上海帕妥珠单抗注射液其他临床试验-帕妥珠单抗HER2阳性晚期乳腺癌安全性研究
上海复旦大学附属肿瘤医院开展的帕妥珠单抗注射液其他临床试验信息，需要患者受试者,主要适应症为HER2阳性晚期乳腺癌
| 登记号 | CTR20130952 | 试验状态 | 已完成 |
|---|---|---|---|
| 申请人联系人 | 徐艳 | 首次公示信息日期 | 2014-11-26 |
| 申请人名称 | F.Hoffmann-La Roche Ltd./ Roche Diagnostics GmbH/ 上海罗氏制药有限公司 | ||
一、题目和背景信息
| 登记号 | CTR20130952 | ||
|---|---|---|---|
| 相关登记号 | 暂无 | ||
| 药物名称 | 帕妥珠单抗注射液 | ||
| 药物类型 | 生物制品 | ||
| 临床申请受理号 | JXSL1200006 | ||
| 适应症 | HER2阳性晚期乳腺癌 | ||
| 试验专业题目 | 帕妥珠单抗联合曲妥珠单抗和紫杉烷类作为HER2阳性的晚期（乳腺癌患者的一线治疗多中心开放单组研究 | ||
| 试验通俗题目 | 帕妥珠单抗HER2阳性晚期乳腺癌安全性研究 | ||
| 试验方案编号 | MO28047 （5.0版） | 方案最新版本号 | V6.0 |
| 版本日期: | 2018-11-21 | 方案是否为联合用药 | 企业选择不公示 |
二、申请人信息
| 申请人名称 |
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| 联系人姓名 | 徐艳 | 联系人座机 | 021-28946023 | 联系人手机号 | |
| 联系人Email | audrey.xu@roche.com | 联系人邮政地址 | 上海市-上海市-上海市浦东新区龙东大道1100号 上海罗氏制药有限公司 | 联系人邮编 | 201203 |
三、临床试验信息
1、试验目的
评价帕妥珠单抗联合曲妥珠单抗和一种紫杉烷类的安全性和耐受性 2、试验设计
| 试验分类 | 安全性 | 试验分期 | 其他 | 设计类型 | 单臂试验 |
|---|---|---|---|---|---|
| 随机化 | 非随机化 | 盲法 | 开放 | 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 N/A岁(最大年龄) | ||||||||||||||||||||||||||||||||||||||||
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| 性别 | 男+女 | ||||||||||||||||||||||||||||||||||||||||
| 健康受试者 | 无 | ||||||||||||||||||||||||||||||||||||||||
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| 排除标准 |
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4、试验分组
| 试验药 |
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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 | 胡夕春 | 学位 | 医学博士 | 职称 | 主任医师 |
|---|---|---|---|---|---|---|
| 电话 | 13816110335 | xchu2009@hotmail.com | 邮政地址 | 上海市-上海市-上海市徐汇区东安路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 | 胡夕春 | 中国 | 上海市 | 上海市 |
| 2 | 北京肿瘤医院 | 李惠萍 | 中国 | 北京市 | 北京市 |
| 3 | 江苏省肿瘤医院 | 冯继锋 | 中国 | 江苏省 | 南京市 |
| 4 | 中山大学附属肿瘤医院 | 王树森 | 中国 | 广东省 | 广州市 |
| 5 | 西安交通大学医学院第一附属医院 | 李恩孝 | 中国 | 陕西省 | 西安市 |
| 6 | 天津市肿瘤医院 | 佟仲生 | 中国 | 天津市 | 天津市 |
| 7 | 第三军医大学附属西南医院 | 姜军 | 中国 | 重庆市 | 重庆市 |
| 8 | 第四军医大学西京医院 | 李南林 | 中国 | 陕西省 | 西安市 |
| 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 | CPMC; Service d'Oncologie Médicale | KAMEL BOUZID | ALGERIA | ALGIERS | Algiers |
| 11 | Centro Oncologico Riojano Integral (CORI) | Luis Kaen | ARGENTINA | LA RIOJA | La Rioja |
| 12 | Instituto de Oncología de Rosario | Luis Fein | ARGENTINA | ROSARIO | Rosario |
| 13 | AUSTIN AND REPATRIATION MEDICAL CENTRE; CANCER SERVICES | Jacqui Thomson | AUSTRALIA | Victoria | MELBOURNE |
| 14 | CANBERRA HOSPITAL; MEDICAL ONCOLOGY | ROBIN STUART-HARRIS | AUSTRALIA | Australian Capital Territory | CANBERRA |
| 15 | HOCA Chermside | Nicole McCarthy | AUSTRALIA | Queensland | Chermside |
| 16 | ROYAL MELBOURNE HOSPITAL; HEMATOLOGY AND MEDICAL ONCOLOGY | RICHARD DE BOER | AUSTRALIA | Victoria | PARKVILLE |
| 17 | Royal Prince Alfred Hospital; Medical Oncology | JANE BEITH | AUSTRALIA | New South Wales | Camperdown |
| 18 | LKH SALZBURG - UNIV. KLINIKUM SALZBURG; III. MEDIZINISCHE ABT. | RICHARD GREIL | AUSTRIA | Salzburg | Salzburg |
| 19 | LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | HELLMUT SAMONIGG | AUSTRIA | Steiermark | GRAZ |
| 20 | UNIVERSIT？TSKLINIK FüR FRAUENHEILKUNDE; KLINIK FüR GYN？KOLOGIE IV | CHRISTIAN SINGER | AUSTRIA | WIEN | WIEN |
| 21 | KH Der Barmherzigen Schwestern; Abteilung für Innere Medizin 1 | ANDREAS PETZER | AUSTRIA | Upper Austria | LINZ |
| 22 | UNIVERSITAIR ZIEKENHUIS BRUSSEL; ONCOLOGY | JACQUES DE GREVE | BELGIUM | BRUXELLES | BRUXELLES |
| 23 | UNIVERSITAIR ZIEKENHUIS; ONCOLOGIE - CANCEROLOGIE | Veronique Cocquyt | BELGIUM | GENT | GENT |
| 24 | U.Z. GASTHUISBERG; ONCOLOGY | Hans Wildiers | BELGIUM | LEUVEN | LEUVEN |
| 25 | CHU Sart Tilman | GUY JERUSALEM | BELGIUM | LIEGE | Liège |
| 26 | Hospital Amaral Carvalho | Augusto BeatoCarlos | BRAZIL | SP | Jau |
| 27 | Hospital das Clinicas - FMUSP Ribeirao Preto | Jurandyr Moreira de Andrade | BRAZIL | SP | Ribeirao Preto |
| 28 | Hospital Perola Byington | Roberto Hegg | BRAZIL | SP | Sao Paulo |
| 29 | Hospital Sao Jose | Marceio Curz | BRAZIL | SP | Sao Paulo |
| 30 | Hospital Sao Lucas - PUCRS | Carlos Henrique Barrios | BRAZIL | RS | Porto Alegre |
| 31 | HOSPITAL SIRIO LIBANES; CENTRO DE ONCOLOGIA | Max Mano | BRAZIL | SP | Sao Paulo |
| 32 | ONCOLOGISTAS ASSOCIADOS | Gilberto Luiz Amorim | BRAZIL | RJ | Rio de Janeiro |
| 33 | BCCA - VANCOUVER ISLAND CANCER CENTRE; ONCOLOGY | Nicole Macpherson | CANADA | British Columbia | VICTORIA |
| 34 | Capital Health; QEII HSC; Oncology | DANIEL RAYSON | CANADA | Nova Scotia | Halifax |
| 35 | CHUM - HOTEL DIEU DE MONTREAL | Andre Robidoux | CANADA | Quebec | MONTREAL |
| 36 | CROSS CANCER INSTITUTE ; DEPT OF MEDICAL ONCOLOGY | ANIL ABRAHAM JOY | CANADA | Alberta | EDMONTON |
| 37 | CSSS champlain - Charles-Le Moyne | Susan Fox | CANADA | Quebec | Greenfield Park |
| 38 | GRAND RIVER REGIONAL CANCER CENTRE | Nadia Califaretti | CANADA | Ontario | Kitchener |
| 39 | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | LAWRENCE PANASCI | CANADA | Quebec | MONTREAL |
| 40 | SUNNYBROOK ODETTE CANCER CENTRE | SUNIL VERMA | CANADA | Ontario | Toronto |
| 41 | William Osler Health System Brampton Civic Hospital | SANDEEP SEHDEV | CANADA | Ontario | Brampton |
| 42 | HOSPITAL SOLCA PORTOVIEJO; ONCOLOGIA | Miguel Cedeao | ECUADOR | QUITO | PORTOVIEJO |
| 43 | HOSPITAL SOLCA QUITO; ONCOLOGIA | Tannia Soria | ECUADOR | QUITO | QUITO |
| 44 | Manial Specialized Hospital; Oncology | AZEEM HAMDY ABDEL | EGYPT | CAIRO | Cairo |
| 45 | NCI; ONCOLOGY DEPT | Rabab Gaafar | EGYPT | CAIRO | Cairo |
| 46 | North Estonia Medical Centre Foundation; Oncology Center | Riina Kutner | ESTONIA | TALINN | Tallinn |
| 47 | Tartu University Hospital; Clinic of Hematology and Oncology | PEETER PADRIK | ESTONIA | TARTU | Tartu |
| 48 | HELSINKI UNIVERSITY CENTRAL HOSPITAL; ONCOLOGY CLINICS | Johanna Mattson | FINLAND | HELSINKI | HELSINKI |
| 49 | SATAKUNTA CENTRAL HOSPITAL; ONCOLOGY | OUTI SAARNI | FINLAND | PORI | PORI |
| 50 | TAMPERE UNIVERSITY HOSPITAL; DEPT OF ONCOLOGY | MINNA TANNER | FINLAND | TAMPERE | Tampere |
| 51 | TURKU UNI CENTRAL HOSPITAL; ONCOLOGY CLINICS | Johanna Ruohola | FINLAND | TURKU | Turku |
| 52 | Centre Azureen De Cancerologie; Cons externes | REMY LARGILLIER | FRANCE | MOUGINS | MOUGINS |
| 53 | CENTRE CATALAN D' ONCOLOGIE | Stephanie Catala | FRANCE | PERPIGNAN | PERPIGNAN |
| 54 | CENTRE EUGENE MARQUIS; UNITE HUGUENIN | Christophe Perrin | FRANCE | RENNES | Rennes |
| 55 | Centre Georges Francois Leclerc; Oncologie 3 | Bruno Coudert | FRANCE | DIJON | Dijon |
| 56 | CENTRE HOSPITALIER FLEYRIAT; ONCOLOGIE/HEMATOLOGIE | HUBERT ORFEUVRE | FRANCE | BOURG EN BRESSE | BOURG EN BRESSE |
| 57 | Centre Leonard De Vinci;Chimiotherapie | Virginie Pottier | FRANCE | DECHY | Dechy |
| 58 | Centre Leon Berard; Departement Oncologie Medicale | THOMAS BACHELOT | FRANCE | LYON | Lyon |
| 59 | Centre Rene Huguenin; ONCOLOGIE GENETIQUE | ETIENNE BRAIN | FRANCE | SAINT CLOUD | Saint Cloud |
| 60 | Chp Saint Gregoire; Cancerologie Radiotherapie | Xavier Artignan | FRANCE | SAINT GREGOIRE | SAINT GREGOIRE |
| 61 | CLINIQUE CHENIEUX; ONCOLOGY | Dominique Genet | FRANCE | LIMOGES | Limoges |
| 62 | Institut D Oncologie Medical | Mihaela Achille | FRANCE | STRASBOURG | STRASBOURG |
| 63 | Clinique De L Europe; Radiotherapie Chimiotherapie | MICHEL GOZY | FRANCE | AMIENS | Amiens |
| 64 | Clinique Du Docteur Calabet; Cromg | Olivier Bernard | FRANCE | AGEN | Agen |
| 65 | Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie | Jessica Grosjean | FRANCE | VALENCIENNES | Valenciennes |
| 66 | CLINIQUE SAINTE MARGUERITE; ONCOLOGIE MEDICALE | JEAN-FRANCOIS BERDAH | FRANCE | HYERES | HYERES |
| 67 | Clinique Victor Hugo | Hugues Bourgeois | FRANCE | LEMANS | LeMans |
| 68 | Crlcc Paul Papin; Oncologie Medicale | Paule Augereau | FRANCE | ANGERS | Angers |
| 69 | Hopital Cochin; Unite Fonctionnelle D Oncologie | JEROME ALEXANDRE | FRANCE | PARIS | Paris |
| 70 | Ico Rene Gauducheau; Oncologie | MARIO CAMPONE | FRANCE | SAINT HERBLAIN | Saint Herblain |
| 71 | Institut Claudius Regaud; Departement Oncologie Medicale | FLORENCE DALENC | FRANCE | TOULOUSE | Toulouse |
| 72 | Institut Curie; Oncologie Medicale | VERONIQUE DIERAS | FRANCE | PARIS | Paris |
| 73 | INSTITUT PAOLI CALMETTES; ONCOLOGIE MEDICALE | Anthony Goncalves | FRANCE | MARSEILLE | Marseille |
| 74 | POLYCLINIQUE BORDEAUX NORD AQUITAINE; CHIMIOTHERAPIE RADIOTHERAPIE | NADINE DOHOLLOU | FRANCE | BORDEAUX | BORDEAUX |
| 75 | POLYCLINIQUE DE BLOIS; CHIMIOTHERAPIE AMBULATOIRE | Philippe Laplaige | FRANCE | LA CHAUSSEE ST VICTOR | La Chaussee St Victor |
| 76 | Polyclinique De Courlancy; Centre Radiotherapie Oncologie | THOMAS FACCHINI | FRANCE | REIMS | REIMS |
| 77 | Polyclinique Du Languedoc; Chimiotherapie | Andre Mathieu | FRANCE | NARBONNE | Narbonne |
| 78 | Hopital Prive Drome Ardeche; Hopital De Jour | Hugues Barletta | FRANCE | GUIHERAND GRANGES | Guilherand Granges |
| 79 | HOPITAL SAINT LOUIS; SERVICE ONCO THORACIQUE | Luis Teixeira | FRANCE | PARIS | PARIS |
| 80 | Agaplesion Diakonieklinikum Rotenburg | Tobias Hesse | GERMANY | Hesse-Darmstadt | ROTENBURG-WUEMME |
| 81 | EV. KRANKENHAUS BETHESDA; M？NCHENGLADBACH GGMBH | Raquel von Schumann | GERMANY | Nordrhein-Westfalen | M？nchengladbach |
| 82 | Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding | Hans- Joachim Lueck | GERMANY | Saxony | Hannover |
| 83 | Gyn？kologicum Bremen Prof.Dr. Willibald Schr？der | Willibald Schrader | GERMANY | Transdisciplinary programs | Bremen |
| 84 | Klinikum am Bruderwald; Frauenklinik | Roland Repp | GERMANY | Freistaat Bayern | Bamberg |
| 85 | Klinikum Esslingen Klinik f. Frauenheilkunde und Geburtshilfe | Thorsten Kuehn | GERMANY | Baden-Württemberg | Esslingen |
| 86 | Klinikum rechts der Isar - Technische Uni München; Frauenklinik & Poliklinik | Johannes Ettl | GERMANY | Freistaat Bayern | München |
| 87 | Kreiskrankenhaus Torgau Abt.Gyn？kologie und Geburtshilfe | Eike Simon | GERMANY | Saxony | Torgau |
| 88 | Nationales Centrum für Tumorerkrankungen (NCT) | Andreas Schneeweiss | GERMANY | Baden-Württemberg | Heidelberg |
| 89 | Praxis Dr. Wagner | Steffen Wagner | GERMANY | saarland | Saarbruecken |
| 90 | Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe | Bernd Christensen | GERMANY | Brandenburg | Neuruppin |
| 91 | SRH Wald-Klinikum Gera Klinik f.Frauenheilkunde und Geburtshilfe | DIRK-MICHAEL ZAHM | GERMANY | Freistaat Thüringen | Gera |
| 92 | St.-Vincenz-Krankenhaus Frauenklinik | Angelika Ober | GERMANY | LIMBURG | Limburg |
| 93 | Uniklinik Tübingen; Frauenklinik | Eva-Maria Grischke | GERMANY | Baden-Württemberg | Tübingen |
| 94 | Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe | Ingolf Juhasz-Bass | GERMANY | Hesse-Darmstadt | Homburg/Saar |
| 95 | Universitatsklinikum Erlangen; Frauenklinik | Michael Lux | GERMANY | Freistaat Bayern | Erlangen |
| 96 | Universitatsklinikum Essen; Zentrum Für Frauenheilkunde | Bahriye Aktas | GERMANY | Nordrhein-Westfalen | Essen |
| 97 | Universitatsklinikum Hamburg-Eppendorf; Frauenklinik | Volkmarv Mueller | GERMANY | HAMBURG | Hamburg |
| 98 | Universitatsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Achim Rody | GERMANY | Holstein | Lübeck |
| 99 | AGAPLESION Markus-Krankenhaus) | Fariba Khandan | GERMANY | Hesse-Darmstadt | Frankfurt am Main |
| 100 | Papageorgiou General Hospital; Medical Oncology | GEORGE FOUNTZILAS | GREECE | THESSALONIKI | Thessaloniki |
| 101 | University General Hospital of Heraklion | Dimitris Mavroudis | GREECE | GRETE | Crete |
| 102 | UNIVERSITY HOSPITAL OF LARISSA; ONCOLOGY | CHRISTOS PAPANDREOU | GREECE | LARISSA | LARISSA |
| 103 | UNIVERSITY HOSPITAL OF PATRAS; MEDICAL ONCOLOGY | HARALABOS KALOFONOS | GREECE | PATRAS | PATRAS |
| 104 | QUEEN ELIZABETH HOSPITAL; CLINICAL ONCOLOGY | ROGER NGAN | HONG KONG | HONG KONG | HONG KONG |
| 105 | BORSOD-ABAUJ-ZEMPLEN MEGYEI KORHAZ ES EGYETEMI OKTATO KORHAZ; ONKOLOGIAI OSZTALY | Janos Revesz | HUNGARY | MISKOLC | Miskolc |
| 106 | DEBRECENI EGYETEM ORVOS ES EGESZSEGTUDOMANYI CENTRUM; ONKOLOGIAI TANSZEK | Zsolt Horvath | HUNGARY | DEBRECEN | DEBRECEN |
| 107 | FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET; ONKOLOGIAI OSZTALY | GYORGY BODOKY | HUNGARY | BUDAPEST | BUDAPEST |
| 108 | ORSZAGOS ONKOLOGIAL INTEZET; ONKOLOGIAI OSZTALY | ISTVAN LANG | HUNGARY | BUDAPEST | BUDAPEST |
| 109 | SZEGEDI TUDOMANYEGYETEM SZENT GYORGYI ALBERT ORVOS ES GYOGYSZERES; ONKOTERAPIAS KLINIKA | Zsuzsanna Kahan | HUNGARY | SZEGED | Szeged |
| 110 | Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai | KATALIN BOER | HUNGARY | BUDAPEST | BUDAPEST |
| 111 | Assuta Medical Centre; Oncology | Irina Jiveliouk | ISRAEL | TEL AVIV | Tel Aviv |
| 112 | CHAIM SHEBA MEDICAL CENTER; ONCOLOGY DEPT | Shani Paluch-Shimon | ISRAEL | RAMAT-GAN | Ramat-Gan |
| 113 | HADASSAH EIN KAREM HOSPITAL; ONCOLOGY DEPT | Tamar PERETZ | ISRAEL | JERUSALEM | JERUSALEM |
| 114 | KAPLAN MEDICAL CENTER; ONCOLOGY INST. | NOA BEN BARUCH | ISRAEL | REHOVOT | Rehovot |
| 115 | NAHARIYA HOSPITAL; ONCOLOGY | Hadassah Goldberg | ISRAEL | NAHARIYA | NAHARIYA |
| 116 | Rabin Medical Center; Oncology Dept | SALOMON STEMMER | ISRAEL | PETACH TIKVA | PETACH TIKVA |
| 117 | RAMBAM MEDICAL CENTER; ONCOLOGY | GEORGETA FRIED | ISRAEL | HAIFA | HAIFA |
| 118 | SOROKA MEDICAL CENTER; ONCOLOGY DEPT | DAVID GEFFEN | ISRAEL | BEER SHEVA | BEER SHEVA |
| 119 | SOURASKY / ICHILOV HOSPITAL; DEPT. OF ONCOLOGY | MOSHE INBAR | ISRAEL | TEL AVIV | TEL AVIV |
| 120 | ASSAF HAROFEH; ONCOLOGY | ELLA EVRON | ISRAEL | ZERIFIN | Zerifin |
| 121 | ARCISPEDALE S.ANNA; ONCOLOGIA MEDICA | ANTONIO FRASSOLDATI | ITALY | Veneto | Cona (FE) |
| 122 | Azienda Ospedaliera Papa Giovanni XXIII;Oncologia Medica | CARLO TONDINI | ITALY | Lombardia | BERGAMO |
| 123 | Azienda Ospedaliera San Giuseppe Moscati | CESARE GRIDELLI | ITALY | Campania | Avellino |
| 124 | AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI;S.C. ONCOLOGIA MEDICA 1 | FRANCESCO DI COSTANZO | ITALY | Toscana | FIRENZE |
| 125 | AZIENDA OSPEDALIERO-UNIVERSITARIA DIPARTIMENTO INTERAZIENDALE DI ONCOLOGIA | FABIO PUGLISI | ITALY | Friuli-Venezia Giulia | UDINE |
| 126 | Azienda USL di Ravenna; Unità Operativa di Oncologia Medica | Amelia Tienghi | ITALY | Emilia-Romagna | RAVENNA |
| 127 | AZ. OSP. OSPEDALE CIVILE; U.O. DI ONCOLOGIA MEDICA ED EMATOLOGIA | LUIGI CAVANNA | ITALY | Emilia-Romagna | PIACENZA |
| 128 | Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica | Alessandra Gennari | ITALY | Liguria | Genova |
| 129 | Fondazione Del Piemonte; Medical Oncology | Filippo Montemurro | ITALY | Piemonte | Candiolo |
| 130 | Irccs Istituto Europeo Di Oncologia (IEO) | Giuseppe Curigliano | ITALY | Lombardia | MILANO |
| 131 | Irccs Ospedale San Raffaele;Oncologia Medica | LUCA GIANNI | ITALY | Lombardia | MILANO |
| 132 | IRCCS POLICLINICO S. MATTEO - UNI PAVIA; CLINICA MEDICA I DIV. MED. INT. ONC. MEDICA E GASTROENT. | Donatella Grasso | ITALY | Lombardia | Pavia |
| 133 | OSPEDALE BELCOLLE DI VITERBO; ONCOLOGIA | LUCA MOSCETTI | ITALY | Lazio | VITERBO |
| 134 | OSPEDALE DEGLI INFERMI DI BIELLA; REPARTO ONCOLOGIA MEDICA | Alice Giacobino | ITALY | Piemonte | BIELLA |
| 135 | Ospedale Di Macerata; Oncologia | LUCIANO LATINI | ITALY | Marche | Macerata |
| 136 | OSPEDALE MAGGIORE DELLA CARITA; ONCOLOGIA MEDICA | OSCAR ALABISO | ITALY | Piemonte | NOVARA |
| 137 | OSPEDALE MATER SALUTIS; DEPT OF ONCOLOGY | ANDREA BONETTI | ITALY | Lombardia | LEGNAGO |
| 138 | OSPEDALE S. VINCENZO; ONCOLOGIA MEDICA | FRANCESCO FERRAU | ITALY | Sicilia | Taormina |
| 139 | OSPEDALI RIUNITI DI ANCONA; ONCOLOGY | STEFANO CASCINU | ITALY | Marche | ANCONA |
| 140 | American University of Beirut - Medical Center | Nagi El-Saghir | LEBANON | BEIRUT | Beirut |
| 141 | HOTEL DIEU DE FRANCE; ONCOLOGY | MARWAN GHOSN | LEBANON | BEIRUT | Beirut |
| 142 | Lithuanian University of Health. Sciences Kauno klinikos | ELONA JUOZAITYTE | LITHUANIA | KAUNAS | KAUNAS |
| 143 | UNI ONCOLOGY INST. ; CHEMO - RADIATION DEPT | EDUARDAS ALEKNAVICIUS | LITHUANIA | VILNIUS | VILNIUS |
| 144 | Cancerologia de Queretaro; Oncologia | ADRIANA DOMINGUEZ | MEXICO | Querétaro Arteaga | MEXICO |
| 145 | CENTRO MEDICO NACIONAL SIGLO XXI - IMSS; HOSPITAL DE ONCOLOGIA | Mario Aquilino Pérez Martínez | MEXICO | MEXICO CITY | MEXICO CITY |
| 146 | HOSPITAL GENERAL DE MéXICO; UNIDAD DE ONCOLOGIA | Jesus Miguel Lazaro Leon | MEXICO | MEXICO CITY | MEXICO CITY |
| 147 | HOSPITAL HMG COYOACAN | Alejandro Juarez Ramiro | MEXICO | DF | DF |
| 148 | IEM-FUCAM | FLAVIA MORALES-VASQUES | MEXICO | DF | DF |
| 149 | INSTITUTO NACIONAL DE CANCEROLOGIA; ONCOLOGY | Juan Matus Santos | MEXICO | MEXICO CITY | MEXICO CITY |
| 150 | INSTITUTO NACIONAL DE CIENCIAS MéDICAS Y DE LA NUTRICION ZUBIRáN | Yanin Chavarri Guerra | MEXICO | MEXICO CITY | MEXICO CITY |
| 151 | Medica Sur Centro Oncologico Integral | Jeronimo Rafael Rodriguez Cid | MEXICO | D.F. | D.F. |
| 152 | Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie | HASSAN ERRIHANI | MOROCCO | RABAT | Rabat |
| 153 | ALBERT SCHWEITZER ZIEKENHUIS; INWENDIGE GENEESKUNDE | J. VAN DEN BOSCH | NETHERLANDS | DORDRECHT | DORDRECHT |
| 154 | Catharina ZKHS; Inwendige Geneeskunde Afd. | L.J.C. van Warmerdam | NETHERLANDS | Eindhoven | Eindhoven |
| 155 | IKAZIA ZIEKENHUIS; INTERNE ONCOLOGIE | F.E. de Jongh | NETHERLANDS | ROTTERDAM | ROTTERDAM |
| 156 | MARTINI ZIEKENHUIS; DEPT OF INTERNAL MEDICINE | Annette van der Velden | NETHERLANDS | GRONINGEN | GRONINGEN |
| 157 | MC HAAGLANDEN, LOCATIE ANTONIUSHOVE; INTERNE GENEESKUNDE | H.M. OOSTERKAMP | NETHERLANDS | DEN HAAG | DEN HAAG |
| 158 | MEDISCH CENTRUM ALKMAAR | Susan Vrijaldenhoven | NETHERLANDS | ALKMAAR | ALKMAAR |
| 159 | TWEE STEDEN ZIEKENHUIS - LOCATIE TILBURG; INTERNE GENEESEKUNDE | H.T.J. ROERDINK | NETHERLANDS | TIBURG | Tilburg |
| 160 | Vie Curie | A.J. van de Wouw | NETHERLANDS | WENLO | Venlo |
| 161 | Hameed Latif Hospital; Department of Oncology | Aziz Zeba | PAKISTAN | LAHORE | Lahore |
| 162 | Shaukat Khanum Memorial Cancer Hospital; Department of Oncology | Siddiqi Neelum | PAKISTAN | LAHORE | Lahore |
| 163 | Shifa International Hospital; Department of Oncology | Kamran Rashid | PAKISTAN | ISLAMABAD | Islamabad |
| 164 | Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología | Milagros Cavero | PERU | LIMA | Lima |
| 165 | Instituto;Oncologico Miraflores | FERNANDO SALAS | PERU | LIMA | Lima |
| 166 | Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | MAREK WOJTUKIEWICZ | POLAND | BIALYSTOK | BIALYSTOK |
| 167 | Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piesi i Chirurgii Rekon. | Zbigniew Nowecki | POLAND | WARSZAWA | WARSZAWA |
| 168 | Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | TADEUSZ PIENKOWSKI | POLAND | OTWOCK | Otwock |
| 169 | Szpital Uniwersytecki w Krakowie, Oddzia？ Kliniczny Kliniki Onkologii | Krzysztof Krzemieniecki | POLAND | KRAKOW | Krakow |
| 170 | Wojewodzki Szpital Specjalistyczny im. M. Kopernika;Oddzial Chemioterapii | Ewa Kalinka-Warzocha | POLAND | LODZ | Lodz |
| 171 | ？wi？tokrzyskie Centrum Onkologii; | Jolanta Smok-Kalwat | POLAND | KIEICE | Kielce |
| 172 | Hospital da Luz; Departamento de Oncologia Medica | JOSE LUIS PASSOS COELHO | PORTUGAL | LISBOA | Lisboa |
| 173 | Hospital de Santa Maria; Servico de Oncologia Medica | Luis Costa | PORTUGAL | LISBOA | LISBOA |
| 174 | Hospital de Sao Joao; Servico de Oncologia | MARGARIDA DAMASCENO | PORTUGAL | PORTO | PORTO |
| 175 | Inst Portugues Oncologia Coim; Oncologia Medica | Gabriela Sousa | PORTUGAL | COIMBRA | Coimbra |
| 176 | IPO do Porto; Servico de Oncologia Medica | Ana Alexandra Ferreira | PORTUGAL | PORTO | PORTO |
| 177 | King Abdul Aziz Medical City, King Fahd National Guard; Oncology | OMALKHAIR ABULKHAIR | SAUDI ARABIA | RIYADH | RIYADH |
| 178 | KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTRE; ONCOLOGY | TAHER AL-TWEGIERI | SAUDI ARABIA | RIYADH | RIYADH |
| 179 | Institute for Oncology of Vojvodina | JASNA TRIFUNOVIC | SERBIA | SREMSKA KAMENICA | SREMSKA KAMENICA |
| 180 | Institute for Onc/Rad Serbia | Snezana Susnjar | SERBIA | BELGRADE | BELGRADE |
| 181 | INSTITUTE OF ONCOLOGY LJUBLJANA | Erika Matos | SLOVENIA | LJUBLJANA | LJUBLJANA |
| 182 | Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Antonio Gonzalez Martin | SPAIN | MADRID | MADRID |
| 183 | Clinica Universitaria de Navarra; Servicio de Oncologia | Marta Santisteban Eslava | SPAIN | NAVARRA | PAMPLONA |
| 184 | Complejo Asistencial Universitario De Burgos; Servicio de Oncologia | Maria Garcia Gonzalez | SPAIN | BURGOS | BURGOS |
| 185 | Complejo Asistencial Universitario de Leon; Servicio de Oncologia | Andres Garcia-Palomo Perez | SPAIN | LEON | LEON |
| 186 | Complejo Hospitalario de Orense; Servicio de Oncologia | Jesus Garcia Mata | SPAIN | ORENSE | ORENSE |
| 187 | Complejo Hospitalario Nuestra Se？ora de la Candelaria; Servicio de Oncologia | Pilar Lopez Alvarez | SPAIN | TENERIFE | SANTA CRUZ DE TENERIFE |
| 188 | Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Rafael Lopez Lopez | SPAIN | LA CORU？A | SANTIAGO DE COMPOSTELA |
| 189 | Fundacion Hospital de Alcorcon; Servicio de Oncologia | Clara Olier Garate | SPAIN | MADRID | Alcorcon |
| 190 | Fundacion Jimenez Diaz; Servicio de Oncologia | Yann Izarzugaza Peron | SPAIN | MADRID | MADRID |
| 191 | Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Antonio Llombart Cussac | SPAIN | VALENCIA | Valencia |
| 192 | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Ana Arance Fernandez | SPAIN | BARCELONA | Barcelona |
| 193 | Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Cesar Rodriguez Sanchez | SPAIN | SALAMANCA | SALAMANCA |
| 194 | Hospital Clinico Universitario de Valladolid; Servicio de Oncologia | Diego Soto de Prado | SPAIN | VALLADOLID | VALLADOLID |
| 195 | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Nuria Ribelles Entrena | SPAIN | MALAGA | Málaga |
| 196 | Hospital de Barbastro; Servicio de Oncologia | Jesus Florian Gerico | SPAIN | HUESCA | BARBASTRO |
| 197 | Hospital de Basurto; Servicio de Oncologia | Purificacion Martinez Del Prado | SPAIN | VIZCAYA | BILBAO |
| 198 | Hospital de Cabue？es; Servicio de Oncologia | Ignacio Pelaez Fernandez | SPAIN | ASTURIAS | Gijon |
| 199 | Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia | Salvador Saura Grau | SPAIN | LAS PALMAS | LAS PALMAS DE GRAN CANARIA |
| 200 | Hospital de Jerez de la Frontera; Servicio de Oncologia | M. Del Mar Gordon Santiago | SPAIN | CADIZ | JEREZ DE LA FRONTERA |
| 201 | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Agusti Barnadas Molins | SPAIN | BARCELONA | Barcelona |
| 202 | HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Laura Garcia Estevez | SPAIN | MADRID | Laura Garcia Estevez |
| 203 | Hospital de Navarra; Servicio de Oncologia | José Juan Illarramendi Ma？as | SPAIN | NAVARRA | José Juan Illarramendi Ma？as |
| 204 | Hospital de Rio Hortega; Servicio de Oncologia | Juan Carlos Torrego Garcia | SPAIN | VALLADOLID | Juan Carlos Torrego Garcia |
| 205 | Hospital de Sagunto; Servicio de Oncologia | Antonio Galan Brotons | SPAIN | VALENCIA | Antonio Galan Brotons |
| 206 | Hospital General de Elda; Servicio de Oncologia | Cristina Llorca Ferrandiz | SPAIN | ALICANTE | Cristina Llorca Ferrandiz |
| 207 | Hospital General Universitario de Guadalajara; Servicio de Oncologia | Alberto Arcediano Del Amo | SPAIN | GUADALAJARA | Alberto Arcediano Del Amo |
| 208 | Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia | Elisa Garcia Garre | SPAIN | MURCIA | Elisa Garcia Garre |
| 209 | Hospital Provincial de Castellon; Servicio de Oncologia | Eduardo Martinez De Due？as | SPAIN | CASTELLON | Eduardo Martinez De Due？as |
| 210 | Hospital Quiron Barcelona; Servicio de Oncologia | M. Jesus Vidal Losada | SPAIN | BARCELONA | M. Jesus Vidal Losada |
| 211 | Hospital Ramon y Cajal; Servicio de Oncologia | Noelia Martinez Ja？ez | SPAIN | MADRID | Noelia Martinez Ja？ez |
| 212 | Hospital San Pedro De Alcantara; Servicio de Oncologia | M. Helena Lopez De Ceballos | SPAIN | CACERES | M. Helena Lopez De Ceballos |
| 213 | Hospital Severo Ochoa; Servicio de Oncologia | M.Jose Echarri Gonzalez | SPAIN | MADRID | M.Jose Echarri Gonzalez |
| 214 | Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia | Gemma Vi？as Vilaro | SPAIN | GIRONA | Gemma Viaas Vilaro |
| 215 | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Eva Ciruelos Gil | SPAIN | MADRID | Eva Ciruelos Gil |
| 216 | Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Jose Angel Garcia Saenz | SPAIN | MADRID | Jose Angel Garcia Saenz |
| 217 | Hospital Universitario Dr. Peset | Rosa M. Llorente Domenech | SPAIN | VALENCIA | Rosa M. Llorente Domenech |
| 218 | Hospital Universitario La Paz; Servicio de Oncologia | Andres Redondo Sanchez | SPAIN | MADRID | Andres Redondo Sanchez |
| 219 | HOSPITAL UNIVERSITARIO SON ESPASES | Jesus Alarcon Company | SPAIN | ISLAS BALEARES | Jesus Alarcon Company |
| 220 | Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Jose Luis Alonso Romero | SPAIN | MURCIA | Jose Luis Alonso Romero |
| 221 | Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Salomon Menjon Beltran | SPAIN | GRANADA | Salomon Menjon Beltran |
| 222 | Hospital Universitario Virgen Macarena; Servicio de Oncologia | Luis De La Cruz Merino | SPAIN | SEVILLA | SEVILLA |
| 223 | Hospital Universitari Sant Joan de Reus; Servicio de Oncologia | Mireia Mele Olive | SPAIN | TARRAGONA | Reus |
| 224 | Centrallasarettet V？xj？, Onkologkliniken | Ulrik Narbe | SWEDEN | VAXJO | VAXJO |
| 225 | Centralsjukhuset Karlstad, Onkologkliniken | Kilian Bachmeier | SWEDEN | KARLSTAD | KARLSTAD |
| 226 | Gavle Sjukhus; Onkologiska Kliniken | Olga Del Val Munoz | SWEDEN | GAVLE | gavle |
| 227 | Sahlgrenska Universitetssjukhuset; Jubileumskliniken | Leif Klint | SWEDEN | GaTEBORG | GaTEBORG |
| 228 | Skanes University Hospital, Sk？nes Department of Onclology | NIKLAS LOMAN | SWEDEN | LUND | Lund |
| 229 | Vastmanlands sjukhus V？ster？s, Onkologkliniken | Helena Granstam Bjarneklett | SWEDEN | VaSTERaS | VaSTERaS |
| 230 | Akdeniz University Medical Faculty; Medical Oncology Department | Coskun Hasan Senol | TURKEY | ANTALYA | Antalya |
| 231 | Baskent Uni. Practice and Research Hospital; Medical Oncology | Ozgur Ozyilkan | TURKEY | ADANA | Adana |
| 232 | Ege University Medical Faculty; Medical Oncology Department | RUCHAN USLU | TURKEY | IZMIR | IZMIR |
| 233 | HACETTEPE UNI MEDICAL FACULTY HOSPITAL; ONCOLOGY DEPT | KADRI ALTUNDAG | TURKEY | ANKARA | ANKARA |
| 234 | Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Irfan Cicin | TURKEY | EDIRNE | EDIRNE |
| 235 | Kyiv City Clinical Oncological Center; Chemotherapy Department | Nataliia Voitko | UKRAINE | KIEV | Kiev |
| 236 | Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology | IGOR BONDARENKO | UKRAINE | Dnipropetrovsk Oblast | Dnipropetrovsk |
| 237 | State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department | Yaroslav Shparyk | UKRAINE | Lviv | Lviv |
| 238 | ZAPOROZHYE REGIONAL ONCOLOGY HOSPITAL; DEPT OF ONCOLOGY | ALEXEY KOVALEV | UKRAINE | Zaporozhye | ZAPOROZHYE |
| 239 | Tawam Hospital | Hassan Jaafar | UNITED ARAB EMIRATES | Al Ain | Al Ain |
| 240 | Addenbrookes Hospital; Dept of Oncology | Richard Baird | UNITED KINGDOM | England | Cambridge |
| 241 | Barts and the London NHS Trust. | CHRIS GALLAGHER | UNITED KINGDOM | England | LONDON |
| 242 | BEATSON WEST OF SCOTLAND CANCER CENTRE | Sophie Barrett | UNITED KINGDOM | Scottish | GLASGOW |
| 243 | Christie Hospital; Breast Cancer Research Office | ANDREW WARDLEY | UNITED KINGDOM | England | Manchester |
| 244 | Churchill Hospital | Nicola Levitt | UNITED KINGDOM | England | OXFORD |
| 245 | City Hospital NHS Trust | DAN REA | UNITED KINGDOM | England | BIRMINGHAM |
| 246 | DERRIFORD HOSPITAL; PLYMOUTH ONCOLOGY CENTRE | Stephen Kelly | UNITED KINGDOM | England | PLYMOUTH |
| 247 | Diana Princess of Wales Hosp. | Mohammed Butt | UNITED KINGDOM | England | Grimsby |
| 248 | Eastbourne District Hospital; Department of Pharmacy | Sarah Westwell | UNITED KINGDOM | England | EASTBOURNE |
| 249 | FREEMAN HOSPITAL; NORTHERN CENTRE FOR CANCER CARE | MARK VERRILL | UNITED KINGDOM | England | New Castle upon Tyne |
| 250 | HAIRMYRES HOSPITAL; ONCOLOGY DEPT | Grainne Dunn | UNITED KINGDOM | England | EAST KILBRIDE |
| 251 | HUDDERSFIELD ROYAL INFIRMARY | JOHNATHAN JOFFE | UNITED KINGDOM | England | HUDDERSFIELD |
| 252 | JAMES COOK UNI HOSPITAL | Alison Humphreys | UNITED KINGDOM | England | MIDDLESBOROUGH |
| 253 | Leeds Teaching Hosp NHS Trust;St James's Institute of Onc | TIMOTHY PERREN | UNITED KINGDOM | England | LEEDS |
| 254 | Macclesfield District General Hospital | Lisa Barraclough | UNITED KINGDOM | England | Macclesfield |
| 255 | Mount Vernon Cancer Centre | DAVID MILES | UNITED KINGDOM | England | Northwood, Essex |
| 256 | Musgrove Park Hospital | Mohini Varughese | UNITED KINGDOM | England | Somerset |
| 257 | Peterborough City Hospital | KAREN MCADAM | UNITED KINGDOM | England | Peterborough |
| 258 | Royal Cornwall Hospital | DUNCAN WHEATLEY | UNITED KINGDOM | England | Truro |
| 259 | ROYAL DERBY HOSPITAL | Prabir Chakraborti | UNITED KINGDOM | England | Derby |
| 260 | ROYAL FREE HOSPITAL; DEPT OF ONCOLOGY | ALISON JONES | UNITED KINGDOM | England | LONDON |
| 261 | Royal Marsden Hospital | Nicholas Turner | UNITED KINGDOM | England | London |
| 262 | Royal Surrey County Hospital | ROBERT LAING | UNITED KINGDOM | England | GUILDFORD |
| 263 | Royal United Hospital; Oncology Department | Mark Beresford | UNITED KINGDOM | England | Bath |
| 264 | Wishaw General Hospital | Jonathan Hicks | UNITED KINGDOM | England | Glasgow |
| 265 | The Royal Marsden Hospital | Nicholas Turner | UNITED KINGDOM | England | SUTTON |
| 266 | University Hospital of North Durham | Wendy Taylor | UNITED KINGDOM | England | Durham |
| 267 | Velindre Hospital | Peter J. BARRETT-LEE | UNITED KINGDOM | England | Cardiff |
| 268 | WALSGRAVE HOSPITAL | CHRIS POOLE | UNITED KINGDOM | England | COVENTRY |
| 269 | Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología | Cecilia Castillo | URUGUAY | MONTEVIDEO | Montevideo |
| 270 | Hospital Central De Las FF.AA.; Servicio De Oncologia | Robinson Rodriguez | URUGUAY | MONTEVIDEO | Montevideo |
| 271 | Hospital Pereira Rossell; Oncology Department | Isabel Alonso | URUGUAY | MONTEVIDEO | Montevideo |
| 272 | Centro Integral de Oncología | Gassan Yordi | VENEZUELA | CARACAS | CARACAS |
| 273 | Centro Médico Docente La Trinidad; Servicio de Gastroenterología | RAúLVERA | VENEZUELA | CARACAS | CARACAS |
| 274 | Instituto Oncológico Luis Razetti | Juan JoseRodriguez | VENEZUELA | CARACAS | CARACAS |
| 275 | ANTICANCER HOSPITAL AG. SAVAS ; 2ND DEPT. OF ONCOLOGY - INTERNAL MEDICINE | Georgios Koumakis | GREECE | ATHENS | ATHENS |
| 276 | Euromedical General Clinic of Thessaloniki; Oncology Department | Konstantinos Papazisis | GREECE | THESSALONIKI | Thessaloniki |
| 277 | HIPPOKRATIO HOSPITAL; 2ND INTERNAL MEDICINE | DIMITRIOS PECTASIDES | GREECE | ATHENS | Athens |
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 | 第三军医大学附属西南医院 | 同意 | 2013-04-15 |
| 2 | 哈尔滨医科大学附属肿瘤医院 | 修改后同意 | 2013-04-25 |
| 3 | 江苏省肿瘤医院 | 同意 | 2013-04-25 |
| 4 | 北京肿瘤医院 | 修改后同意 | 2013-05-14 |
| 5 | 天津市肿瘤医院 | 同意 | 2013-05-31 |
| 6 | 复旦大学附属肿瘤医院伦理委员会 | 修改后同意 | 2013-06-03 |
| 7 | 中山大学附属肿瘤医院 | 修改后同意 | 2013-06-27 |
| 8 | 西安交通大学医学院第一附属医院 | 同意 | 2013-06-28 |
| 9 | 第四军医大学西京医院 | 修改后同意 | 2013-07-24 |
| 10 | 复旦大学附属肿瘤医院伦理委员会 | 同意 | 2019-05-14 |
六、试验状态信息
1、试验状态
已完成
2、试验人数
| 目标入组人数 | 国内: 50 ； 国际: 1500 ； |
|---|---|
| 已入组人数 | 国内: 52 ； 国际: 1436 ； |
| 实际入组总人数 | 国内: 52 ； 国际: 1436 ； |
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：2013-06-21； 国际：2012-05-30； |
|---|---|
| 第一例受试者入组日期 | 国内：2013-06-21； 国际：2012-06-01； |
| 试验完成日期 | 国内：2019-12-11； 国际：2019-12-11； |
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