北京VVD-133214片II期临床试验-一项旨在研究 VVD-133214 联合另一种抗癌药物帕博利珠单抗（pembrolizumab）在晚期结肠癌或直肠癌患者中疗效的临床试验

登记号	CTR20262977	试验状态	进行中
申请人联系人	临床试验信息公布组	首次公示信息日期	2026-07-31
申请人名称	拜耳医药保健有限公司

登记号	CTR20262977
相关登记号	暂无
药物名称	VVD-133214 片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	用于微卫星不稳定型（MSI）和/或错配修复缺陷型（dMMR）晚期结直肠癌患者的一线治疗
试验专业题目	一项在微卫星不稳定型（MSI）和/或错配修复缺陷（dMMR）晚期结直肠癌（CRC）参与者中比较VVD-133214联合帕博利珠单抗与帕博利珠单抗单药治疗的II期、随机、开放性研究
试验通俗题目	一项旨在研究 VVD-133214 联合另一种抗癌药物帕博利珠单抗（pembrolizumab）在晚期结肠癌或直肠癌患者中疗效的临床试验
试验方案编号	VVD-133214-02/23236	方案最新版本号	1.0
版本日期:	2026-02-20	方案是否为联合用药	是

申请人名称	[["拜耳医药保健有限公司"]]
联系人姓名	临床试验信息公布组	联系人座机	010-65360866	联系人手机号	18610155905
联系人Email	clinical-trials-contact@bayer.com	联系人邮政地址	北京市-北京市-北京市朝阳区东大桥路9号北京侨福芳草地大厦D座7层	联系人邮编	100020

主要目的：评价VVD-133214与帕博利珠单抗联合治疗与帕博利珠单抗单药治疗相比的有效性 次要目的：考察VVD-133214与帕博利珠单抗联合治疗的安全性和耐受性、确定VVD-133214与帕博利珠单抗联合治疗的RP2D、考察VVD-133214与帕博利珠单抗联合治疗的PK特征、评价VVD-133214与帕博利珠单抗联合治疗相比帕博利珠单抗单药治疗的抗肿瘤活性

试验分类	安全性和有效性	试验分期	II期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["签署知情同意书时年龄≥18岁"],["预期寿命≥12周"],["ECOG体能评分为0或1"],["根据当地SoC确认为MSI和/或dMMR肿瘤状态，经组织学或细胞学证实为晚期（不可切除和/或转移性）CRC"],["既往未接受过转移性疾病的全身性治疗，且不适宜接受根治性切除术"],["参与者必须在经认证的实验室有MSI和/或dMMR肿瘤状态的常规诊断检查记录"],["有甲醛固定石蜡包埋（FFPE）的存档肿瘤组织，以便提交给申办方/中心实验室开展回顾性中心检测，包括隐去部分信息的病理学报告副本（如有）"],["有符合RECIST第1.1版标准的可测量病灶"],["血液学和器官功能良好，研究治疗首次给药前14天内获得的实验室检查结果符合以下标准：n- 充分的血液学状态（中性粒细胞绝对计数≥1500/μL；血小板计数≥100,000/μL；血红蛋白≥9 g/dL；n-充分的肾功能，肌酐清除率≥50 mL/min（Cockcroft-Gault）n-充分的肝功能，总胆红素≤1.5×ULN，AST 和ALT≤2.5×ULN 。证实存在肝脏转移的参与者： AST 和ALT≤5×ULN。凝血：国际标准化比值（INR）、凝血酶原时间（PT）或活化部分凝血活酶时间（aPTT）≤1.5×ULN（接受抗凝治疗的参与者应在C1D1前接受稳定剂量治疗至少1周）"],["具有生育能力的女性在开始研究治疗前，必须进行血清妊娠试验且结果为阴性"]]
排除标准	[["既往接受过针对晚期CRC的全身性治疗。参与者既往可接受过辅助化疗，前提是辅助治疗末次给药后至少12个月后发生疾病进展。"],["既往接受过辅助免疫治疗（如抗PD-1药物、抗PD-L1药物、抗PD-L2药物、抗CTLA-4药物，或其他特异性靶向T细胞共刺激或免疫检查点通路的抗体或药物，包括既往接受过抗肿瘤疫苗或其他免疫刺激性抗肿瘤药物等）"],["已知存在活动性或未受控制的中枢神经系统（CNS）转移或脑部转移（正在进展，或需要抗惊厥药或皮质类固醇控制症状）和/或癌性脑膜炎"],["患有活动性自身免疫性疾病或免疫缺陷，或有其病史，且在过去2年内需要治疗。有自身免疫相关甲状腺功能减退症病史、且正在接受甲状腺激素替代治疗的参与者有资格参加研究；1型糖尿病得到控制、且正在接受胰岛素治疗的参与者有资格参加研究"],["筛选期前5年内有CRC以外的恶性肿瘤病史。以下除外：如已得到充分治疗的宫颈原位癌、黑色素瘤以外的皮肤癌、局限性前列腺癌Gleason评分<7级、浅表性膀胱癌、乳腺导管原位癌。林奇综合征参与者不被排除"],["研究治疗开始前2周内需要全身性免疫抑制药物治疗（如皮质类固醇），或预期在研究治疗期间需要全身性免疫抑制药物治疗，但以下情况除外：接受短期、低剂量全身性免疫抑制药物（如每日泼尼松等效剂量<10 mg）"],["根据当地诊断标准及当地法律法规进行的乙型肝炎病毒检测阳性（HBV阳性；定义为乙型肝炎表面抗原阳性和/或乙型肝炎核心抗体阳性）或丙型肝炎病毒检测阳性（HCV阳性；定义为HCV抗体或HCV RNA阳性），表明存在急性或慢性感染。丙型肝炎抗体阳性的参与者如果接受了完整疗程的根治性抗病毒治疗，且参加试验前至少两次HCV PCR检测结果呈阴性，则可能有资格参加研究。"],["已知患有Werner综合征的参与者"],["存在既往抗肿瘤治疗引起的治疗相关毒性、且在研究治疗前未恢复至≤1级（CTCAE），但以下情况除外：2级毒性：脱发、外周神经病变以及研究者和医学专员确定的无临床意义实验室检查结果变化"],["既往接受过任何WRN解旋酶抑制剂治疗"]]

试验药

[["中文通用名:VVD-133214 英文通用名:VVD-133214 商品名称:NA","剂型:片剂 规格:25mg 用法用量:150mgbid或600mgbid 用药时程:21天一个周期，直至疾病进展"],["中文通用名:VVD-133214 英文通用名:VVD-133214 商品名称:NA","剂型:片剂 规格:150mg 用法用量:150mgbid或600mgbid 用药时程:21天一个周期，直至疾病进展"],["中文通用名:VVD-133214 英文通用名:VVD-133214 商品名称:NA","剂型:片剂 规格:200mg 用法用量:150mgbid或600mgbid 用药时程:21天一个周期，直至疾病进展"],["中文通用名:帕博利珠单抗 英文通用名:Pembrolizumab 商品名称:可瑞达","剂型:注射液(浓溶液) 规格:100mg/4ml 用法用量:200mg 用药时程:每3周一次，最长2年"]] 序号 名称 用法

对照药

[["中文通用名:帕博利珠单抗 英文通用名:Pembrolizumab 商品名称:可瑞达","剂型:注射液(浓溶液) 规格:100mg/4ml 用法用量:200mg 用药时程:每3周一次，最长2年"]] 序号 名称 用法

主要终点指标及评价时间

[["研究者评估的6个月界标PFS率，定义为存活且根据RECIST第1.1版无疾病进展的参与者比例","从研究治疗开始到研究结束","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

[["根据NCI CTCAE第5.0版分级的不良事件发生率、性质和严重程度","VVD-133214末次给药后30天，帕博利珠单抗末次给药后100天","安全性指标"],["确定VVD-133214与帕博利珠单抗联合治疗的RP2D","安全性导入阶段结束","有效性指标+安全性指标"],["VVD-133214单次和多次给药后的Cmax","第1、2、3周期以及每两个周期","安全性指标"],["VVD-133214单次和多次给药后的Tmax","第1、2、3周期以及每两个周期","安全性指标"],["VVD-133214单次和多次给药后的AUC","第1、2、3周期以及每两个周期","安全性指标"],["研究者根据RECIST第1.1版评估的ORR","从研究治疗开始到研究结束","有效性指标"],["研究者根据RECIST第1.1版评估的DCR","从研究治疗开始到研究结束","有效性指标"],["研究者根据RECIST第1.1版评估的DOR","从研究治疗开始到研究结束","有效性指标"],["研究者根据RECIST第1.1版评估的mPFS","从研究治疗开始到研究结束","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	沈琳	学位	博士	职称	主任医师
	电话	010-88196561	Email	doctorshenlin@sina.cn	邮政地址	北京市-北京市-北京市海淀区阜成路52号北京肿瘤医院消化肿瘤内科
	邮编	100142	单位名称	北京大学肿瘤医院

[["北京大学肿瘤医院","沈琳","中国","北京市","北京市"],["中山大学附属第六医院","邓艳红","中国","广东省","广州市"],["浙江大学医学院附属邵逸夫医院","郑宇","中国","浙江省","杭州市"],["华中科技大学同济医学院附属同济医院","袁响林","中国","湖北省","武汉市"],["复旦大学附属中山医院","刘天舒","中国","上海市","上海市"],["四川大学华西医院","邱萌","中国","四川省","成都市"],["山东省肿瘤医院","牛作兴","中国","山东省","济南市"],["福建省肿瘤医院","陈奕贵","中国","福建省","福州市"],["哈尔滨医科大学附属肿瘤医院","王广雨","中国","黑龙江省","哈尔滨市"],["蚌埠医科大学第一附属医院","高振远","中国","安徽省","蚌埠市"],["浙江大学附属肿瘤医院","韩卫东","中国","浙江省","杭州市"],["云南省肿瘤医院","谢琳","中国","云南省","昆明市"],["Fundación Intecnus","Andres Anton","阿根廷","内格罗河省","巴里洛切"],["Investigaciones Oncológicas C Colón","Griselda Del Valle Manfredini","阿根廷","布宜诺斯艾利斯","布宜诺斯艾利斯"],["Instituto Alexander Fleming","Federico Esteso","阿根廷","布宜诺斯艾利斯","布宜诺斯艾利斯"],["Centro Medico Fleischer","Guillermo Mendez","阿根廷","布宜诺斯艾利斯","布宜诺斯艾利斯"],["Sanatorio Allende | Departamento de Investigación Clínica","Stefano Kim","阿根廷","科尔多瓦","科尔多瓦"],["Hospital Italiano de Buenos Aires","Maria Alicia Verzura","阿根廷","布宜诺斯艾利斯","布宜诺斯艾利斯"],["Sanatorio Parque - Oncology","Federico Barichello","阿根廷","圣菲省","罗萨里奥"],["UZ Leuven - Digestive oncology","Gertjan Rasschaert","比利时","弗拉芒布拉班特","鲁汶"],["institut jules bordet - clinique d'oncology","Francesco Sclafani","比利时","布鲁塞尔","布鲁塞尔"],["AZ Delta - Digestive oncology","Sofie De Meulder","比利时","鲁瑟拉勒","鲁瑟拉勒"],["CHU Helora - Oncology department","Pierre Florent PETIT","比利时","拉卢维耶尔","拉卢维耶尔"],["UZ Gent - Digestive Oncology","Karen Geboes","比利时","根特","根特"],["NAIC - Instituto do Cancer","Marcelo Bernardini Antunes","巴西","圣保罗州","包鲁"],["Hospital Evangélico de Cachoeiro de Itapemirim","Sabina Bandeira Aleixo","巴西","圣埃斯皮里图州","维多利亚"],["Instituto do Cancer do Estado de Sao Paulo","Marilia Silva","巴西","圣保罗州","圣保罗"],["Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí","Edilson Walter","巴西","南里奥格兰德州","伊茹伊"],["Hospital Sirio Libanes - Oncology_Sao Paulo","Fernanda Capareli","巴西","圣保罗州","圣保罗"],["Fundacao Pio XII - Hospital de Cancer de Barretos","Gustavo Pinto","巴西","圣保罗州","雅乌"],["Hospital Araujo Jorge Associacao de Combate ao Cancer em Goias","Adriano Paula","巴西","戈亚斯州","戈亚尼亚"],["Unidade de Pesquisas Clinicas em Oncologia","Marcio Costa","巴西","南里奥格兰德州","佩洛塔斯"],["Asklepios Klinik Altona - Onkologie, Hamatologie, Palliativmedizin, Rheumatologie und Pneumologie","Dirk Arnold","德国","汉堡","汉堡"],["Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)","Thorsten Oliver Goetze","德国","黑森州","法兰克福"],["Universitatsklinikum Ulm - Klinik für Innere Medizin I","Thomas Seufferlein","德国","巴登-符腾堡州","乌尔姆"],["Klinikum Oldenburg - Klinik für Onkologie und Hamatologie","Andrea Renzelmann","德国","下萨克森州","奥尔登堡"],["Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)","Stefan Kasper-Virchow","德国","北莱茵-威斯特法伦州","埃森"],["Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2","Stephan Kanzler","德国","巴伐利亚州","施韦因富特"],["DRK Kliniken Berlin-Kopenick - Darmzentrum","Patrick Stübs","德国","柏林","柏林"],["Hospital Universitario Ramon Y Cajal | Oncologia Medica","Maria Reyes Ferreiro Monteagudo","西班牙","马德里","马德里"],["Complexo Hospitalario Universitario De Santiago | Oncologia","Yolanda Vidal Insua","西班牙","拉科鲁尼亚","圣地亚哥-德孔波斯特拉"],["Hospital Clinico Universitario De Valencia | Oncologia","Susana Rosello Keranen","西班牙","瓦伦西亚","瓦伦西亚"],["Hospital Universitario Virgen De La Victoria | Oncologia Medica","Laura Medina Rodríguez","西班牙","马拉加","马拉加"],["Hospital Universitari Vall D Hebron | Oncologia","Javier Ros Montana","西班牙","巴塞罗那","巴塞罗那"],["Hospital del Mar | Oncologia","Marta Guix Arnau","西班牙","巴塞罗那","巴塞罗那"],["CHU Brest - Hopital La Cavale Blanche - service oncologie medicale","Jean Philippe Metges","法国","布列塔尼","布雷斯特"],["Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale","Christelle Fontaniere De La Fouchardiere","法国","马赛","马赛"],["Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale","Francois Ghiringhelli","法国","第戎","第戎"],["CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology","Christophe BORG","法国","贝桑松","贝桑松"],["University Hospitals Coventry and Warwickshire NHS Trust","Vanessa Potter","英国","西米德兰兹","考文垂"],["University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit","Kai-Keen Shiu","英国","伦敦","伦敦"],["General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A","Michalis Liontos","希腊","阿提卡","雅典"],["Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic","Evangelos Bournakis","希腊","阿提卡","雅典"],["Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology","Ippokratis Korantzis","希腊","塞萨洛尼基","皮莱亚"],["Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department","Alexandros Ardavanis","希腊","阿提卡","雅典"],["General University Hospital Of Patras- Division of Oncology, Department of Medicine","Angelos Koutras","希腊","西希腊","帕特雷"],["Laiko General Hospital Of Athens- Oncology Department","Dimitrios ZIOGAS","希腊","阿提卡","雅典"],["Prince of Wales Hospital","Brigette Ma","中国香港","新界","沙田"],["Queen Mary Hospital","Thomas C.C. YAU","中国香港","南区","薄扶林"],["Hong Kong United Oncology Centre","Jacky Yu Chung Li","中国香港","九龙","九龙"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica","Lisa Salvatore","意大利","罗马","罗马"],["ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck","Andrea Sartore Bianchi","意大利","米兰","米兰"],["Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative","Giuseppe Curigliano","意大利","米兰","米兰"],["A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia","Fortunato Ciardiello","意大利","那不勒斯","那不勒斯"],["Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia","Alberto Puccini","意大利","罗扎诺","罗扎诺"],["Severance Hospital | Oncology","Sang Joon Shin","韩国","首尔","首尔"],["Seoul National University Bundang Hospital | Oncology","Keun-Wook Lee","韩国","首尔","首尔"],["Seoul National University Hospital | Oncology","Sae-Won Han","韩国","首尔","首尔"],["Asan Medical Center | Oncology","Jeong Eun Kim","韩国","首尔","首尔"],["Samsung Medical Center | Oncology","Seung Tae Kim","韩国","首尔","首尔"],["Instituto Nacional de Cancerología","Maria del Consuelo Diaz Romero","墨西哥","墨西哥城","墨西哥城"],["Oncare Viaducto Nápoles","Jeronimo Rodriguez","墨西哥","墨西哥城","墨西哥城"],["Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia","Alejandro De Leon","墨西哥","新莱昂州","蒙特雷"],["Onkimia: Clinica Oncologica Especializada en Guadalajara","Miguel Fuentes","墨西哥","瓜达拉哈拉","胡安·曼努埃尔"],["Grupo Medico ASSET S.C","Josue Mora Perez","墨西哥","墨西哥城","墨西哥城"],["Hospital Zambrano Hellion","Hector Marcelino Diaz-Perez","墨西哥","新莱昂州","蒙特雷"],["Hospital Umum Sarawak (Sarawak General Hospital) SGH","Pei Jye Voon","马来西亚","砂拉越","古晋"],["Cengild G.I. Medical Centre - Curie Oncology KL","Gwo Fuang Ho","马来西亚","吉隆坡","吉隆坡"],["Universiti Malaya Medical Centre - Clinical Oncology Department","Po Lin Ooi","马来西亚","吉隆坡","吉隆坡"],["Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy","Nurul Atiqah Mat Nasukhat","马来西亚","沙巴","亚庇"],["Sunway Medical Centre - Medical Oncology","Vance Yung Chean Koi","马来西亚","雪兰莪","梳邦再也"],["Sunway Medical Centre Penang - Department of Clinical Oncology","Kean Fatt Ho","马来西亚","槟城","北赖"],["HagaZiekenhuis - Oncologie Interne Geneeskunde","Vincent de Weger","荷兰","海牙","海牙"],["Comarch Healthcare SA Centrum Medyczne iMed24","Pawel Potocki","波兰","克拉科夫","克拉科夫"],["Narodowy Instytut Onkologii im. Marii Skiodowskiej Curie Państwowy Instytut Badawczy- Oddziai Warszawa Wawelska","Lucjan Wyrwicz","波兰","华沙","华沙"],["Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddziai Onkologii Klinicznej i Radioterapii","Marta Czeluscinska Murawiec","波兰","谢德尔采","谢德尔采"],["Biaiostockie Centrum Onkologii im. M. Skiodowskiej-Curie w Biaiymstoku Oddziai Onkologii Klinicznej","Piotr Tokajuk","波兰","比亚韦斯托克","比亚韦斯托克"],["Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddziai Onkologiczny z Pododdziaiem Dziennej Chemioterapii","Kamil Kuc","波兰","普热梅希尔","普热梅希尔"],["Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika wlodzi","Maja Lisik-Habib","波兰","罗兹","罗兹"],["Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina","Cezary Szczylik","波兰","奥特沃茨克","奥特沃茨克"],["PRATIA MCM KRAKóW","Anna Drosik-Kwasniewska","波兰","克拉科夫","克拉科夫"],["Centrum Medyczne Pratia Poznan","Marek Kotlarski","波兰","斯科热沃","斯科热沃"],["Pratia Wroclaw","Jacek Calik","波兰","弗罗茨瓦夫","弗罗茨瓦夫"],["Opolskie Centrum Onkologii","Barbara Radecka","波兰","奥波莱","奥波莱"],["Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Servi？o de Oncologia Médica","Catia Gaspar","葡萄牙","波尔图","波尔图"],["START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon","Andre Mansinho","葡萄牙","里斯本","里斯本"],["Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Servico de Oncologia","Edgar Pratas","葡萄牙","英布拉","英布拉"],["Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Servico de Oncologia Médica","Isália Miguel","葡萄牙","里斯本","里斯本"],["Unidade Local de Saúde de Sao José, E.P.E - Hospital dos Capuchos - Servico de Oncologia Médica","Joao Gramaca","葡萄牙","里斯本","里斯本"],["National Cancer Center Singapore - Oncology Department","Si-Lin Koo","新加坡","新加坡","新加坡"],["National University Cancer Institute (NCIS)","Hui Jia Gloria Chan","新加坡","新加坡","新加坡"],["OncoCare Cancer Centre | Gleneagles Medical Centre","Angela Pang","新加坡","新加坡","新加坡"],["Curie Oncology | Farrer","Su Pin Choo","新加坡","新加坡","新加坡"],["Istanbul Medeniyet üniversitesi Goztepe Süleyman Yacin Sehir Hastanesi","Mahmut Gumus","土耳其","伊斯坦布尔","卡德柯伊"],["Ankara Bilkent Sehir Hastanesi","Mehmet Sendur","土耳其","安卡拉","比尔肯特·昌卡亚"],["Ankara Etlik Sehir Hastanesi","Berna Oksuzoglu","土耳其","安卡拉","耶尼马哈莱"],["Trakya Univ. Tip Fak.","Muhammed Bekir Hacioglu","土耳其","埃迪尔内","埃迪尔内"],["Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology","Nedim Turan","土耳其","伊斯坦布尔","伊斯坦布尔"],["VM Medical Park Samsun Hospital Medical Oncology Department","Dilek Erdem","土耳其","萨姆松","萨姆松"],["Gaziantep Sehir Hastanesi -Medical Oncology Department","Hakan Buyukhatipoglu","土耳其","加济安泰普","加济安泰普"],["National Cheng Kung University Hospital","Yu-Min Yeh","中国台湾","台南","台南"],["Chang Gung Memorial Hospital Kaohsiung","Yu-Li Su","中国台湾","高雄","高雄"],["Chang Gung Memorial Hospital at Linkou","Hung-Chih Hsu","中国台湾","台北","台北"],["Taipei Veterans General Hospital","Hao-Wei Teng","中国台湾","台北","台北"],["Chi Mei Medical Center, Yongkang Branch","Yu-Hsuan Kuo","中国台湾","台南","台南"],["Taichung Veterans General Hospital | Division of Colorectal Surgery","Feng-Fan Chiang","中国台湾","台中","台中"],["Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology","Pei-Hung Chang","中国台湾","基隆","基隆"],["University of Arizona Cancer Center - North Campus","Aaron Scott","美国","亚利桑那州","图森"],["Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit","Zaid Al-Saheli","美国","密歇根州","底特律"],["Mary Babb Randolph Cancer Center","Meghana Singh","美国","西弗吉尼亚州","摩根敦"]]

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","2026-07-21"]]

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: 13 ； 国际: 140 ；
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；