上海SAR439859片III期临床试验-Amcenestrant（SAR439859）+哌柏西利作为ER（+）HER2（-）晚期乳腺癌患者的一线治疗（AMEERA-5）
上海复旦大学附属肿瘤医院开展的SAR439859片III期临床试验信息，需要患者受试者,主要适应症为ER（+）HER2（-）晚期乳腺癌
| 登记号 | CTR20210218 | 试验状态 | 进行中 |
|---|---|---|---|
| 申请人联系人 | 赛诺菲 | 首次公示信息日期 | 2021-02-03 |
| 申请人名称 | Sanofi-aventis recherche & développement/ PATHEON FRANCE-BOURGOIN JALLIEU/ Fisher Clinical Services Inc.;Creapharm Clinical Supplies;Sanofi US Services Inc.;Sanofi-aventis Recherche & Développement/ 赛诺菲（中国）投资有限公司 | ||
一、题目和背景信息
| 登记号 | CTR20210218 | ||
|---|---|---|---|
| 相关登记号 | 暂无 | ||
| 药物名称 | SAR439859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 | ER（+）HER2（-）晚期乳腺癌 | ||
| 试验专业题目 | 一项比较amcenestrant（SAR439859） +哌柏西利与来曲唑+哌柏西利治疗在复发转移阶段未接受过全身性抗癌治疗的ER（+）、HER2（-）晚期乳腺癌患者的随机、多中心、双盲、III期研究 | ||
| 试验通俗题目 | Amcenestrant（SAR439859）+哌柏西利作为ER（+）HER2（-）晚期乳腺癌患者的一线治疗（AMEERA-5） | ||
| 试验方案编号 | EFC15935 | 方案最新版本号 | 修订版临床试验方案03 |
| 版本日期: | 2020-12-16 | 方案是否为联合用药 | 否 |
二、申请人信息
| 申请人名称 |
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| 联系人姓名 | 赛诺菲 | 联系人座机 | 021-22266666 | 联系人手机号 | |
| 联系人Email | Contact-US.CN@sanofi.com | 联系人邮政地址 | 上海市-上海市-静安区延安中路1228号静安嘉里中心办公楼3座17楼中国临床研究中心 | 联系人邮编 | 200040 |
三、临床试验信息
1、试验目的
主要目的：确定与来曲唑联合哌柏西利相比，amcenestrantSAR439859联合哌柏西利是否可以改善在复发转移阶段未接受过全身性抗癌治疗的ER+HER2-晚期乳腺癌受试者的无进展生存期（PFS）。次要目的：比较两个治疗组的总生存期（OS）；评价两个治疗组的客观缓解率（ORR）；评价两个治疗组的缓解持续时间（DOR）；评价两个治疗组的临床获益率（CBR）；评价下一线治疗的无进展生存期（PFS2）；评价amcenestrantSAR439859、戈舍瑞林和哌柏西利的药代动力学（PK）; 评价两个治疗组的健康相关生活质量（HRQL）; 评价两个治疗组至首次化疗的时间; 评价两个治疗组的安全性” 2、试验设计
| 试验分类 | 安全性和有效性 | 试验分期 | III期 | 设计类型 | 平行分组 |
|---|---|---|---|---|---|
| 随机化 | 随机化 | 盲法 | 双盲 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 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 |
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| 排除标准 |
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4、试验分组
| 试验药 |
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| 对照药 |
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5、终点指标
| 主要终点指标及评价时间 |
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| 次要终点指标及评价时间 |
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四、研究者信息
1、主要研究者信息
| 1 | 姓名 | 邵志敏 | 学位 | 医学博士 | 职称 | 主任医师 |
|---|---|---|---|---|---|---|
| 电话 | 021-64175590-88603 | szmgcp2016@163.com | 邮政地址 | 上海市-上海市-上海市东安路270号 | ||
| 邮编 | 200032 | 单位名称 | 复旦大学附属肿瘤医院 | |||
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家 | 省（州） | 城市 |
|---|---|---|---|---|---|
| 1 | 复旦大学附属肿瘤医院 | 邵志敏 | 中国 | 上海市 | 上海市 |
| 2 | 浙江大学医学院附属邵逸夫医院 | 王娴 | 中国 | 浙江省 | 杭州市 |
| 3 | 吉林大学第一医院 | 李薇 | 中国 | 吉林省 | 长春市 |
| 4 | 吉林省肿瘤医院 | 程颖 | 中国 | 吉林省 | 长春市 |
| 5 | 浙江省肿瘤医院 | 王晓稼 | 中国 | 浙江省 | 杭州市 |
| 6 | 浙江大学医学院附属第一医院 | 傅佩芬 | 中国 | 浙江省 | 杭州市 |
| 7 | 浙江大学医学院附属第二医院 | 黄建 | 中国 | 浙江省 | 杭州市 |
| 8 | 北京肿瘤医院 | 李惠平 | 中国 | 北京市 | 北京市 |
| 9 | 哈尔滨医科大学附属肿瘤医院 | 张清媛 | 中国 | 黑龙江省 | 哈尔滨市 |
| 10 | 四川大学华西医院 | 罗婷 | 中国 | 四川省 | 成都市 |
| 11 | 苏州大学附属第二医院 | 庄志祥 | 中国 | 江苏省 | 苏州市 |
| 12 | 临沂市肿瘤医院 | 王京芬 | 中国 | 山东省 | 临沂市 |
| 13 | 济南市中心医院 | 孙美丽 | 中国 | 山东省 | 济南市 |
| 14 | 重庆大学附属肿瘤医院 | 曾晓华 | 中国 | 重庆市 | 重庆市 |
| 15 | 安徽省立医院 | 潘跃银 | 中国 | 安徽省 | 合肥市 |
| 16 | 大连医科大学附属第二医院 | 李曼 | 中国 | 辽宁省 | 大连市 |
| 17 | 河南省肿瘤医院 | 闫敏 | 中国 | 河南省 | 郑州市 |
| 18 | 湖北省肿瘤医院 | 吴新红 | 中国 | 湖北省 | 武汉市 |
| 19 | 广东省人民医院 | 廖宁 | 中国 | 广东省 | 广州市 |
| 20 | 徐州市中心医院 | 孙三元 | 中国 | 江苏省 | 徐州市 |
| 21 | 天津市肿瘤医院 | 张瑾 | 中国 | 天津市 | 天津市 |
| 22 | Instituto de Investigaciones Metabólicas IDIM | Cundom Juan | ARGENTINA | AR-B | CABA |
| 23 | Breast Cancer Research Centre | CHAN ARLENE | AUSTRALIA | VIC | Richmond |
| 24 | Epworth Healthcare | JENNENS Ross | AUSTRALIA | NSW | Wahroonga |
| 25 | Sydney Adventist Hospital | Marx Gavin | AUSTRALIA | NSW | Macquarie Park |
| 26 | Macquarie University | Sabanathan Dhanusha | AUSTRALIA | NSW | Macquarie Park |
| 27 | Prince Of Wales Hospital | FRIEDLANDER Michael | AUSTRIA | NSW | Randwick |
| 28 | Universitatsklinikum Graz | Petru Edgar | BELGIUM | NA | Graz |
| 29 | UZ Leuven | Neven Patrick | BELGIUM | NA | Leuven |
| 30 | CHU UCL Namur | Taylor donatienne | BELGIUM | NA | Namur |
| 31 | Clinques Universitaires Saint-Luc | Duhoux Francois | BELGIUM | NA | Bruxelles |
| 32 | Grand Hospital de Charleroi Site Notre Dame | Canon Jean-Luc | BELGIUM | NA | Charleroi |
| 33 | Hospital De Caridade De Ijui | Franke Fabio Andre | BRAZIL | BR-RS | Ijui |
| 34 | Instituto Brasileiro De Controle Do Cancer - IBCC | Cruz Felipe | BRAZIL | BR-SP | Sao Paulo |
| 35 | Instituto Nacional de Cancer - José Alencar Gomes da Silva | BINES Jose | BRAZIL | BR-RJ | Rio De Janeiro |
| 36 | Hospital De Clinicas De Porto Alegre | Liedke Pedro | BRAZIL | BR-RS | Porto Alegre |
| 37 | Hospital Nossa Senhora da Conceicao | Pedrini José Luiz | BRAZIL | BR-RS | Porto Alegre |
| 38 | Fundacao Antonio Prudente - Hospital A.C. Camargo | Pondé Noam | BRAZIL | BR-SP | Sao Paulo |
| 39 | REDE D′OR SAO LUIZ S.A. | Testa Laura | BRAZIL | BR-SP | Sao Paulo |
| 40 | Sunnybrook Research Institute | Warner Ellen | CANADA | CA-ON | Toronto |
| 41 | London Regional Cancer Program | Fernandes Ricardo | CANADA | CA-ON | London |
| 42 | Kingston General Hospital | Mates Mihaela | CANADA | CA-ON | Kingston |
| 43 | McGill University Health Centre - Glen Site - Centre for Innovative Medicine | Asselah Jamil | CANADA | CA-QC | Montreal |
| 44 | Moncton Hospital | Harb Mohammed | CANADA | CA-NB | Moncton |
| 45 | Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre (CISSSMC) | Soldera Sara | CANADA | CA-QC | Greenfield Park |
| 46 | Ste-Mary's Hospital | Esfahani Khashayar | CANADA | CA-QC | Montreal |
| 47 | Cape Breton Cancer Centre | Saliba Wissam | CANADA | CA-NS | Sydney |
| 48 | Cape Breton Cancer Centre | Khodadad Kian | CANADA | CA-NS | Sydney |
| 49 | Jewish General Hospital | Ferrario Cristiano | CANADA | CA-QC | Montreal |
| 50 | ONCOCENTRO APYS | Acevedo Alejandro | CHILE | CL-VS | Via del Mar |
| 51 | Centro de Investigacion Clinica Bradford Hill | Rojas Carlos | CHILE | CL-RM | Santiago |
| 52 | Centro de Investigacion Clinica Bradford Hill | Burotto Mauricio | CHILE | CL-RM | Santiago |
| 53 | Centro de Investigación de la universidad Catolica | SANCHEZ CESAR | CHILE | NA | Santiago de Chile |
| 54 | Sociedad de Investigaciones medicas LTDA | Yanez Patricio | CHILE | CL-AR | Temuco |
| 55 | IC La Serena Research | Morales Luisa | CHILE | CL-CO | La Serena |
| 56 | Clinica Alemana de Santiago | Sola Jose | CHILE | CL-RM | Santiago |
| 57 | Clinica Alemana de Santiago | Salas Claudio | CHILE | CL-RM | Santiago |
| 58 | Fundacion Arturo Lopez Perez | Barajas Olga | CHILE | NA | Santiago |
| 59 | CLINICA UNIVERSIDAD CATOLICA DEL MAULE | Araya Hernan | CHILE | CL-ML | Talca |
| 60 | CLINICA UNIVERSIDAD CATOLICA DEL MAULE | Araya Hernan | CHILE | CL-ML | Talca |
| 61 | ICEGCLINIC | Garcia Eva | CHILE | CL-RM | Santaigo |
| 62 | National Taiwan University Hospital | Lu Yen-Shen | 中国台湾 | NA | Taipei |
| 63 | National Cheng Kung University Hospital | Chung Wei-Pang | 中国台湾 | NA | Tainan |
| 64 | Mackay Memorial Hospital | Chang Yuan-Ching | 中国台湾 | NA | Taipei |
| 65 | Chang Gung Memorial Hospital - Linkou | Chen Shih-Cheh | 中国台湾 | NA | Taoyuan |
| 66 | Taipei Veterans General Hospital | Tseng Ling-Ming | 中国台湾 | NA | Taipei |
| 67 | Changhua Christian Hospital | Chen Shou-Tung | 中国台湾 | NA | Changhua |
| 68 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Hou Ming-Feng | 中国台湾 | NA | Kaohsiung |
| 69 | Masarykuv Onkologicky Ustav | Petrakova Katarina | CZECH REPUBLIC | NA | Brno |
| 70 | Vseobecna Fakultni Nemocnice V Praze | Zimovjanova Martina | CZECH REPUBLIC | NA | Praha 2 |
| 71 | Onkologické centrum Multiscan | ODRAZKA Karel | CZECH REPUBLIC | NA | Pardubice |
| 72 | Rigshospitalet | KNOP Ann | DENMARK | NA | Kobenhavno |
| 73 | lborg Sygehus | Yammeni Sophie | DENMARK | NA | Alborg |
| 74 | Aarhus Universitetshospital Skejby | Jensen Anders | DENMARK | NA | Aarhus N |
| 75 | Sygehus Snderjylland Snderborg | Peric Jana | DENMARK | NA | Sonderborg |
| 76 | SA Phja-Eesti Regionaalhaigla | KüTNER Riina | ESTONIA | NA | Tallinn |
| 77 | SA Tartu ülikooli Kliinikum | Kallak Kersti | ESTONIA | NA | Tartu |
| 78 | HUS Sypkeskus | Karihtala Peeter | FINLAND | NA | Helsinki |
| 79 | Pirkanmaan sairaanhoitopiiri / Tays | Tanner Minna | FINLAND | NA | Tampere |
| 80 | Turun Yliopistollinen keskussairaala | Huovinen Riikka | FINLAND | NA | Turku |
| 81 | Vaasan keskussairaala | Jekunen Antti | FINLAND | NA | Vaasa |
| 82 | #Institut Curie - Site de Paris | Bidard Francois-Clement | FRANCE | NA | PARIS |
| 83 | #Hopital Saint Louis | TEIXEIRA Luis | FRANCE | NA | PARIS |
| 84 | #Gustave Roussy | Pistilli Barbara | FRANCE | NA | VILLEJUIF |
| 85 | Institut Claudius Regaud - IUCT-O | Dalenc Florence | FRANCE | NA | TOULOUSE Cedex 9 |
| 86 | #CHU Poitiers - Hopital La Miletrie | Isambert Nicolas | FRANCE | NA | Poitiers |
| 87 | #CHU Poitiers - Hopital La Miletrie | ISAMBERT Nicolas | FRANCE | NA | Poitiers |
| 88 | #Institut Curie - Site St-Cloud | Bidard Francois-Clement | FRANCE | NA | SAINT CLOUD |
| 89 | #Centre Leon Berard | Bachelot Thomas | FRANCE | NA | Lyon |
| 90 | #Centre Antoine Lacassagne | FERRERO Jean Marc | FRANCE | NA | Nice |
| 91 | ICANS | PETIT Thierry | FRANCE | NA | STRASBOURG |
| 92 | Acad Fridon Todua Medical Center LTD -Research Institute of Clinical Medicine LTD | Melkadze Tamar | GEORGIA | NA | Tbilisi |
| 93 | Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC | Gogishvili Miranda | GEORGIA | NA | Tbilisi |
| 94 | LTD Multiprofile Clinic Consilium Medula | Sanikidze Spiridon | GEORGIA | NA | Tbilisi |
| 95 | LTD Tbilisi Oncology Dispensary | Sikharulidze Irakli | GEORGIA | NA | Tbilisi |
| 96 | LTD High Technology Hospital Medcentre | Smionova Nino | GEORGIA | NA | Batumi |
| 97 | JSC Evex Clinics | Qitiashvili Tariel | GEORGIA | NA | Kutaisi |
| 98 | LTD Institute of Clinical Oncology | Nemsadze Diana | GEORGIA | NA | Tbilisi |
| 99 | Universit？tsklinikum Ulm | Ernst Kristina | GERMANY | NA | Ulm |
| 100 | Mammazentrum Hamburg | Schem Christian | GERMANY | NA | Hamburg |
| 101 | Universit？tsklinikum Münster | Tio Joke | GERMANY | NA | Münster |
| 102 | Klinikum Oberberg GmbH | Weishap Anja | GERMANY | NA | Gummersbach |
| 103 | Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház | Erfán József | HUNGARY | NA | Nyíregyháza |
| 104 | Debreceni Egyetem Klinikai K？zpont | árkosy Péter | HUNGARY | NA | Debrecen |
| 105 | Somogy Megyei Kaposi Mór Oktató Kórház | Bálint András | HUNGARY | NA | Kaposvár |
| 106 | Szent Margit Kórház | Boer Katalin | HUNGARY | NA | Budapest |
| 107 | Petz Aladár Megyei Oktató Kórház | Sip？cz István | HUNGARY | NA | Gyr |
| 108 | Szent Imre Egyetemi Oktatókórház | Nagy Zsuzsanna | HUNGARY | NA | Budapest |
| 109 | Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem általános Orvostudományi Kar Oktató Kórháza, Rendel？intézet | Horváth Zsolt | HUNGARY | NA | Kecskemét |
| 110 | Azienda Ospedaliera San Martino | Del Mastro Lucia | ITALY | IT-GE | Genova |
| 111 | Istituto Europeo di Oncologia | Colleoni Marco | ITALY | IT-MI | Milano |
| 112 | Istituto Clinico Humanitas | Torrisi Rosalba | ITALY | IT-MI | Rozzano |
| 113 | IRCCS Ospedale San Raffaele | Bianchini Giampaolo | ITALY | IT-MI | Milano |
| 114 | Nuovo Ospedale Santo Stefano | Biganzoli Laura | ITALY | IT-PO | Prato |
| 115 | Istituto Nazionale Tumori | De Laurentiis Michelino | ITALY | IT-NA | Napoli |
| 116 | Azienda Ospedaliera San Gerardo | CAZZANIGA MARINA | ITALY | IT-MB | Monza |
| 117 | Ist. Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | De Giorgi Ugo | ITALY | NA | Meldola (FC) |
| 118 | Ist. Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | De Giorgi Ugo | ITALY | NA | Meldola (FC) |
| 119 | National Hospital Organization Hokkaido Cancer Center | Takahashi Masato | JAPAN | NA | Sapporo-shi |
| 120 | National Cancer Center Hospital East | Mukohara Toru | JAPAN | NA | Kashiwa-shi |
| 121 | The Cancer Institute Hospital of JFCR | Kobayashi Takayuki | JAPAN | NA | Koto-ku |
| 122 | Showa University Hospital | Nakamura Seigo | JAPAN | NA | Shinagawa-ku |
| 123 | Kanagawa Cancer Center | Yamashita Toshinari | JAPAN | NA | Yokohama-shi |
| 124 | Aichi Cancer Center Hospital | IWATA Hisashi | JAPAN | PL-MZ | Nagoya-shi |
| 125 | National Hospital Organization Osaka National Hospital | Masuda Norikazu | JAPAN | PL-LD | Osaka-shi |
| 126 | Shikoku Cancer Center | Ohsumi Shozo | JAPAN | PL-WP | Matsuyama-shi |
| 127 | Hiroshima City Hiroshima Citizens Hospital | Itoh Mitsuya | JAPAN | PL-PM | Hiroshima-shi |
| 128 | Sagara Hospital | Taira Tetsuhiko | JAPAN | PL-ZP | Kagoshima-shi |
| 129 | Saitama Medical University International Medical Center | Osaki Akihiko | JAPAN | NA | Hidaka-shi |
| 130 | Yokohama Rosai Hospital | Chishima Takashi | JAPAN | NA | Yokohama-shi |
| 131 | Asan Medical Center | Jung KyungHae | KOREA, REPUBLIC OF | NA | Seoul |
| 132 | Samsung Medical Center | Park Yeonhee | KOREA, REPUBLIC OF | NA | Seoul |
| 133 | Seoul National University Hospital | Im Seock Ah | KOREA, REPUBLIC OF | NA | Seoul |
| 134 | Yonsei University Health System, Severance Hospital | Sohn JooHyuk | KOREA, REPUBLIC OF | NA | Seoul |
| 135 | Seoul National University Bundang Hospital | Jee Hyun Kim | KOREA, REPUBLIC OF | NA | Seongnam |
| 136 | National Cancer Center | LEE Keun Seok | KOREA, REPUBLIC OF | NA | Goyang-si |
| 137 | Korea University Anam Hospital | PARK Kyong Hwa | KOREA, REPUBLIC OF | NA | Krasnogorskiy district |
| 138 | CHA Bundang Medical Center, CHA University | Moon Yong Wha | KOREA, REPUBLIC OF | NA | Seongnam-si, Gyeonggi-do |
| 139 | The Catholic University of Korea, Seoul St. Mary's Hospital | Lee Jieun | KOREA, REPUBLIC OF | NA | Seochogu |
| 140 | “Hospital Universitario “Dr. José Eleuterio González” | Zayas-Villanueva Omar | MEXICO | MX-NLE | Monterrey |
| 141 | Arke SMO, S.A. de C.V | Navarrete-Aleman Jaime | MEXICO | MX-VER | Veracruz |
| 142 | Health Pharma Professional Research S.A. De C.V | Perez Perez Perla | MEXICO | MX-MEX | Benito Juarez |
| 143 | Unidad de Investigación Cima, S.C. | Aguayo Yong Rocio | MEXICO | MX-CHH | Chihuahua |
| 144 | Maastricht UMC+ | Tjan-Heijnen Vivianne | NETHERLANDS | NA | Maastricht |
| 145 | Spaarne Ziekenhuis | Kuijer Philomeen | NETHERLANDS | NA | Hoofddorp |
| 146 | Reinier De Graaf Gasthuis | Mammatas Lemonitsa | NETHERLANDS | NA | Delft |
| 147 | Ziekenhuis Rijnstate | Beelen Karin | NETHERLANDS | NA | Arnhem |
| 148 | Amphia Ziekenhuis Molengracht | HEIJNS Joan | NETHERLANDS | NA | Breda |
| 149 | Narodowy Instytut Onkologii | Nowecki Zbigniew | POLAND | PL-MZ | Warszawa |
| 150 | Specjalistyczny Szpital Onkologiczny NU-MED | CHMIELOWSKA Ewa | POLAND | PL-LD | Tomaszow Mazowiecki |
| 151 | Centrum Medyczne HCP | Kobylarek Robert | POLAND | PL-WP | Poznan |
| 152 | Szpitale Pomorskie Sp. z o.o. | Danielewicz Iwona | POLAND | PL-PM | Gdynia |
| 153 | Zachodniopomorskie Centrum Onkologii | TALERCZYK Malgorzata | POLAND | PL-ZP | Szczecin |
| 154 | Centro Hospitalar Lisboa Norte, E.P.E. – Hospital de Santa Maria | Costa Luis | PORTUGAL | NA | Lisboa |
| 155 | Centro Hospitalar Lisboa Norte, E.P.E. – Hospital de Santa Maria | Abreu Catarina | PORTUGAL | NA | Lisboa |
| 156 | Centro Hospitalar Lisboa Norte, E.P.E. – Hospital de Santa Maria | COSTA Lígia | PORTUGAL | NA | Lisboa |
| 157 | HOSPITAL DE SAO JOAO | Augusto Isabel | PORTUGAL | NA | PORTO |
| 158 | Centro Hospitalar do Porto - Hospital de Santo António | AFONSO Noémia | PORTUGAL | NA | PORTO |
| 159 | Hospital Garcia de Orta, EPE | Dias ？ngela | PORTUGAL | NA | Almada |
| 160 | Clinical Scientific and practical center for special types of medical care (oncology-oriented) | Chubenko Vyacheslav | RUSSIAN FEDERATION | NA | Saint -Petersburg |
| 161 | LLC | Moisseev Alexey | RUSSIAN FEDERATION | NA | Moscow |
| 162 | State Health Care Institution | Stroyakovskiy Daniil | RUSSIAN FEDERATION | NA | Krasnogorskiy district |
| 163 | FSBI National medical research center for obstetrics, gynecology and perinatalogy n.a. Kulakov MoH of Russian Federation | Khokhlova Svetlana | RUSSIAN FEDERATION | NA | Moscow |
| 164 | City clinical oncology hospital #1 | Pokataev Ilya | RUSSIAN FEDERATION | NA | Moscow |
| 165 | Arkhangelsk Clinical oncological dispensary | Nechaeva Marina | RUSSIAN FEDERATION | NA | Arkhangelsk |
| 166 | N.N. Blokhin National Medical Research Center of Oncology？ оf the Ministry of Health of the Russian Federation | Artamonova Elena | RUSSIAN FEDERATION | NA | Moscow |
| 167 | Join Stock Company “MEDSI group”,Clinical Hospital #1 | Mochalova Anastasia | RUSSIAN FEDERATION | NA | Moscow Region |
| 168 | AV Medical group | Shemerovskiy Alexander | RUSSIAN FEDERATION | NA | Saint Petersburg |
| 169 | Curie Oncology | Ngo Lynette | SINGAPORE | NA | Singapore |
| 170 | National University Hospital | Lee Soo Chin | SINGAPORE | NA | Singapore |
| 171 | Tan Tock Seng hospital | Heong Valerie | SINGAPORE | NA | Singapore |
| 172 | National Cancer Centre | Yap Yoon Sim | SINGAPORE | NA | Singapore |
| 173 | Hospital Universitario 12 de Octubre. | Ciruelos Gil Eva | SPAIN | NA | Madrid Madrid |
| 174 | Hospital Universitario HM Sanchinarro | Vega Alonso Estela | SPAIN | ES-MD | Madrid / Madrid |
| 175 | Hospital Clínico Universitario de Santiago-CHUS. | Lopez Rafael | SPAIN | ES-GA | Santiago de Compostela |
| 176 | Hospital Universitario La Paz. | ZAMORA Pilar | SPAIN | ES-M | Madrid |
| 177 | Hospital Clinico Universitario de Valencia | Bermejo Begoa | SPAIN | ES-VC | Valencia / Valencia |
| 178 | Hospital General Universitario Gregorio Mara？ón. | JEREZ GILARRANZ YOLANDA | SPAIN | ES-MD | Madrid / Madrid |
| 179 | Hospital Virgen de la Victoria | RIBELLES Nuria | SPAIN | ES-MA | Málaga |
| 180 | Consorci Corporació Sanitària Parc Taulí de Sabadell. | FERNANDEZ-MORALES LUIS | SPAIN | ES-CL | Barcelona / Sabadell |
| 181 | Hospital Universitari Arnau de Vilanova. | Llombart Cussac Antonio | SPAIN | ES-CL | Lleida / Lleida |
| 182 | Institut Dexeus | Pérez García Jose Manuel | SPAIN | ES-B | Barcelona |
| 183 | Medipol Mega üniversite Hastanesi | Bilici Ahmet | TURKEY | NA | Istanbul |
| 184 | NNü üNVERSTES TURGUT ZAL TIP MERKE | Harputluoglu Hakan | TURKEY | NA | Malatya |
| 185 | Trakya University Medicine Faculty | CICIN IRFAN | TURKEY | NA | Edirne |
| 186 | Istanbul Medeniyet Universitesi Goztepe EAH | Gumus Mahmut | TURKEY | NA | Istanbul |
| 187 | Ege Universitesi Tip Fakultesi | Gokmen Erhan | TURKEY | NA | Bornova |
| 188 | Baskent Universitesi Adana Uygulama Ve Arastirma Hastanesi | ozyilkan ozgur | TURKEY | NA | Adana |
| 189 | Akdeniz üniversitesi Hastanesi | Goksu Sema | TURKEY | NA | Antalya |
| 190 | Hacettepe Universitesi Onkoloji Enstitusu | aksoy sercan | TURKEY | NA | Ankara |
| 191 | Dr. Abdurrahman Yurtaslan Ankara Onkoloji E？itim ve Ara？t？rma Hastanesi | Oksuzoglu Berna | TURKEY | NA | Ankara |
| 192 | Kocaeli üniversitesi Aratrma ve Uygulama Hastanesi | Cabuk Devrim | TURKEY | NA | Kocaeli |
| 193 | Acbadem Maslak Hastanesi | ERALP Yesim | TURKEY | NA | Istanbul |
| 194 | zmir Ekonomi üniversitesi Medcal Park Hastanesi | Arslan Cagatay | TURKEY | NA | zmir |
| 195 | Dicle üniversitesi Tp Fakültesi Tbbi Onkoloji Anabilim Dal？ | Kaplan Muhammet Ali | TURKEY | NA | Diyarbakr |
| 196 | Communal enterprise | Adamchuk Hryhoriy | UKRAINE | NA | Kryvyi Rih |
| 197 | Odesa Regional Clinical Hospital | Berzoy Oleksandr | UKRAINE | NA | Odesa |
| 198 | State institution V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine | Dudnichenko Oleksandr | UKRAINE | NA | Kharkiv |
| 199 | Podillia Regional Oncology Center of Vinnytsia Regional Council | Shevnia Serhii | UKRAINE | NA | Vinnytsia |
| 200 | Regional Clinical SpecializedDispensary for Radiation Protection of Citizenry | Neffa Maryna | UKRAINE | NA | Kharkiv |
| 201 | Regional Clinical SpecializedDispensary for Radiation Protection of Citizenry | Neffa Maryna | UKRAINE | NA | Kharkiv |
| 202 | Beatson West Of Scotland Cancer Centre | MacPherson Iain | UNITED KINGDOM | GB-CBF | Glasgow |
| 203 | Western General Hospital | Oikonomidou Olga | UNITED KINGDOM | GB-EDH | Edinburgh |
| 204 | Churchill Hospital | Lord Simon | UNITED KINGDOM | GB-OXF | Torrance |
| 205 | University of Pittsburgh Medical Center - Hillman Cancer Ctr | Brufsky Adam | UNITED STATES | US-PA | PITTSBURGH |
| 206 | Michigan Medicine (University of Michigan) | Smerage Jeffrey | UNITED STATES | US-MI | Ann Arbor |
| 207 | Oncology Health Group | Betancourt Rafael | UNITED STATES | US-PR | Hato Rey |
| 208 | Siteman Cancer Center | MA Cynthia | UNITED STATES | US-MO | St Louise |
| 209 | Saint Luke's Hospital Of Kansas City | Pluard Timothy | UNITED STATES | US-MO | Kansas City |
| 210 | University of Iowa Hospitals and Clinics | VIKAS PRAVEEN | UNITED STATES | US-IA | Iowa City |
| 211 | Fort Wayne Medical Oncology and Hematology | Babu Sunil | UNITED STATES | US-IN | Fort Wayne |
| 212 | Wake Forest University Health Sciences | Thomas Alexandra | UNITED STATES | US-NC | Winston-Salem |
| 213 | NYU Langone Medical Center | NOVIK Yelena | UNITED STATES | US-NY | New York |
| 214 | University of Kansas Medical Center (KUMC) | Sharma Priyanka | UNITED STATES | US-KS | Westwood |
| 215 | Rutgers Cancer Institute | Omene Coral | UNITED STATES | US-NJ | New Brunswick |
| 216 | Northside Hospital Cancer Institute | Volas-Redd Gena | UNITED STATES | US-GA | Atlanta |
| 217 | Massachusetts General Hospital | Bardia Aditya | UNITED STATES | US-MA | Boston |
| 218 | Cleveland Clinic Florida | Samuel Thomas | UNITED STATES | US-FL | Fort Lauderdale |
| 219 | Cleveland Clinic Florida | Nahleh Zeina | UNITED STATES | US-FL | Fort Lauderdale |
| 220 | Stony Brook Hospital and Medical Center | Baer Lea | UNITED STATES | US-NY | Stony Brook |
| 221 | Stony Brook Hospital and Medical Center | Stopeck Alison | UNITED STATES | US-NY | Stony Brook |
| 222 | Valley Hospital | Teplinsky Eleonora | UNITED STATES | US-NJ | Paramus |
| 223 | University of Colorado | Kabos Peter | UNITED STATES | US-CO | Denver |
| 224 | University of Massachusetts | Toke Madhavi | UNITED STATES | US-MA | Worcester |
| 225 | Penn State Milton S. Hershey Medical Center | Truica Cristina | UNITED STATES | US-PA | HERSHEY |
| 226 | Maine Center for Cancer Medicine | Battelli Chiara | UNITED STATES | US-ME | Scarborough |
| 227 | UCLA Hematology Oncology Parkside | HURVITZ Sara | UNITED STATES | US-CA | Santa Monica |
| 228 | Regional Cancer Care Associates, LLC | Fang Bruno | UNITED STATES | US-NJ | East Brunswick |
| 229 | Lundquist Institute for Biomedical Innovation | Onyshchenko Mykola | UNITED STATES | US-CA | Torrance |
| 230 | Summit Cancer Care | Taylor Mark | UNITED STATES | US-GA | Savannah |
| 231 | Lewis Hall Singletary Oncology Center | Simmons Josh | UNITED STATES | US-GA | Thomasville |
| 232 | Olive View UCLA Medical Center | Chiu Victor | UNITED STATES | US-CA | Sylmar |
| 233 | Comprehensive Cancer Centers of Nevada | Christensen Stephani | UNITED STATES | US-NV | Henderson |
| 234 | St. Joseph Heritage Healthcare | LAWLER William | UNITED STATES | US-CA | Fullerton |
| 235 | University of Illinois at Chicago | Danciu Oana | UNITED STATES | US-IL | Chicago |
| 236 | Ucsf Comprehensive Ca Center | Rugo Hope | UNITED STATES | US-CA | San Francisco |
| 237 | Memorial Healthcare System | Milillo Naraine Adriana | UNITED STATES | US-FL | Hollywood |
| 238 | Bon Secours St. Francis Medical Center | Irvin William | UNITED STATES | US-VA | Midlothian |
| 239 | Virginia Commonwealth University | Ross Masey | UNITED STATES | US-VA | Richmond |
| 240 | Orlando Health, UF Health Cancer Center | Cuesta Fernandez Ana | UNITED STATES | US-FL | Orlando |
| 241 | West Virginia University | Salkeni Mohamad | UNITED STATES | US-WV | Morgantown |
| 242 | UCHealth Cancer Care and Hematology | SCHUSTER Steven | UNITED STATES | US-CO | Fort Collins |
| 243 | UCHealth Cancer Care and Hematology | Medgyesy Diana | UNITED STATES | US-CO | Fort Collins |
| 244 | UCHealth Medical Group Hematology/Oncology | Hoyer Robert | UNITED STATES | US-CO | Colorado Springs |
| 245 | PIH Health | Wang Lisa Shing-E Lu | UNITED STATES | US-CA | Whittier |
| 246 | AdventHealth Orlando | ALEMANY Carlos | UNITED STATES | US-FL | Orlando |
| 247 | New Jersey Cancer Care and Blood Disorders | ORSINI James | UNITED STATES | US-NJ | Belleville |
| 248 | University Cancer and Blood Center | SHEPHERD Cynthia | UNITED STATES | US-GA | Athens |
| 249 | Cancer and Blood Specialty Clinic | Abdulla Nihal | UNITED STATES | US-CA | Los Alamitos |
| 250 | NYU Langone- Winthrop | NOVIK Yelena | UNITED STATES | US-NY | Mineola |
| 251 | OptumCare Cancer Center | Gollard Russell | UNITED STATES | US-NV | Las Vegas |
| 252 | OptumCare Cancer Center | Jahangir Khawaja Saad | UNITED STATES | US-NV | Las Vegas |
| 253 | Watson Clinic | Mulaparthi Shalini | UNITED STATES | US-FL | Lakeland |
| 254 | Oklahoma Cancer Specialists and Research Institute | Moussa Ali | UNITED STATES | US-OK | Tulsa |
| 255 | Oncology Consultants | Alvarez Ricardo | UNITED STATES | US-TX | Houston |
| 256 | Illinois Cancer Care | Rehman Nadia | UNITED STATES | US-IL | Peoria |
| 257 | Texas Oncology - San Antonio | Aponte Emmalind | UNITED STATES | US-TX | San Antonio |
| 258 | Arizona Oncology Associates | Ahmed Aisha | UNITED STATES | US-AZ | Tucson |
| 259 | Northwest Cancer Specialists, P.C. | Andersen Jay | UNITED STATES | US-OR | Tigard |
| 260 | Texas Oncology - Memorial City | Cairo Michelina | UNITED STATES | US-TX | Houston |
| 261 | Shenandoah Oncology, P.C. | Houck, III William | UNITED STATES | US-VA | Winchester |
| 262 | Texas Oncology, PA | BLUM Joanne | UNITED STATES | US-TX | Dallas |
| 263 | Texas Oncology Baylor Sammons | Manhas Atisha | UNITED STATES | US-TX | Dallas |
| 264 | Texas Oncology - Methodest Dallas Cancer Center | MCINTYRE Kristi | UNITED STATES | US-TX | Dallas |
| 265 | Texas Oncology, PA | Patt Debra | UNITED STATES | US-TX | Austin |
| 266 | Texas Oncology, PA | Sanchez-Rivera Ines | UNITED STATES | US-TX | El Paso |
| 267 | Southern Cancer Center, P.C | Meshad Michael | UNITED STATES | US-AL | Daphne |
| 268 | Texas Oncology, P.A. | ENCARNACION Carlos | UNITED STATES | US-TX | Waco |
| 269 | Cancer Care Centers of Brevard, Inc | Kancharla Venkat Pavan | UNITED STATES | US-FL | Palm Bay |
| 270 | Texas Oncology - Deke Slayton Cancer Center | Kodali Dhatri | UNITED STATES | US-TX | Webster |
| 271 | Texas Oncology - Plano West | Kovoor Philip | UNITED STATES | US-TX | Plano |
| 272 | Illinois Cancer Specialists | Sobol Urszula | UNITED STATES | US-IL | Arlington Heights |
| 273 | Borsod-Abaúj-Zemplén Megyei Kzponti Kórház és Egyetemi Oktatókórház | Revesz Janos | HUNGARY | NA | Miskolc |
| 274 | Wielkopolskie Centrum Onkologii Oddzia Chemioterapii z Izb Przyjec im. Marii Skodowskiej-Curie | Kufel-Grabowska Joanna | Poznan | NA | POLAND |
| 275 | Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital | DEMETRIOU Georgia | SOUTH AFRICA | NA | DEMETRIOU |
| 276 | The Medical Oncology Centre of Rosebank | Rapoport Bernardo | SOUTH AFRICA | NA | Rapoport |
| 277 | MERC SiReN | Yusuf MAYET | SOUTH AFRICA | NA | TAYOB (MAYET) |
| 278 | Cape Town Oncology Trials | JACOBS Conrad | SOUTH AFRICA | NA | JACOBS |
| 279 | Eastleigh Breast and Women's Health Centre | COCCIA-PORTUGAL Maria | SOUTH AFRICA | NA | COCCIA-PORTUGAL |
| 280 | Westrand Oncology Centre | GELDENHUYS D | SOUTH AFRICA | NA | GELDENHUYS |
| 281 | 大连医科大学附属第一医院 | 高亚杰 | 中国 | 辽宁省 | 大连市 |
| 282 | 华中科技大学同济医学院附属协和医院 | 程晶 | 中国 | 湖北省 | 武汉市 |
| 283 | 北京医院 | 张永强 | 中国 | 北京市 | 北京市 |
| 284 | 吉林大学第二医院 | 徐景伟 | 中国 | 吉林省 | 长春市 |
| 285 | 粤北人民医院 | 雷睿文 | 中国 | 广东省 | 韶关市 |
| 286 | 河北大学附属医院 | 臧爱民 | 中国 | 河北省 | 保定市 |
| 287 | 安徽省肿瘤医院 | 胡长路 | 中国 | 安徽省 | 合肥市 |
| 288 | 中国人民解放军联勤保障部队第九〇〇医院 | 陈曦 | 中国 | 福建省 | 福州市 |
| 289 | 西安交通大学第二附属医院 | 张淑群 | 中国 | 陕西省 | 西安市 |
| 290 | 西安交通大学第一附属医院 | 杨谨 | 中国 | 陕西省 | 西安市 |
| 291 | 山东省肿瘤医院 | 王永胜 | 中国 | 山东省 | 济南市 |
| 292 | 内江市第二人民医院 | 王绪娟 | 中国 | 四川省 | 内江市 |
| 293 | 烟台毓璜顶医院 | 乔广东 | 中国 | 山东省 | 烟台市 |
| 294 | 遂宁市中心医院 | 杨宏伟 | 中国 | 四川省 | 遂宁市 |
| 295 | 济宁医学院附属医院 | 山长平 | 中国 | 山东省 | 济宁市 |
| 296 | 新疆医科大学附属肿瘤医院 | 孙刚 | 中国 | 新疆维吾尔自治区 | 乌鲁木齐市 |
| 297 | 四川省肿瘤医院 | 李卉 | 中国 | 四川省 | 成都市 |
| 298 | 德阳市人民医院 | 贾新建 | 中国 | 四川省 | 德阳市 |
| 299 | 河南科技大学第一附属医院 | 王新帅 | 中国 | 河南省 | 洛阳市 |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | 复旦大学附属肿瘤医院医学伦理委员会 | 同意 | 2020-12-14 |
| 2 | 复旦大学附属肿瘤医院医学伦理委员会 | 同意 | 2021-08-10 |
六、试验状态信息
1、试验状态
进行中（招募完成）
2、试验人数
| 目标入组人数 | 国内: 160 ； 国际: 708 ； |
|---|---|
| 已入组人数 | 国内: 169 ； 国际: 1068 ； |
| 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； |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 | 国内：2021-03-31； 国际：2020-10-14； |
|---|---|
| 第一例受试者入组日期 | 国内：2021-04-13； 国际：2020-11-19； |
| 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； |
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