | Ota ku |
| NHO Okayama Medical Center | Fujiwara, Keiichi | Japan | Okayama Ken | Okayama shi |
| Hospital Kuala Lumpur | Sulaiman Shah, Audi Adawiah | Malaysia | Kuala Lumpur | Kuala Lumpur |
| Hospital Tengku Ampuan Afzan | Ibrahim, Aishah | Malaysia | Pahang | Kuantan |
| Beacon Hospital Sdn Bhd | Tho, Lye Mun | Malaysia | Selangor | Petaling Jaya |
| Gleneagles Penang | Ong, Choo Khoon | Malaysia | Pulau Pinang | Jalan Pangkor |
| Hospital Civil Fray Antonio Alcalde | Vazquez Limon, Juan Carlos | Mexico | Jalisco | Guadalajara |
| Centro Medico Zambrano Hellion | Diaz Perez, Hector Marcelino | Mexico | Nuevo León | San Pedro Garza Garcia |
| Joaquin Gabriel Reinoso Toledo | Reinoso Toledo, Joaquin | Mexico | Nuevo León | Monterrey |
| Clinstile, S.A. de C.V. | Lara Mejia, Luis Antonio | Mexico | Distrito Federal | Ciudad de Mexico |
| Centro Potosino de Investigación Medica S.C. | Figueroa Martinez, Pedro | Mexico | San Luis Potos | San Luis Potosi |
| Pratia MCM Krakow | Drosik Kwasniewska, Anna | Poland | NA | Kraków |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie | Chmielewska, Izabela | Poland | NA | Lublin |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu | Kuc, Kamil | Poland | NA | Przemysl |
| Provita Prolife | Ciazynska, Magdalena | Poland | NA | Tomaszow Mazowiecki |
| Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente | Machado, Andrea | Portugal | NA | Lisboa |
| Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António | Araujo, Antonio | Portugal | NA | Porto |
| Hospital CUF Porto | Hespanhol, Venceslau | Portugal | NA | Porto |
| Hospital da Luz | Moreira Pinto, Joao | Portugal | NA | Lisboa |
| Institutul Oncologic | Muntean, Alina Simona | Romania | NA | Cluj Napoca |
| Memorial Healthcare International S R L | Iordan, Ingrid | Romania | NA | Bucharest |
| Spitalul Municipal Ploiesti | Nita, Amedeia | Romania | NA | Ploiesti |
| Spitalul Clinic Militar de Urgenta Dr. | Crisan, Georgeta | Romania | NA | Cluj Napoca |
| Centrul de Oncologie Sfantul Nectarie Craiova | Schenker, Michael | Romania | NA | Craiova |
| S.C R.T.C Radiology Therapeutic Center S.R.L | Ciubotaru, Elena | Romania | NA | Otopeni |
| Institutul Regional de Oncologie Iasi | Marinca, Mihai-Vasile | Romania | NA | Iasi |
| Colentina Hospital | Popescu, Andrei | Romania | NA | Bucureti |
| S.C Delta Health Care S.R.L | Craciunescu, Andrea | Romania | NA | Bucuresti |
| Severance Hospital, Yonsei University Health System | Cho, Byoung Chul | South Korea | NA | Seoul |
| The Catholic University of Korea, St. Vincent's Hospital | Shim, Byoung Yong | South Korea | Gyeonggi do | Suwon si |
| Seoul National University Bundang Hospital | Kim, Se Hyun | South Korea | Gyeonggi do | Seongnam |
| National Cancer Center | Han, Ji-Youn | South Korea | Gyeonggi do | Goyang si |
| Asan Medical Center | Kim, Sang-We | South Korea | NA | Seoul |
| Chungbuk National University Hospital | Lee, Ki Hyeong | South Korea | Chungcheongbuk do | Cheongju si |
| Samsung Medical Center | Lee, Se-Hoon | South Korea | NA | Seoul |
| Gyeongsang National University Hospital | Lee, Gyeong-Won | South Korea | Gyeongsangnam do | Jinju si |
| CHA Bundang Medical Center, CHA University | Kim, Joo-Hang | South Korea | Gyeonggi do | Seongnam si |
| Hospital Universitari Dexeus | Aguilar Hernandez, Andres | Spain | Barcelona | Barcelona |
| Hospital Regional Universitario de Malaga | Cobo Dols, Manuel | Spain | Málaga | Málaga |
| Hospital Universitario Clinico San Carlos | Antonanzas Basa, Monica | Spain | Madrid | Madrid |
| Hospital Clinic de Barcelona | Reguart Aransay, Noemi | Spain | Barcelona | Barcelona |
| Hospital Universitario Lucus Augusti | Vazquez Estevez, Sergio | Spain | Lugo | Lugo |
| Hospital Universitario Central de Asturias | Esteban Gonzalez, Emilio | Spain | Asturias | Oviedo |
| Hospital Universitario La Paz | de Castro, Javier | Spain | Madrid | Madrid |
| Complejo Hospitalario Universitario de Santiago | Leon Mateos, Luis Angel | Spain | La Coruna | Santiago de Compostela |
| Hospital del Mar | Arriola Aperribay, Edurne | Spain | Barcelona | Barcelona |
| Hospital Clinico Universitario Virgen de la Victoria | Benitez Montanez, Jose Carlos | Spain | Málaga | Malaga |
| Hospital Universitario Nuestra Senora de Valme | Fuentes Pradera, Jose | Spain | Sevilla | Sevilla |
| Hospital General Universitario Gregorio Maranon | Alvarez Alvarez, Rosa | Spain | Madrid | Madrid |
| Instituto Valenciano de Oncologia IVO | Sandiego Contreras, Sergio | Spain | Valencia | Valencia |
| Hospital Provincial de Castellon | Arnal Rondan, Maria | Spain | Castellón | Castellon |
| Complejo Asistencial Universitario de Burgos | Bayona Anton, Cristina | Spain | Burgos | Burgos |
| ICO l'Hospitalet - Hospital Duran i Reynals | Cuellar Rivas, Miler Andres | Spain | Barcelona | Barcelona |
| Complejo Hospitalario Universitario A Coruna | Garcia Campelo, Maria Rosario | Spain | La Coruna | La Coruna |
| Hospital Universitario 12 de Octubre | Zugazagoitia Fraile, Jon | Spain | Madrid | Madrid |
| Complejo Hospitalario Universitario Insular Materno-Infantil | Rodriguez Abreu, Delvys | Spain | Las Palmas | Las Palmas de Gran Canaria |
| Hospital Universitari Vall d'Hebron | Felip Font, Enriqueta | Spain | Barcelona | Barcelona |
| Tri-Service General Hospital | Tsai, Chen-Liang | 中国台湾 | Taiwan | Taipei |
| National Taiwan University Cancer Center | Yang, Chih-Hsin | 中国台湾 | Taiwan | Taipei |
| National Cheng Kung University Hospital | Lee, Chun-Hui | 中国台湾 | Taiwan | Tainan |
| Koo Foundation Sun Yat-Sen Cancer Center | Chen, Peng-Yu | 中国台湾 | Taiwan | Taipei |
| Taichung Veterans General Hospital | Yang, Tsung-Ying | 中国台湾 | Taiwan | Taichung |
| Chang Gung Memorial Hospital,Linkou | Kuo, Chih-Hsi | 中国台湾 | Taiwan | Taoyuan City |
| Chi Mei Hospital, Liouying | Hsiao, Sheng-Yen | 中国台湾 | Taiwan | Tainan |
| Taipei Veterans General Hospital | Luo, Yung-Hung | 中国台湾 | Taiwan | Taipei |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Hung, Jen-Yu | 中国台湾 | Taiwan | Kaohsiung |
| Chulabhorn Hospital | Ungtrakul, Teerapat | Thailand | Bangkok | Laksi |
| Rajavithi Hospital | Maneenil, Kunlatida | Thailand | Bangkok | Rajathevee |
| Siriraj Hospital | Danchaivijitr, Pongwut | Thailand | Bangkok | Bangkoknoi |
| Songklanagarind Hospital | Geater, Sarayut | Thailand | Songkhla | Hat Yai |
| Vajira Hospital | Runglodvatana, Yotsawaj | Thailand | Bangkok | Dusit |
| Phramongkutklao Hospital | Prasongsook, Naiyarat | Thailand | Bangkok | Bangkok |
| Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital | Durnali, Ayse | Turkey | NA | Ankara |
| GATA (Gulhane Military Medical School) | Erturk, Ismail | Turkey | NA | Ankara |
| Medical Park Seyhan Hospital | Sezer, Ahmet | Turkey | NA | Adana |
| Medipol University Medical Faculty | Olmez, Omer | Turkey | NA | Istanbul |
| Hacettepe University Medical Faculty | Erman, Mustafa | Turkey | NA | Ankara |
| I.E.ü. Medicalpoint Izmir Hastanesi | Arslan, Cagatay | Turkey | NA | Izmir |
| Cukurova University Medical Faculty | Sahin, Berksoy | Turkey | NA | Adana |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Gumus, Mahmut | Turkey | NA | Istanbul |
| Nottingham University Hospitals City Campus | Adhikaree, Jason | United Kingdom | Nottinghamshire | Nottingham |
| Altnagelvin Area Hospital | Bedair, Ahmed | United Kingdom | Derry | Londonderry |
| Eastbourne District General Hospital | Donovan, Victoria | United Kingdom | East Sussex | Eastbourne |
| Charing Cross Hospital | Evans, Joanne | United Kingdom | Greater London | London |
| Cheltenham General Hospital | Brown, Sean | United Kingdom | Gloucestershire | Cheltenham |
| Gabrail Cancer Center | Gabrail, Nashat | United States | Ohio | Canton |
| BRCR GLOBAL | Gandhi, Chintan | United States | Florida | Plantation |
| Providence Medical Foundation | Anderson, Ian | United States | California | Santa Rosa |
| California Research Institute | Al Jazayrly, Ghassan | United States | California | Los Angeles |
| Clinical Research Alliance | D Olimpio, James | United States | New York | Westbury |
| Holy Cross Hospital | Azzi, Georges | United States | Florida | Ft. Lauderdale |
| Alaska Oncology & Hematology, LLC | Liu, Steven | United States | Alaska | Anchorage |
| Karmanos Cancer Institute at Detroit | Mamdani, Hirva | United States | Michigan | Detroit |
| Cleveland Clinic Florida - Weston | Saravia, Diana | United States | Florida | Weston |
| St. Charles Health System | Tiffany, Natasha | United States | Oregon | Bend |
| University of Kansas Medical Center Research Institute, Inc. | Huang, Chao | United States | Kansas | Kansas City |
| Orange Coast Memorial Medical Center | Rao, Amol | United States | California | Fountain Valley |
| Los Angeles Cancer Network | Tang, Ronald | United States | California | Glendale |
| Summit Cancer Treatment Center | Chaudhry, Arvind | United States | Washington | Spokane |
| FirstHealth of the Carolinas, Inc. | Kuzma, Charles | United States | North Carolina | Pinehurst |
| The Queens Medical Center | Villanueva, Nicolas | United States | Hawaii | Honolulu |
| Lynn Cancer Institute Center | Kareff, Samuel | United States | Florida | Boca Raton |
| Dana-Farber Cancer Institute | Rotow, Julia | United States | Massachusetts | Boston |
| Logan Health Research | Anderes, Elise | United States | Montana | Kalispell |
| Lumi Research | Nguyen, David | United States | Texas | Houston |
| Mayo Clinic | Mansfield, Aaron | United States | Minnesota | Rochester |
| Community Network | Shukla, Nikhil | United States | Indiana | Indianapolis |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 上海市东方医院药物/器械临床试验伦理委员会 | 同意 | 2025-03-25 |
| 上海市东方医院药物/器械临床试验伦理委员会 | 同意 | 2025-06-24 |
试验状态信息
试验状态
进行中-招募中
目标入组人数
国内: 110 ；
国际: 686 ；
已入组例数
国内: 1 ；
国际: 1 ；
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：2025-09-23；
国际：2025-09-02；
第一例受试者入组日期
国内：2025-10-27；
国际：2025-10-27；
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 |
|---|
