登记号
CTR20170061
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
未接受过治疗的局部晚期或转移性尿路上皮癌
试验通俗题目
在尿路上皮癌患者中比较Atezolizumab和含铂化疗联合治疗的研究
试验专业题目
在未治疗的局部晚期或转移性尿路上皮癌患者中比较Atezolizumab和含铂化疗联合治疗的多中心、随机、安慰剂对照、III 期研究
试验方案编号
WO30070
方案最近版本号
V9
版本日期
2021-03-09
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
丁侃
联系人座机
021-28923049
联系人手机号
联系人Email
stella.ding@roche.com
联系人邮政地址
上海市-上海市-龙东大道1100号11号楼3楼
联系人邮编
201203
临床试验信息
试验分类
有效性
试验分期
III期
试验目的
这是一项III 期、多中心、随机、安慰剂对照、部分设盲研究， 旨在评价Atezolizumab 单药治疗或与含铂化疗联合治疗对比安慰剂与含铂化疗联合治疗在既往未接受全身治疗的局部晚期或转移性尿路上皮癌患者中的有效性。
随机化
随机化
盲法
双盲
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
无岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 签署知情同意
- 年龄≥18 岁
- 研究者认为患者适合接受含铂化疗
- ECOG 体能状态评分≤2
- 根据研究者的判断患者能够遵循研究方案
- 组织学证实的局部晚期或转移性尿路上皮癌
- 在入选研究前，为集中检测和确定肿瘤标本是否可进行肿瘤PD-L1 表达评价，患者需有代表性的福尔马林固定石蜡包埋肿瘤标本或至少15块未染色的肿瘤组织切片，以及相关的病理报告。
- 既往对于不能手术的局部晚期或转移性尿路上皮癌未使用化疗
- 按实体瘤疗效评价标准第1.1 版，具有可测量疾病
- 足够的血液学和终末器官功能，按下述实验室检查结果定义，这些检查结果需在首次接受治疗前28天内获得。
- 中性粒细胞绝对计数≥1500 个细胞/μL
- 白细胞（WBC）计数> 2500 个细胞/μL
- 淋巴细胞计数≥ 300 个细胞/μL
- 血小板计数≥100,000 个细胞/μL
- 血红蛋白≥ 9.0 g/dL
- 天冬氨酸氨基转移酶、丙氨酸氨基转移酶和碱性磷酸酶≤2.5 × 正常上限（ULN）
- 血清胆红素≤ 1.5 × ULN
- 肌酐清除率≥30mL/min
- 血清钙≤3 mmol/L
- 对于育龄期妇女：同意在治疗期间以及末剂卡铂、顺铂、或吉西他滨给药后至少6 个月或者末剂Atezolizumab 给药后至少5 个月内保持禁欲（避免异性性交）或采取年失败率<1%的避孕措施
- 对于男性：同意禁欲（避免异性性交）或采取避孕措施，并同意避免捐精。
排除标准
- 开始研究治疗前3 周内接受任何已批准的抗癌治疗（包括化疗或激素疗法）
- 入组前28 天内，接受了其他试验药物治疗或参与其他治疗目的的临床研究
- 筛选期和影像学评估前，经计算机断层扫描（CT）或核磁共振成像（MRI）检测发现活动性或未治疗的CNS 转移灶
- 软脑膜疾病
- 未控制的胸腔积液、心包积液，或需要反复引流的腹水（每月一次或更频繁）
- 未控制的肿瘤相关疼痛
- 未控制的高钙血症
- 第1 疗程第1 天前5 年内患有尿路上皮癌以外的其他恶性肿瘤
- 预期寿命<12 周
- 处于妊娠期、哺乳期或计划在研究期间怀孕
- 血清白蛋白< 25 g/L
- 对嵌合或人源化抗体或融合蛋白有严重过敏、过敏反应或其他超敏反应病史
- 已知对由中国仓鼠卵巢细胞生产的生物药品或Atezolizumab 制剂任何成分过敏或有超敏反应
- 自身免疫性疾病病史，包括但不限于重症肌无力、肌炎、自身免疫性肝炎、系统性红斑狼疮、类风湿性关节炎、炎性肠病、抗磷脂综合征相关的血管血栓形成、Wegener's 肉芽肿病、干燥综合征、格林－巴利综合征、多发性硬化、血管炎、肾小球肾炎等。
- 既往接受过异体干细胞移植或实体器官移植的患者
- 有特发性肺纤维化病史（包括肺炎）、药物诱导性肺炎病史、机化性肺炎病史（即，闭塞性细支气管炎，隐源性机化性肺炎），或筛选期胸部CT 扫描发现活动性肺炎证据
- 重大心血管疾病，如纽约心脏病学会定义的心脏疾病（III 级或更高）、随机分配前3月内发生的心肌梗塞、不稳定型心律失常、不稳定型心绞痛
- 左心室射血分数（LVEF）< 40%
- HIV 检测结果呈阳性
- 活动性乙型肝炎（定义为筛选期乙肝病毒表面抗原[HBsAg]检测结果阳性）或丙型肝炎
- 活动性肺结核
- 随机入组前4 周内发生重度感染，包括但不限于因感染、菌血症或重度肺炎等并发症而入院治疗的情况。
- 随机入组前2 周内接受口服或静脉途径的抗生素治疗
- 随机分配前4 周内接受过大型手术，或预期将在研究期间接受大型手术（以诊断为目的的手术除外）
- 在第1 疗程第1 天前4 周内使用了减毒活疫苗
- 任何其它疾病、代谢障碍、体格检查结果或临床实验室检查异常结果，并有理由怀疑可能导致禁忌使用试验药物、或影响研究结果可靠性、或使患者处于高风险的治疗并发症的疾病或病症
- 既往接受过CD137 激动剂、抗CTLA-4、抗PD-1 或抗PD-L1 治疗性抗体或信号通路靶向药物治疗
- 在第1 疗程第1 天前4 周内或药物5 个半衰期内（以短者为准）接受过全身免疫刺激剂治疗（包括但不限于干扰素或白介素-2）
- 第1 疗程第1 天前2 周内接受过全身性皮质类固醇或其他全身免疫抑制药物（包括但不限于泼尼松、地塞米松、环磷酰胺、硫唑嘌呤、甲氨喋呤、沙利度胺、抗肿瘤坏死因子[TNF] 制剂），或者预期在研究期间需要使用全身免疫抑制药物
- 已知对吉西他滨存在超敏反应史
- 存在严重的顺铂、或其它含铂化合物过敏反应史
- 重度骨髓抑制或严重出血
- 顺铂禁用于既存肾功能损害的患者。骨髓抑制或听力受损患者不应使用顺铂
- 顺铂禁用于存在顺铂或其他含铂化合物过敏反应史的患者
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:Atezolizumab注射液
|
用法用量:注射液；规格1200mg/20ml；静脉注射，每3周一次，每次1200mg，治疗将持续直到失去临床获益、不可耐受的毒性、患者或医生决定中止治疗、或接受试验治疗的患者死亡。
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂注射液
|
用法用量:注射液；规格1200mg/20ml；静脉注射，每3周一次，每次1200mg，用药时程：直至研究者按实体瘤疗效评价标准第1.1 版判定患者出现疾病进展或不可耐受的毒性反应。
|
|
中文通用名:吉西他滨注射液 英文名：Gemcitabine 商品名：健择
|
用法用量:注射液；规格 200mg；静脉注射，起始剂量为1000 mg/m2，在每个21天疗程的第1 天和第8 天经静脉输注给药，用药时程：直至研究者按实体瘤疗效评价标准第1.1 版判定患者出现疾病进展或不可耐受的毒性反应。
|
|
中文通用名:卡铂注射液 英文名：Carboplatin 商品名：伯尔定
|
用法用量:注射液；规格 150mg/15ml；静脉注射，将计算卡铂的起始剂量，以使得AUC 达到4.5，在每个21 天疗程的第1 天经静脉输注给药，用药时程：直至研究者按实体瘤疗效评价标准第1.1 版判定患者出现疾病进展或不可耐受的毒性反应。
|
|
中文通用名:顺铂注射液 英文名：Cisplatin 商品名：顺铂
|
用法用量:注射液；规格 50mg/50ml；静脉注射，顺铂的起始剂量为70mg/m2，在每个21 天疗程的第1 天经静脉输注给药，用药时程：直至研究者按实体瘤疗效评价标准第1.1 版判定患者出现疾病进展或不可耐受的毒性反应。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 研究者按照RECIST v1.1 评估的无进展生存期和总生存期。 | 44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 |
|---|---|---|
| 客观缓解率，缓解持续时间，Atezolizumab 单药治疗患者对比安慰剂+含铂化疗患者中研究者评估的无进展生存期，1 年OS 率，1 年PFS 率，根据欧洲癌症研究和治疗组织（EORTC）生活质量调查问卷核心30（QLQ-C30）测 量的至总体健康状态恶化的时间和EORTC QLQ-C30 测定的身体机能恶化的时间。 | 44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
无
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 叶定伟 | 医学博士 | 主任医师 | 13701663571 | dwyeli@163.com | 上海市-上海市-东安路270号 | 200032 | 复旦大学附属肿瘤医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 复旦大学附属肿瘤医院 | 叶定伟 | 中国 | 上海市 | 上海市 |
| 首都医科大学附属北京友谊医院 | 田野 | 中国 | 北京市 | 北京市 |
| 中山大学孙逸仙纪念医院 | 黄健 | 中国 | 广东省 | 广州市 |
| 江苏省肿瘤医院 | 邹青 | 中国 | 江苏省 | 南京市 |
| 复旦大学附属中山医院 | 郭剑明 | 中国 | 上海市 | 上海市 |
| 中国医学科学院北京协和医院 | 纪志刚 | 中国 | 北京市 | 北京市 |
| 重庆肿瘤医院 | 罗宏 | 中国 | 重庆市 | 重庆市 |
| 上海华东医院 | 孙忠全 | 中国 | 上海市 | 上海市 |
| Ashford Cancer Center Research | FRANCIS PARNIS | AUSTRALIA | South Australia | Kurralta Park |
| Box Hill Hospital | Ian Davis | AUSTRALIA | Victoria | Box Hill |
| CABRINI MEDICAL CENTRE; ONCOLOGY | JEREMY SHAPIRO | AUSTRALIA | Victoria | MALVERN |
| Macquarie University Hospital | HOWARD GURNEY | AUSTRALIA | New South Wales | Macquarie University |
| Royal Women Hospital | Aneta Suder | AUSTRALIA | Queensland | Herston |
| Sunshine Hospital Oncology Research | Shirley Wong | AUSTRALIA | Victoria | St Albans |
| Macquarie University Hospital | HOWARD GURNEY | AUSTRALIA | New South Wales | Westmead |
| AZ Sint Lucas (Sint Lucas) | Vincent Renard | BELGIUM | GENT | GENT |
| CHC MontLégia | Marie-Pascale Graas | BELGIUM | Liege | Liege |
| GHdC Site Notre Dame | Marco Gizzi | BELGIUM | Charleroi | Charleroi |
| UZ Leuven Gasthuisberg | Herlinde Dumez | BELGIUM | Leuven | Leuven |
| Clinic of Oncology University Clinical Center | Timur Ceric | BOSNIA | SARAJEVO | SARAJEVO |
| University Clinical Centre | SASA JUNGIC | BOSNIA | BANJA LUKA | BANJA LUKA |
| CETUS Hospital Dia Oncologia | Bruno Aragao | BRAZIL | MG | Belo Horizonte |
| Clinica de Neoplasias Litoral | Giuliano Borges | BRAZIL | SC | Itajai |
| Clinicas Oncologicas Integradas | Monica Padoan | BRAZIL | RJ | Rio de Janeiro |
| Clinica Viver | Luis Antunes | BRAZIL | RS | SANTA MARIA |
| Hospital das Clinicas | Rodrigo Pereira | BRAZIL | RS | Porto Alegre |
| Hospital de Base de Sao Jose do Rio Preto | Gustavo Girotto | BRAZIL | SP | Sao Jose do Rio Preto |
| Hospital de Caridade de Ijui Oncologia | Fabio Andre Franke | BRAZIL | RS | Ijui |
| Hospital Nossa Senhora da Conceicao | Carlos Gorini | BRAZIL | RS | Porto Alegre |
| Hospital Sao Lucas - PUCRS | Andre Fay | BRAZIL | RS | Porto Alegre |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | Diogo Bastos | BRAZIL | SP | Sao Paulo |
| Cross Cancer Institute | SCOTT NORTH | CANADA | Alberta | EDMONTON |
| Dr. Léon-Richard Oncology Centre | ALI BENJELLOUN | CANADA | New Brunswick | Moncton |
| Juravinski Cancer Clinic Clinical Trials Department | SOM MUKHERJEE | CANADA | Ontario | HAMILTON |
| Lakeridge Health Center R. S. MacLaughlin Durham Regional Cancer Center | Pawel Zalewski | CANADA | Ontario | OSHAWA |
| NORTH YORK GENERAL HOSPITAL | Danny Robson | CANADA | Ontario | TORONTO |
| Tom Baker Cancer Centre-Calgary Clinical Research Unit | Nimira Alimohamed | CANADA | Alberta | Calgary |
| Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas | Mauricio Burotto | CHILE | RECOLETA | RECOLETA |
| Health & Care SPA | FRANSCICO ORLANDI | CHILE | NE | Grand Island |
| Clinica Alemana | Claudio Salas | CHILE | Vitacura | Vitacura |
| Fundacion Arturo Lopez Perez | PAMELA SALMAN | CHILE | Santiago | Santiago |
| Masarykuv onkologicky ustav | Alexandr Poprach | CZECH REPUBLIC | Toscana | PISA |
| University Hospital Motol Department of Urology | Marek Babjuk | CZECH REPUBLIC | Praha 5 | Praha 5 |
| Vseobecna fakultni nemocnice v Praze | Milada Zemanova | CZECH REPUBLIC | PRAHA 2 | PRAHA 2 |
| East Tallinn Central Hospital | Kristiina Ojamaa | ESTONIA | Tallinn | Tallinn |
| North Estonia Medical Centre Foundation; Oncology Center | Helis Pokker | ESTONIA | Tallinn | Tallinn |
| OULU UNIVERSITY HOSPITAL ONCOLOGY | Minna Jaaskeluinen | FINLAND | OULU | OULU |
| TURKU UNI CENTRAL HOSPITAL; ONCOLOGY CLINICS | Johanna Ruohola | FINLAND | Turku | Turku |
| Chemotherapy Clinic | Giorgi Adeishvili | GEORGIA | Tbilisi | Tbilisi |
| National Center of Urology | Ambrosi Pertia | GEORGIA | TBILISI | TBILISI |
| Research institute for Clinical Medicine | Zaal Kvirikashvili | GEORGIA | Tbilisi | Tbilisi |
| Alexandras General Hospital of Athens Oncology Department | Aristotelis Bamias | GREECE | Athens | Athens |
| UNIVERSITY HOSPITAL OF PATRAS MEDICAL ONCOLOGY | HARALABOS KALOFONOS | GREECE | Patras | Patras |
| PRINCESS MARGARET HOSPITAL ONCOLOGY | CHI KIN CHENG | 中国香港 | HONG KONG | HONG KONG |
| QUEEN ELIZABETH HOSPITAL CLINICAL ONCOLOGY | Ho Ching Lam | 中国香港 | HONG KONG | HONG KONG |
| QUEEN MARY HOSPITAL DEPT OF CLINICAL ONCOLOGY | Steven Siu | 中国香港 | HONG KONG | HONG KONG |
| The Chinese University of Hong Kong Department of Clinical Oncology | Darren Poon | 中国香港 | HONG KONG | HONG KONG |
| Rambam Health Care Campus Oncology | Avivit Peer | ISRAEL | Haifa | Haifa |
| A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2 | MARIO AIROLDI | ITALY | Piemonte | TORINO |
| A.O. Universitaria Policlinico Di Modena; Oncologia | Roberto Sabbatini | ITALY | Emilia-Romagna | MODENA |
| ASST DI CREMONA; Dip. Medicina - S.C. Oncologia | RODOLFO PASSALACQUA | ITALY | Lombardia | CREMONA |
| Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico | Ferdinando Riccardi | ITALY | Campania | Napoli |
| Azienda Ospedaliera S. Maria - Terni; Oncologia | Claudia Caserta | ITALY | Umbria | Terni |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Alketa Hamzaj | ITALY | Toscana | Arezzo |
| IRCCS ISTITUTO NAZIONALE DEI TUMORI (INT);S.C. MEDICINA ONCOLOGICA 2 | Andrea Necchi | ITALY | Lombardia | MILANO |
| IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima | Umberto Basso | ITALY | Veneto | PADOVA |
| IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia | Franco Morelli | ITALY | Puglia | SAN GIOVANNI ROTONDO |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Ugo De Giorgi | ITALY | Emilia-Romagna | Meldola |
| ISTITUTO CLINICO HUMANITAS;U.O. ONCOLOGIA MEDICA ED EMATOLOGIA | Paolo Zucali | ITALY | Lombardia | ROZZANO |
| Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | ENRICO CORTESI | ITALY | Lazio | ROMA |
| Gunma University Hospital | Kazuhiro Suzuki | JAPAN | Gunma | Gunma |
| Hirosaki University Hospital | Yasuhiro Hashimoto | JAPAN | Aomori | Aomori |
| Kanazawa University Hospital | Kouji Izumi | JAPAN | Ishikawa | Ishikawa |
| Keio University Hospital | Ryuichi Mizuno | JAPAN | Tokyo | Tokyo |
| Kindai University Hospital | Kazuhiro Yoshimura | JAPAN | Osaka | Osaka |
| Kumamoto University Hospital | Takahiro Yamaguchi | JAPAN | Kumamoto | Kumamoto |
| Nagoya University Hospital | Takashi Fujita | JAPAN | Aichi | Aichi |
| National Hospital Organization Hokkaido Cancer Center | Satoshi Nagamori | JAPAN | Hokkaido | Hokkaido |
| National Hospital Organization Shikoku Cancer Center | Katsuyoshi Hashine | JAPAN | Ehime | Ehime |
| Niigata University Medical & Dental Hospital | Yoshihiko Tomita | JAPAN | Niigata | Niigata |
| Osaka City University Hospital | Satoshi Tamada | JAPAN | Osaka | Osaka |
| The Cancer Institute Hospital, JFCR; Urology | Junji Yonese | JAPAN | Tokyo | Tokyo |
| Toranomon Hospital | Yuji Miura | JAPAN | Tokyo | Tokyo |
| University of Tsukuba Hospital | Tomokazu Kimura | JAPAN | Ibaraki | Ibaraki |
| Gachon University Gil Medical Center | YoungSaing Kim | KOREA, REPUBLIC OF | Incheon | Incheon |
| Korea University Anam Hospital | Kyong Hwa Park | KOREA, REPUBLIC OF | Seoul | Seoul |
| Kyungpook National University Medical Center | JONG GWANG KIM | KOREA, REPUBLIC OF | Daegu | Daegu |
| Samsung Medical Center | Se Hoon Park | KOREA, REPUBLIC OF | Seoul | Seoul |
| Seoul National University Hospital | Bhumsuk Keam | KOREA, REPUBLIC OF | Seoul | Seoul |
| Severance Hospital, Yonsei University Health System | Sang-Joon Shin | KOREA, REPUBLIC OF | Seoul | Seoul |
| Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi | Muthukkumaran Thiagarajan | MALAYSIA | Kuala Lumpur | Kuala Lumpur |
| University Malaya Medical Centre; Clinical Oncology Unit, | Marniza Saad | MALAYSIA | Kuala Lumpur | Kuala Lumpur |
| Cancerología | ADRIANA DOMINGUEZ | MEXICO | QUERETARO | Queretaro |
| Consultorio Médico | José Arturo Rodríguez | MEXICO | Zapopan, Jalisco | Zapopan, Jalisco |
| Health Pharma Professional Research | Perla Perez | MEXICO | MEXICO CITY (FEDERAL DISTRICT) | CD Mexico |
| Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey | Jorge Luis Martinez Rodriguez | MEXICO | Monterrey, N.L | Monterrey, N.L |
| IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología | Noel Amaro | MEXICO | Ciudad de México DF | Ciudad de México DF |
| Hagaziekenhuis, locatie Leyweg | Danny Houtsma | NETHERLANDS | NL -DEN HAAG | NL -DEN HAAG |
| Zuyderland Medisch Centrum; Internal Diseases | Franchette Van Den Berkmortel | NETHERLANDS | Sittard-Geleen | Sittard-Geleen |
| Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | MAREK WOJTUKIEWICZ | POLAND | BIALYSTOK | BIALYSTOK |
| NU-MED Centrum Diagnostyki i Terapii Onkologicznej | EWA CHMIELOWSKA | POLAND | Tomaszów Mazowiecki | Tomaszów Mazowiecki |
| Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu | PIOTR TOMCZAK | POLAND | Poznan | Poznan |
| Przychodnia Lekarska KOMED, Roman Karaszewski | Bogus？awa Karaszewska | POLAND | Konin | Konin |
| Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o. | Iwona Skoneczna | POLAND | Warszawa | Warszawa |
| Szpital Uniwersytecki w Krakowie, Oddzia？ Kliniczny Kliniki Onkologii | Piotr Wysocki | POLAND | Kraków | Kraków |
| Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii | Piotr Potemski | POLAND | Lodz | Lodz |
| Hospital de Santa Maria; Servico de Oncologia Medica | Isabel Fernandes | PORTUGAL | LISBOA | LISBOA |
| IPO do Porto; Servico de Oncologia Medica | Nuno Sousa | PORTUGAL | PORTO | PORTO |
| Institute Of Oncology Bucharest; Medical Oncology | Dana Lucia Stanculeanu | ROMANIA | Bucharest | Bucharest |
| Oncology Center Sf. Nectarie | Michael Schenker | ROMANIA | Craiova | Craiova |
| Spitalul Judetean de Urgenta Dr Constantin Opris | Amalia Alina Herzal | ROMANIA | Baia Mare | Baia Mare |
| ALTAI REGIONAL ONCOLOGICAL CENTER; | Sergey Varlamov | RUSSIAN FEDERATION | BARNAUL | BARNAUL |
| BLOKHIN CANCER RESEARCH CENTER; UROLOGICAL DEPT | Vsevolod Matveev | RUSSIAN FEDERATION | MOSCOW | MOSCOW |
| Ivanovo Regional Oncology Dispensary | Andrey Semenov | RUSSIAN FEDERATION | Ivanovo | Ivanovo |
| Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Ruslan Zukov | RUSSIAN FEDERATION | Krasnoyarsk | Krasnoyarsk |
| P.A. HERZEN ONCOLOGICAL INST. ; ONCOLOGY | Boris Alekseev | RUSSIAN FEDERATION | MOSCOW | MOSCOW |
| PRIVOLZHSK REGIONAL MEDICAL CENTER | Vagif Atduev | RUSSIAN FEDERATION | NIZHNY NOVGOROD | NIZHNY NOVGOROD |
| Russian Scientific Center of Roentgenoradiology | Rustem Gafanov | RUSSIAN FEDERATION | Moscow | Moscow |
| SBEI HPE | Salman Al-Shukri | RUSSIAN FEDERATION | ST PETERSBURG | ST PETERSBURG |
| SBEI of HPE “Bashkir State Medical University” of MoH RF | Adel Izmaylov | RUSSIAN FEDERATION | Ufa | Ufa |
| Scientific Research Oncology Institute named after N.N. Petrov; Oncology | Alexander Nosov | RUSSIAN FEDERATION | St. Petersburg | St. Petersburg |
| Sverdlovsk Regional Clinical Hospital 1 | Dmitry Tevs | RUSSIAN FEDERATION | EKATERINBURG | EKATERINBURG |
| Clinical Center of Serbia; Clinic of Urology | Zoran Dzamic | SERBIA | BELGRADE | BELGRADE |
| Clinical Centre Nis, Clinic for Oncology | Vesna Stojanovic | SERBIA | NIs | NIs |
| Oncology Institute of Vojvodina | Lazar Popovic | SERBIA | Sremska Kamenica | Sremska Kamenica |
| NATIONAL CANCER CENTRE; MEDICAL ONCOLOGY | Ravindran Kanesvaran | SINGAPORE | Singapore | Singapore |
| National University Hospital; National University Cancer Institute, Singapore (NCIS) | Alvin Wong | SINGAPORE | Singapore | Singapore |
| Oncocare Cancer Centre; Gleneagles Medical Centre | MIAH HIANG TAY | SINGAPORE | Singapore | Singapore |
| INSTITUTE OF ONCOLOGY LJUBLJANA | Marina Mencinger | SLOVENIA | LJUBLJANA | LJUBLJANA |
| Cancercare | Jorn Malan | SOUTH AFRICA | Port Elizabeth | Port Elizabeth |
| Sandton Oncology Medical Group | Sze Chan | SOUTH AFRICA | Sandton | Sandton |
| Steve Biko Academic Hospital; Oncology | LYDIA DREOSTI | SOUTH AFRICA | Pretoria | Pretoria |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Daniel Castellano | SPAIN | Toscana | PISA |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Pablo Maroto Rey | SPAIN | Toscana | PISA |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Jose Luis Perez Gracia | SPAIN | NAVARRA | PAMPLONA |
| Complejo Asistencial Universitario De Burgos; Servicio de Oncologia | Guillermo Crespo Herrero | SPAIN | BURGOS | Burgos |
| Complejo Asistencial Universitario de Leon; Servicio de Oncologia | Angel Rodríguez Sánchez | SPAIN | LEON | LEON |
| Complejo Hospitalario de Althaia; Servicio de Oncologia | Montserrat Domenech Santasusana | SPAIN | BARCELONA | MANRESA |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Esther Martínez | SPAIN | JAEN | JAEN |
| Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Iciar Garcia Carbonero | SPAIN | TOLEDO | TOLEDO |
| Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia | Esther Nogueron Martinez | SPAIN | ALBACETE | ALBACETE |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Enrique Gallardo Diaz | SPAIN | BARCELONA | Sabadell |
| Hospital Alvaro Cunqueiro | Emilio Martin Lazaro Quintela | SPAIN | PONTEVEDRA | Vigo |
| Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department | Bego？a Mellado Gonzalez | SPAIN | BARCELONA | Barcelona |
| Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia | Eduardo Pujol | SPAIN | ZARAGOZA | Zaragoza |
| Hospital de Basurto; Servicio de Oncologia | Teresa Abad Villar | SPAIN | VIZCAYA | BILBAO |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Pablo Maroto Rey | SPAIN | BARCELONA | Barcelona |
| Hospital General Universitario de Elche; Servicio de Oncologia | Federico Vazquez Mazon | SPAIN | ALICANTE | ELCHE |
| Hospital General Universitario Gregorio Mara？on; Servicio de Oncologia | Jose Angel Arranz Arija | SPAIN | MADRID | Madrid |
| Hospital Juan Ramon Jimenez;Servicio de Oncologia | Francisco Jose Alvarez Marquez | SPAIN | HUELVA | HUELVA |
| Hospital Provincial de Castellon; Servicio de Oncologia | Alfredo Sanchez Hernandez | SPAIN | CASTELLON | CASTELLON |
| Hospital Ramon y Cajal; Servicio de Oncologia | Pablo Gajate Borau | SPAIN | MADRID | Madrid |
| Hospital San Pedro De Alcantara; Servicio de Oncologia | Ricardo Collado Martin | SPAIN | CACERES | Caceres |
| HOSPITAL UNIVERSITARIO SON ESPASES | Maria del Carmen Garcias de Espa？a | SPAIN | ISLAS BALEARES | PALMA DE MALLORCA |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Albert Font Pous | SPAIN | BARCELONA | Barcelona |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Daniel Castellano | SPAIN | MADRID | MADRID |
| Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Javier Puente Vazquez | SPAIN | MADRID | MADRID |
| Hospital Universitario la Fe; Servicio de Oncologia | Regina Girones Sarrio | SPAIN | VALENCIA | VALENCIA |
| Hospital Universitario La Paz; Servicio de Oncologia | Alvaro Pinto Marin | SPAIN | MADRID | MADRID |
| Hospital Universitario Lucus Augusti | Sergio Vazquez Estevez | SPAIN | LUGO | LUGO |
| Hospital Universitario Marques de Valdecilla; Servicio de OncologiaHospital Universitario Marques de Valdecilla; Servicio de Oncologia | Marta Lopez-Brea Piqueras | SPAIN | CANTABRIA | SANTANDER |
| Hospital Universitario Miguel Servet; Servicio de Oncologia Medica | M. Del Carmen Santander Lobera | SPAIN | ZARAGOZA | ZARAGOZA |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Ma JOSE MENDEZ | SPAIN | CORDOBA | CORDOBA |
| HOSPITAL UNIVERSITARIO SON ESPASES | Maria del Carmen Garcias de Espafla | SPAIN | ISLAS BALEARES | Palma De Mallorca |
| Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Raquel Luque Caro | SPAIN | GRANADA | GRANADA |
| Hospital Universitario Servicio Oncologia | Bega Perez Valderrama | SPAIN | SEVILLA | SEVILLA |
| Hospital Univ Vall Servicio de Oncologia | Rafael Morales Barrera | SPAIN | BARCELONA | BARCELONA |
| Institutio Catalan De Oncologia | Xavier Garcia del Muro | SPAIN | BARCELONA | BARCELONA |
| Chang Gung Medical Foundation - Kaohsiung; Oncology | Yu-Li Su | 中国台湾 | Kaohisung | Kaohisung |
| Chang Gung Medical Foundation-Linkou, Urinary Oncology | Cheng-Keng | 中国台湾 | TAOYUAN | TAOYUAN |
| China Medical University Hospital; Urology | Su-Peng Yeh | 中国台湾 | Taichung | Taichung |
| NATIONAL UNI HOSPITAL | Wen-Pin Su | 中国台湾 | TAINAN | TAINAN |
| NATIONAL TAIWAN UNI HOSPITAL; DEPT OF ONCOLOGY | Yu-Chieh Tsai | 中国台湾 | Taipei City | Taipei City |
| TAICHUNG VETERANS GENERAL HOSPITAL; DIVISION OF UROLOGY | Jian-Ri Li | 中国台湾 | TAICHUNG | TAICHUNG |
| CHULALONGKORN HOSPITAL; MEDICAL ONCOLOGY | VIROTE SRIURANPONG | THAILAND | BANGKOK | BANGKOK |
| FACULTY OF MED ONCOLOGY | Pongwut Danchaivijitr | THAILAND | BANGKOK | BANGKOK |
| Maharaj Nakorn Chiang Mai Hospital; Department of Medicine | Chaiyut Charoentum | THAILAND | ChiangMai | ChiangMai |
| Vajira Hospital | Yotsawaj Runglodvatana | THAILAND | Dusit | Dusit |
| RAMATHIBODI HOSPITAL | Phichai Chansriwong | THAILAND | BANGKOK | BANGKOK |
| Medical Faculty; Medical Oncology Department | Bahiddin lmaz | TURKEY | samsun | samsun |
| Ankara City Hospital | Mehmet Ali Nahit Sendur | TURKEY | Ankara | Ankara |
| Research Hospital Medical Oncology | Fatih Kose | TURKEY | ADANA | ADANA |
| University Medical School; Oncology | Hac Mehmet Turk | TURKEY | Istanbul | Istanbul |
| UNI MEDICAL FACULTY HOSPITAL | Mustafa Erman | TURKEY | ANKARA | ANKARA |
| Medical Oncology Department | MUSTAFA OZGUROGLU | TURKEY | ISTANBUL | ISTANBUL |
| Diseases Research Hospital | Mahmut Gumus | TURKEY | ISTANBUL | ISTANBUL |
| Medical Park Hospital | Cagatay Arslan | TURKEY | Kar？yaka | Kar？yaka |
| Medical Onology Hospital | Irfan Cicin | TURKEY | Edirne | Edirne |
| Oncology Disease Hospital | IGOR BONDARENKO | UKRAINE | Dnipropetrovsk | Dnipropetrovsk |
| Regional Clinical Center | Igor Antonyan | UKRAINE | GOVERNORATE | Kharkiv |
| BEATSON WEST OF SCOTLAND CANCER CENTRE | Robert Jones | UNITED KINGDOM | GLASGOW | GLASGOW |
| The York Hospital | Joji Joseph | UNITED KINGDOM | York | York |
| University College London Hospitals NHS Foundation Trust - University College Hospital | Ursula McGovern | UNITED KINGDOM | London | London |
| Bon Secours - St. Francis Hospital | Stephen Dyar | UNITED STATES | SC | Greenville |
| Christina Care Institutional Review Board | MICHAEL GUARINO | UNITED STATES | DE | Newark |
| Coastal Integrative Cancer Care | Thomas John Spillane | UNITED STATES | CA | San Luis Obispo |
| COMPREHENSIVE CANCER CENTERS OF NEVADA | Nicholas Vogelzang | UNITED STATES | NV | LAS VEGAS |
| East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion | Thomas Cosgriff | UNITED STATES | LA | METAIRIE |
| Florida Cancer Specialists; Department of Oncology | James Reeves | UNITED STATES | FL | Fort Myers |
| Florida Cancer Specialists (St. Petersburg – St. Anthony’s Professional Building) | LUCIO GORDAN | UNITED STATES | FL | Saint Petersburg |
| Highlands Oncology Group | J. Thaddeus Beck | UNITED STATES | AR | ROGERS |
| Moffitt Cancer Center; GME Office | Jingsong Zhang | UNITED STATES | FL | Tampa |
| Mount Sinai School of Medicine - Tisch Cancer Institute | Matthew Galsky | UNITED STATES | NY | New York |
| Norton Cancer Institute | Chandler Park | UNITED STATES | KY | Louisville |
| Norwalk Hospital | Richard Frank | UNITED STATES | CT | Norwalk |
| Park Nicollet Clin-Cancer Ctr | Rachel Lerner | UNITED STATES | MN | ST LOUIS PARK |
| Parkview Research Center | Zhentao Zhang | UNITED STATES | IN | Fort Wayne |
| Sarah Cannon Cancer Center | Johanna Bendell | UNITED STATES | TN | NASHVILLE |
| The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology | Peter Donnell | UNITED STATES | IL | Chicago |
| UF Health Cancer Center at Orlando Health | Daniel Landau | UNITED STATES | FL | Orlando |
| University of North Carolina, Lineberger Cancer Ctr | Matthew Milowsky | UNITED STATES | NC | Chapel Hill |
| Yale School of Medicine | Daniel Petrylak | UNITED STATES | CT | New Haven |
| 天津医科大学附属第二医院 | 牛远杰 | 中国 | 天津市 | 天津市 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 江苏省肿瘤医院伦理委员会 | 同意 | 2016-12-29 |
| 复旦大学附属肿瘤医院医学伦理委员会 | 同意 | 2020-06-02 |
| 复旦大学附属肿瘤医院医学伦理委员会 | 同意 | 2022-07-20 |
试验状态信息
试验状态
进行中-招募完成
目标入组人数
国内: 240 ；
国际: 1200 ；
已入组例数
国内: 40 ；
国际: 1214 ；
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：2017-06-28；
国际：2016-06-23；
第一例受试者入组日期
国内：2017-07-15；
国际：2016-06-27；
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 |
|---|
