帕妥珠单抗注射液 |已完成

登记号
CTR20130952
相关登记号
曾用名
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
试验通俗题目
帕妥珠单抗HER2阳性晚期乳腺癌安全性研究
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
试验方案编号
MO28047 (5.0版)
方案最近版本号
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

申请人信息

申请人名称
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

临床试验信息

试验分类
安全性
试验分期
其它-新版
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
随机化
非随机化
盲法
开放
试验范围
国际多中心试验
设计类型
单臂试验
年龄
18岁(最小年龄)至 N/A岁(最大年龄)
性别
男+女
健康受试者
入选标准
  • 签署了经过相关的机构评审委员会(IRB)或独立伦理委员会(IEC)审批的书面知情同意。
  • 男性或女性患者,年龄18岁或以上。
  • 组织学或细胞学确诊并记录在案的乳腺腺癌,伴不可能根治性切除的转移性疾病或 局部复发病灶。
  • 根据当地实验室对原发肿瘤和/或者如果原发肿瘤不能获得时对转移部位的评估结果,呈HER2阳性(定义为免疫组化[IHC] 3+或原位杂交[ISH]阳性)(ISH阳性的定义为HER2基因拷贝数与CEP17信号的数量之比率为2.0或以上,或者对于单探针检测,HER2基因计数大于4)。
  • 至少有一个可测量的病灶,而且/或者可根据实体肿瘤疗效评价标准(RECIST)第1.1 版进行评估的不可测量疾病(附录5)。
  • 东部肿瘤合作组(ECOG)体能状态为0分、1分或2分。
  • 左心室射血分数(LVEF)至少50%。
  • 有怀孕可能性的女性(WOCBP;绝经前或者绝经后闭经不足12个月,以及尚未接受过手术绝育的女性),血清妊娠测试阴性。
  • 对于WOCBP以及伴侣为CBP而且性生活活跃的男性患者,同意在研究期间和研究治疗后至少7个月使用高度有效的非激素型避孕措施(例如手术绝育)或两种有效的非激素避孕措施(例如屏障避孕法结合杀精凝胶)(详细内容请参考第4.5.2.1节)。
  • 预期寿命至少有12周。
排除标准
  • 既往接受过针对转移性或局部复发疾病的全身性非激素抗癌疗法。注意:在进入研究之前,允许采用至多两线内分泌疗法治疗转移性或局部复发疾病,其中一种可与Everolimus联用。
  • 从辅助或新辅助全身性非激素治疗到复发之间的无疾病间期在6个月之内。
  • 既往以任何形式接受过已获批准或正在研究的抗HER2制剂作为乳腺癌的治疗,但作为辅助或新辅助治疗的曲妥珠单抗和/或拉帕替尼除外。
  • 在接受曲妥珠单抗和/或拉帕替尼作为辅助或新辅助治疗过程中,出现了疾病进展。
  • 既往辅助或新辅助治疗导致持续性2级或以上(NCI-CTC,第4.0版)血液毒性的病史。
  • 根据计算机断层扫描(CT)或核磁共振成像(MRI)评定,具有中枢神经系统 (CNS)转移的放射学证据但未获得良好控制的患者 (症状性或需要持续皮质类固醇 治疗(例如,地塞米松)加以控制 )。 注意:发生CNS 转移的患者在接受局部治疗 (放 射,手术等) 不加抗HER2治疗之后,如果其在筛选前3个月内病情稳定的话(根据研 究者评估),则允许其参与研究。
  • 目前有3级或以上的外周神经病变(NCI-CTC,第4.0版)。
  • 第一次应用研究药物(给药)之前算起的过去5年内有其它恶性疾病史,但宫颈原位 癌或者基底细胞癌除外。
  • 同时伴有可能导致本研究中研究药物禁忌使用的严重且不可控制或者使病人处于发 生治疗相关并发症高风险的合并疾病。
  • 器官功能不良,以下列实验室结果为证据: ? 绝对中性粒细胞计数<1,500细胞/mm3。 ? 血小板计数<100,000细胞/mm3。 ? 血红蛋白<9 g/dL。 ? 总胆红素大于正常上限(ULN;除非患者有记录在案的Gilbert综合征)。 ? AST (SGOT) 或 ALT (SGPT) >2.5 × ULN(有肝转移的患者> 5 × ULN)。 Pertuzumab—F. Hoffmann-La Roche Ltd 32/ MO28047中文方案版本 6.0,版本日期 2019年 01月 07日;基于英文方案版本 6.0,版本日期 2018年 11月 21日 ? 碱性磷酸酶水平> 2.5 ×ULN(有肝转移的患者> 5 × ULN,或者有骨转移的患 者>10 × ULN)。 ? 血清肌酐>2.0 mg/dL或177 μmol/L。 ? 国际标准化比率(INR)和激活部分凝血激酶时间(aPTT)或部分凝血激酶时间 (或PTT)>1.5 × ULN(除非正在使用治疗性抗凝疗法)。
  • 不受控制的高血压(收缩压>150 mmHg和/或舒张压>100 mmHg)或者具有临床意义(即活动性)的心血管疾病:第一次给药研究药物之前的6个月内有脑血管意外/中风或心肌梗死、不稳定心绞痛、纽约心脏协会(NYHA)II级或以上的充血性心力衰竭(CHF)、或需要药物治疗的严重心律失常。
  • 目前有已知的HIV、乙型肝炎病毒或丙型肝炎病毒感染。
  • 因晚期恶性疾病的并发症而在静息状态下有呼吸困难,或者其它需要持续氧气疗法的疾病。
  • 第一次使用研究药物(给药)之前的14天内有重大的外科手术或严重外伤,或者预 期在研究治疗的过程中需要重大手术。注意:如果研究过程中需要手术治疗,应允 许受试者最少恢复14天,之后方可开始后续帕妥珠单抗和曲妥珠单抗治疗入选之前 的7天内因感染而接受过静脉抗生素。
  • 目前长期使用(持续>3个月)每日的皮质激素治疗(剂量相当于或大于10 mg/天甲基 强的松龙), 但吸入性激素除外。
  • 已知对任何一种研究药物治疗或者对重组人源或人源化抗体的赋形剂过敏。
  • 第一次使用研究药物(给药)之前28天内有接受过任何研究性治疗史。
  • 根据研究者评估,不能够或不愿意遵守方案的要求。
  • 同时参加任何干预型的临床试验。

试验分组

试验药
名称 用法
中文通用名:帕妥珠单抗注射液
用法用量:注射剂,420mg(14ml)/瓶,静脉输液。在第一个治疗周期的第1天或第2天给予840mg,接下来在后续的每一个为期3周的周期的第1天或第 2天给予420mg。
中文通用名:曲妥珠单抗注射液
用法用量:注射剂,440mg(20ml)/瓶,静脉输液。将在第一个治疗周期的第1天或第2天,用负荷剂量8 mg/kg以静脉输液的形式给予曲妥珠单抗,接下来在后续的每个为期3周的周期的第1天或第2天给予6mg/kg;按照已获批准的当地产品信息和/或公认的临床实践指南。
对照药
名称 用法
中文通用名:无
用法用量:无

终点指标

主要终点指标
指标 评价时间 终点指标选择
NCI-CTCAE4.0AEs或SAEs的发生率和严重程度;CHF的发生率;研究过程中的LVEF;实验室检验异常 每年 安全性指标
次要终点指标
指标 评价时间 终点指标选择
PFS,OS,ORR,CBR,缓解的持续时间及出现缓解的时间 2018年6月 有效性指标
数据安全监察委员会(DMC)
为受试者购买试验伤害保险

研究者信息

姓名 学位 职称 电话 Email 邮政地址 邮编 单位名称
胡夕春 医学博士 主任医师 13816110335 xchu2009@hotmail.com 上海市-上海市-上海市徐汇区东安路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 胡夕春 中国 上海市 上海市
北京肿瘤医院 李惠萍 中国 北京市 北京市
江苏省肿瘤医院 冯继锋 中国 江苏省 南京市
中山大学附属肿瘤医院 王树森 中国 广东省 广州市
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
天津市肿瘤医院 佟仲生 中国 天津市 天津市
第三军医大学附属西南医院 姜军 中国 重庆市 重庆市
第四军医大学西京医院 李南林 中国 陕西省 西安市
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
CPMC; Service d'Oncologie Médicale KAMEL BOUZID ALGERIA ALGIERS Algiers
Centro Oncologico Riojano Integral (CORI) Luis Kaen ARGENTINA LA RIOJA La Rioja
Instituto de Oncología de Rosario Luis Fein ARGENTINA ROSARIO Rosario
AUSTIN AND REPATRIATION MEDICAL CENTRE; CANCER SERVICES Jacqui Thomson AUSTRALIA Victoria MELBOURNE
CANBERRA HOSPITAL; MEDICAL ONCOLOGY ROBIN STUART-HARRIS AUSTRALIA Australian Capital Territory CANBERRA
HOCA Chermside Nicole McCarthy AUSTRALIA Queensland Chermside
ROYAL MELBOURNE HOSPITAL; HEMATOLOGY AND MEDICAL ONCOLOGY RICHARD DE BOER AUSTRALIA Victoria PARKVILLE
Royal Prince Alfred Hospital; Medical Oncology JANE BEITH AUSTRALIA New South Wales Camperdown
LKH SALZBURG - UNIV. KLINIKUM SALZBURG; III. MEDIZINISCHE ABT. RICHARD GREIL AUSTRIA Salzburg Salzburg
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie HELLMUT SAMONIGG AUSTRIA Steiermark GRAZ
UNIVERSIT?TSKLINIK FüR FRAUENHEILKUNDE; KLINIK FüR GYN?KOLOGIE IV CHRISTIAN SINGER AUSTRIA WIEN WIEN
KH Der Barmherzigen Schwestern; Abteilung für Innere Medizin 1 ANDREAS PETZER AUSTRIA Upper Austria LINZ
UNIVERSITAIR ZIEKENHUIS BRUSSEL; ONCOLOGY JACQUES DE GREVE BELGIUM BRUXELLES BRUXELLES
UNIVERSITAIR ZIEKENHUIS; ONCOLOGIE - CANCEROLOGIE Veronique Cocquyt BELGIUM GENT GENT
U.Z. GASTHUISBERG; ONCOLOGY Hans Wildiers BELGIUM LEUVEN LEUVEN
CHU Sart Tilman GUY JERUSALEM BELGIUM LIEGE Liège
Hospital Amaral Carvalho Augusto BeatoCarlos BRAZIL SP Jau
Hospital das Clinicas - FMUSP Ribeirao Preto Jurandyr Moreira de Andrade BRAZIL SP Ribeirao Preto
Hospital Perola Byington Roberto Hegg BRAZIL SP Sao Paulo
Hospital Sao Jose Marceio Curz BRAZIL SP Sao Paulo
Hospital Sao Lucas - PUCRS Carlos Henrique Barrios BRAZIL RS Porto Alegre
HOSPITAL SIRIO LIBANES; CENTRO DE ONCOLOGIA Max Mano BRAZIL SP Sao Paulo
ONCOLOGISTAS ASSOCIADOS Gilberto Luiz Amorim BRAZIL RJ Rio de Janeiro
BCCA - VANCOUVER ISLAND CANCER CENTRE; ONCOLOGY Nicole Macpherson CANADA British Columbia VICTORIA
Capital Health; QEII HSC; Oncology DANIEL RAYSON CANADA Nova Scotia Halifax
CHUM - HOTEL DIEU DE MONTREAL Andre Robidoux CANADA Quebec MONTREAL
CROSS CANCER INSTITUTE ; DEPT OF MEDICAL ONCOLOGY ANIL ABRAHAM JOY CANADA Alberta EDMONTON
CSSS champlain - Charles-Le Moyne Susan Fox CANADA Quebec Greenfield Park
GRAND RIVER REGIONAL CANCER CENTRE Nadia Califaretti CANADA Ontario Kitchener
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology LAWRENCE PANASCI CANADA Quebec MONTREAL
SUNNYBROOK ODETTE CANCER CENTRE SUNIL VERMA CANADA Ontario Toronto
William Osler Health System Brampton Civic Hospital SANDEEP SEHDEV CANADA Ontario Brampton
HOSPITAL SOLCA PORTOVIEJO; ONCOLOGIA Miguel Cedeao ECUADOR QUITO PORTOVIEJO
HOSPITAL SOLCA QUITO; ONCOLOGIA Tannia Soria ECUADOR QUITO QUITO
Manial Specialized Hospital; Oncology AZEEM HAMDY ABDEL EGYPT CAIRO Cairo
NCI; ONCOLOGY DEPT Rabab Gaafar EGYPT CAIRO Cairo
North Estonia Medical Centre Foundation; Oncology Center Riina Kutner ESTONIA TALINN Tallinn
Tartu University Hospital; Clinic of Hematology and Oncology PEETER PADRIK ESTONIA TARTU Tartu
HELSINKI UNIVERSITY CENTRAL HOSPITAL; ONCOLOGY CLINICS Johanna Mattson FINLAND HELSINKI HELSINKI
SATAKUNTA CENTRAL HOSPITAL; ONCOLOGY OUTI SAARNI FINLAND PORI PORI
TAMPERE UNIVERSITY HOSPITAL; DEPT OF ONCOLOGY MINNA TANNER FINLAND TAMPERE Tampere
TURKU UNI CENTRAL HOSPITAL; ONCOLOGY CLINICS Johanna Ruohola FINLAND TURKU Turku
Centre Azureen De Cancerologie; Cons externes REMY LARGILLIER FRANCE MOUGINS MOUGINS
CENTRE CATALAN D' ONCOLOGIE Stephanie Catala FRANCE PERPIGNAN PERPIGNAN
CENTRE EUGENE MARQUIS; UNITE HUGUENIN Christophe Perrin FRANCE RENNES Rennes
Centre Georges Francois Leclerc; Oncologie 3 Bruno Coudert FRANCE DIJON Dijon
CENTRE HOSPITALIER FLEYRIAT; ONCOLOGIE/HEMATOLOGIE HUBERT ORFEUVRE FRANCE BOURG EN BRESSE BOURG EN BRESSE
Centre Leonard De Vinci;Chimiotherapie Virginie Pottier FRANCE DECHY Dechy
Centre Leon Berard; Departement Oncologie Medicale THOMAS BACHELOT FRANCE LYON Lyon
Centre Rene Huguenin; ONCOLOGIE GENETIQUE ETIENNE BRAIN FRANCE SAINT CLOUD Saint Cloud
Chp Saint Gregoire; Cancerologie Radiotherapie Xavier Artignan FRANCE SAINT GREGOIRE SAINT GREGOIRE
CLINIQUE CHENIEUX; ONCOLOGY Dominique Genet FRANCE LIMOGES Limoges
Institut D Oncologie Medical Mihaela Achille FRANCE STRASBOURG STRASBOURG
Clinique De L Europe; Radiotherapie Chimiotherapie MICHEL GOZY FRANCE AMIENS Amiens
Clinique Du Docteur Calabet; Cromg Olivier Bernard FRANCE AGEN Agen
Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie Jessica Grosjean FRANCE VALENCIENNES Valenciennes
CLINIQUE SAINTE MARGUERITE; ONCOLOGIE MEDICALE JEAN-FRANCOIS BERDAH FRANCE HYERES HYERES
Clinique Victor Hugo Hugues Bourgeois FRANCE LEMANS LeMans
Crlcc Paul Papin; Oncologie Medicale Paule Augereau FRANCE ANGERS Angers
Hopital Cochin; Unite Fonctionnelle D Oncologie JEROME ALEXANDRE FRANCE PARIS Paris
Ico Rene Gauducheau; Oncologie MARIO CAMPONE FRANCE SAINT HERBLAIN Saint Herblain
Institut Claudius Regaud; Departement Oncologie Medicale FLORENCE DALENC FRANCE TOULOUSE Toulouse
Institut Curie; Oncologie Medicale VERONIQUE DIERAS FRANCE PARIS Paris
INSTITUT PAOLI CALMETTES; ONCOLOGIE MEDICALE Anthony Goncalves FRANCE MARSEILLE Marseille
POLYCLINIQUE BORDEAUX NORD AQUITAINE; CHIMIOTHERAPIE RADIOTHERAPIE NADINE DOHOLLOU FRANCE BORDEAUX BORDEAUX
POLYCLINIQUE DE BLOIS; CHIMIOTHERAPIE AMBULATOIRE Philippe Laplaige FRANCE LA CHAUSSEE ST VICTOR La Chaussee St Victor
Polyclinique De Courlancy; Centre Radiotherapie Oncologie THOMAS FACCHINI FRANCE REIMS REIMS
Polyclinique Du Languedoc; Chimiotherapie Andre Mathieu FRANCE NARBONNE Narbonne
Hopital Prive Drome Ardeche; Hopital De Jour Hugues Barletta FRANCE GUIHERAND GRANGES Guilherand Granges
HOPITAL SAINT LOUIS; SERVICE ONCO THORACIQUE Luis Teixeira FRANCE PARIS PARIS
Agaplesion Diakonieklinikum Rotenburg Tobias Hesse GERMANY Hesse-Darmstadt ROTENBURG-WUEMME
EV. KRANKENHAUS BETHESDA; M?NCHENGLADBACH GGMBH Raquel von Schumann GERMANY Nordrhein-Westfalen M?nchengladbach
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding Hans- Joachim Lueck GERMANY Saxony Hannover
Gyn?kologicum Bremen Prof.Dr. Willibald Schr?der Willibald Schrader GERMANY Transdisciplinary programs Bremen
Klinikum am Bruderwald; Frauenklinik Roland Repp GERMANY Freistaat Bayern Bamberg
Klinikum Esslingen Klinik f. Frauenheilkunde und Geburtshilfe Thorsten Kuehn GERMANY Baden-Württemberg Esslingen
Klinikum rechts der Isar - Technische Uni München; Frauenklinik & Poliklinik Johannes Ettl GERMANY Freistaat Bayern München
Kreiskrankenhaus Torgau Abt.Gyn?kologie und Geburtshilfe Eike Simon GERMANY Saxony Torgau
Nationales Centrum für Tumorerkrankungen (NCT) Andreas Schneeweiss GERMANY Baden-Württemberg Heidelberg
Praxis Dr. Wagner Steffen Wagner GERMANY saarland Saarbruecken
Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe Bernd Christensen GERMANY Brandenburg Neuruppin
SRH Wald-Klinikum Gera Klinik f.Frauenheilkunde und Geburtshilfe DIRK-MICHAEL ZAHM GERMANY Freistaat Thüringen Gera
St.-Vincenz-Krankenhaus Frauenklinik Angelika Ober GERMANY LIMBURG Limburg
Uniklinik Tübingen; Frauenklinik Eva-Maria Grischke GERMANY Baden-Württemberg Tübingen
Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe Ingolf Juhasz-Bass GERMANY Hesse-Darmstadt Homburg/Saar
Universitatsklinikum Erlangen; Frauenklinik Michael Lux GERMANY Freistaat Bayern Erlangen
Universitatsklinikum Essen; Zentrum Für Frauenheilkunde Bahriye Aktas GERMANY Nordrhein-Westfalen Essen
Universitatsklinikum Hamburg-Eppendorf; Frauenklinik Volkmarv Mueller GERMANY HAMBURG Hamburg
Universitatsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe Achim Rody GERMANY Holstein Lübeck
AGAPLESION Markus-Krankenhaus) Fariba Khandan GERMANY Hesse-Darmstadt Frankfurt am Main
Papageorgiou General Hospital; Medical Oncology GEORGE FOUNTZILAS GREECE THESSALONIKI Thessaloniki
University General Hospital of Heraklion Dimitris Mavroudis GREECE GRETE Crete
UNIVERSITY HOSPITAL OF LARISSA; ONCOLOGY CHRISTOS PAPANDREOU GREECE LARISSA LARISSA
UNIVERSITY HOSPITAL OF PATRAS; MEDICAL ONCOLOGY HARALABOS KALOFONOS GREECE PATRAS PATRAS
QUEEN ELIZABETH HOSPITAL; CLINICAL ONCOLOGY ROGER NGAN HONG KONG HONG KONG HONG KONG
BORSOD-ABAUJ-ZEMPLEN MEGYEI KORHAZ ES EGYETEMI OKTATO KORHAZ; ONKOLOGIAI OSZTALY Janos Revesz HUNGARY MISKOLC Miskolc
DEBRECENI EGYETEM ORVOS ES EGESZSEGTUDOMANYI CENTRUM; ONKOLOGIAI TANSZEK Zsolt Horvath HUNGARY DEBRECEN DEBRECEN
FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET; ONKOLOGIAI OSZTALY GYORGY BODOKY HUNGARY BUDAPEST BUDAPEST
ORSZAGOS ONKOLOGIAL INTEZET; ONKOLOGIAI OSZTALY ISTVAN LANG HUNGARY BUDAPEST BUDAPEST
SZEGEDI TUDOMANYEGYETEM SZENT GYORGYI ALBERT ORVOS ES GYOGYSZERES; ONKOTERAPIAS KLINIKA Zsuzsanna Kahan HUNGARY SZEGED Szeged
Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai KATALIN BOER HUNGARY BUDAPEST BUDAPEST
Assuta Medical Centre; Oncology Irina Jiveliouk ISRAEL TEL AVIV Tel Aviv
CHAIM SHEBA MEDICAL CENTER; ONCOLOGY DEPT Shani Paluch-Shimon ISRAEL RAMAT-GAN Ramat-Gan
HADASSAH EIN KAREM HOSPITAL; ONCOLOGY DEPT Tamar PERETZ ISRAEL JERUSALEM JERUSALEM
KAPLAN MEDICAL CENTER; ONCOLOGY INST. NOA BEN BARUCH ISRAEL REHOVOT Rehovot
NAHARIYA HOSPITAL; ONCOLOGY Hadassah Goldberg ISRAEL NAHARIYA NAHARIYA
Rabin Medical Center; Oncology Dept SALOMON STEMMER ISRAEL PETACH TIKVA PETACH TIKVA
RAMBAM MEDICAL CENTER; ONCOLOGY GEORGETA FRIED ISRAEL HAIFA HAIFA
SOROKA MEDICAL CENTER; ONCOLOGY DEPT DAVID GEFFEN ISRAEL BEER SHEVA BEER SHEVA
SOURASKY / ICHILOV HOSPITAL; DEPT. OF ONCOLOGY MOSHE INBAR ISRAEL TEL AVIV TEL AVIV
ASSAF HAROFEH; ONCOLOGY ELLA EVRON ISRAEL ZERIFIN Zerifin
ARCISPEDALE S.ANNA; ONCOLOGIA MEDICA ANTONIO FRASSOLDATI ITALY Veneto Cona (FE)
Azienda Ospedaliera Papa Giovanni XXIII;Oncologia Medica CARLO TONDINI ITALY Lombardia BERGAMO
Azienda Ospedaliera San Giuseppe Moscati CESARE GRIDELLI ITALY Campania Avellino
AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI;S.C. ONCOLOGIA MEDICA 1 FRANCESCO DI COSTANZO ITALY Toscana FIRENZE
AZIENDA OSPEDALIERO-UNIVERSITARIA DIPARTIMENTO INTERAZIENDALE DI ONCOLOGIA FABIO PUGLISI ITALY Friuli-Venezia Giulia UDINE
Azienda USL di Ravenna; Unità Operativa di Oncologia Medica Amelia Tienghi ITALY Emilia-Romagna RAVENNA
AZ. OSP. OSPEDALE CIVILE; U.O. DI ONCOLOGIA MEDICA ED EMATOLOGIA LUIGI CAVANNA ITALY Emilia-Romagna PIACENZA
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica Alessandra Gennari ITALY Liguria Genova
Fondazione Del Piemonte; Medical Oncology Filippo Montemurro ITALY Piemonte Candiolo
Irccs Istituto Europeo Di Oncologia (IEO) Giuseppe Curigliano ITALY Lombardia MILANO
Irccs Ospedale San Raffaele;Oncologia Medica LUCA GIANNI ITALY Lombardia MILANO
IRCCS POLICLINICO S. MATTEO - UNI PAVIA; CLINICA MEDICA I DIV. MED. INT. ONC. MEDICA E GASTROENT. Donatella Grasso ITALY Lombardia Pavia
OSPEDALE BELCOLLE DI VITERBO; ONCOLOGIA LUCA MOSCETTI ITALY Lazio VITERBO
OSPEDALE DEGLI INFERMI DI BIELLA; REPARTO ONCOLOGIA MEDICA Alice Giacobino ITALY Piemonte BIELLA
Ospedale Di Macerata; Oncologia LUCIANO LATINI ITALY Marche Macerata
OSPEDALE MAGGIORE DELLA CARITA; ONCOLOGIA MEDICA OSCAR ALABISO ITALY Piemonte NOVARA
OSPEDALE MATER SALUTIS; DEPT OF ONCOLOGY ANDREA BONETTI ITALY Lombardia LEGNAGO
OSPEDALE S. VINCENZO; ONCOLOGIA MEDICA FRANCESCO FERRAU ITALY Sicilia Taormina
OSPEDALI RIUNITI DI ANCONA; ONCOLOGY STEFANO CASCINU ITALY Marche ANCONA
American University of Beirut - Medical Center Nagi El-Saghir LEBANON BEIRUT Beirut
HOTEL DIEU DE FRANCE; ONCOLOGY MARWAN GHOSN LEBANON BEIRUT Beirut
Lithuanian University of Health. Sciences Kauno klinikos ELONA JUOZAITYTE LITHUANIA KAUNAS KAUNAS
UNI ONCOLOGY INST. ; CHEMO - RADIATION DEPT EDUARDAS ALEKNAVICIUS LITHUANIA VILNIUS VILNIUS
Cancerologia de Queretaro; Oncologia ADRIANA DOMINGUEZ MEXICO Querétaro Arteaga MEXICO
CENTRO MEDICO NACIONAL SIGLO XXI - IMSS; HOSPITAL DE ONCOLOGIA Mario Aquilino Pérez Martínez MEXICO MEXICO CITY MEXICO CITY
HOSPITAL GENERAL DE MéXICO; UNIDAD DE ONCOLOGIA Jesus Miguel Lazaro Leon MEXICO MEXICO CITY MEXICO CITY
HOSPITAL HMG COYOACAN Alejandro Juarez Ramiro MEXICO DF DF
IEM-FUCAM FLAVIA MORALES-VASQUES MEXICO DF DF
INSTITUTO NACIONAL DE CANCEROLOGIA; ONCOLOGY Juan Matus Santos MEXICO MEXICO CITY MEXICO CITY
INSTITUTO NACIONAL DE CIENCIAS MéDICAS Y DE LA NUTRICION ZUBIRáN Yanin Chavarri Guerra MEXICO MEXICO CITY MEXICO CITY
Medica Sur Centro Oncologico Integral Jeronimo Rafael Rodriguez Cid MEXICO D.F. D.F.
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie HASSAN ERRIHANI MOROCCO RABAT Rabat
ALBERT SCHWEITZER ZIEKENHUIS; INWENDIGE GENEESKUNDE J. VAN DEN BOSCH NETHERLANDS DORDRECHT DORDRECHT
Catharina ZKHS; Inwendige Geneeskunde Afd. L.J.C. van Warmerdam NETHERLANDS Eindhoven Eindhoven
IKAZIA ZIEKENHUIS; INTERNE ONCOLOGIE F.E. de Jongh NETHERLANDS ROTTERDAM ROTTERDAM
MARTINI ZIEKENHUIS; DEPT OF INTERNAL MEDICINE Annette van der Velden NETHERLANDS GRONINGEN GRONINGEN
MC HAAGLANDEN, LOCATIE ANTONIUSHOVE; INTERNE GENEESKUNDE H.M. OOSTERKAMP NETHERLANDS DEN HAAG DEN HAAG
MEDISCH CENTRUM ALKMAAR Susan Vrijaldenhoven NETHERLANDS ALKMAAR ALKMAAR
TWEE STEDEN ZIEKENHUIS - LOCATIE TILBURG; INTERNE GENEESEKUNDE H.T.J. ROERDINK NETHERLANDS TIBURG Tilburg
Vie Curie A.J. van de Wouw NETHERLANDS WENLO Venlo
Hameed Latif Hospital; Department of Oncology Aziz Zeba PAKISTAN LAHORE Lahore
Shaukat Khanum Memorial Cancer Hospital; Department of Oncology Siddiqi Neelum PAKISTAN LAHORE Lahore
Shifa International Hospital; Department of Oncology Kamran Rashid PAKISTAN ISLAMABAD Islamabad
Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología Milagros Cavero PERU LIMA Lima
Instituto;Oncologico Miraflores FERNANDO SALAS PERU LIMA Lima
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej MAREK WOJTUKIEWICZ POLAND BIALYSTOK BIALYSTOK
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piesi i Chirurgii Rekon. Zbigniew Nowecki POLAND WARSZAWA WARSZAWA
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii TADEUSZ PIENKOWSKI POLAND OTWOCK Otwock
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii Krzysztof Krzemieniecki POLAND KRAKOW Krakow
Wojewodzki Szpital Specjalistyczny im. M. Kopernika;Oddzial Chemioterapii Ewa Kalinka-Warzocha POLAND LODZ Lodz
?wi?tokrzyskie Centrum Onkologii; Jolanta Smok-Kalwat POLAND KIEICE Kielce
Hospital da Luz; Departamento de Oncologia Medica JOSE LUIS PASSOS COELHO PORTUGAL LISBOA Lisboa
Hospital de Santa Maria; Servico de Oncologia Medica Luis Costa PORTUGAL LISBOA LISBOA
Hospital de Sao Joao; Servico de Oncologia MARGARIDA DAMASCENO PORTUGAL PORTO PORTO
Inst Portugues Oncologia Coim; Oncologia Medica Gabriela Sousa PORTUGAL COIMBRA Coimbra
IPO do Porto; Servico de Oncologia Medica Ana Alexandra Ferreira PORTUGAL PORTO PORTO
King Abdul Aziz Medical City, King Fahd National Guard; Oncology OMALKHAIR ABULKHAIR SAUDI ARABIA RIYADH RIYADH
KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTRE; ONCOLOGY TAHER AL-TWEGIERI SAUDI ARABIA RIYADH RIYADH
Institute for Oncology of Vojvodina JASNA TRIFUNOVIC SERBIA SREMSKA KAMENICA SREMSKA KAMENICA
Institute for Onc/Rad Serbia Snezana Susnjar SERBIA BELGRADE BELGRADE
INSTITUTE OF ONCOLOGY LJUBLJANA Erika Matos SLOVENIA LJUBLJANA LJUBLJANA
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia Antonio Gonzalez Martin SPAIN MADRID MADRID
Clinica Universitaria de Navarra; Servicio de Oncologia Marta Santisteban Eslava SPAIN NAVARRA PAMPLONA
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia Maria Garcia Gonzalez SPAIN BURGOS BURGOS
Complejo Asistencial Universitario de Leon; Servicio de Oncologia Andres Garcia-Palomo Perez SPAIN LEON LEON
Complejo Hospitalario de Orense; Servicio de Oncologia Jesus Garcia Mata SPAIN ORENSE ORENSE
Complejo Hospitalario Nuestra Se?ora de la Candelaria; Servicio de Oncologia Pilar Lopez Alvarez SPAIN TENERIFE SANTA CRUZ DE TENERIFE
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Rafael Lopez Lopez SPAIN LA CORU?A SANTIAGO DE COMPOSTELA
Fundacion Hospital de Alcorcon; Servicio de Oncologia Clara Olier Garate SPAIN MADRID Alcorcon
Fundacion Jimenez Diaz; Servicio de Oncologia Yann Izarzugaza Peron SPAIN MADRID MADRID
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia Antonio Llombart Cussac SPAIN VALENCIA Valencia
Hospital Clínic i Provincial; Servicio de Hematología y Oncología Ana Arance Fernandez SPAIN BARCELONA Barcelona
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia Cesar Rodriguez Sanchez SPAIN SALAMANCA SALAMANCA
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia Diego Soto de Prado SPAIN VALLADOLID VALLADOLID
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Nuria Ribelles Entrena SPAIN MALAGA Málaga
Hospital de Barbastro; Servicio de Oncologia Jesus Florian Gerico SPAIN HUESCA BARBASTRO
Hospital de Basurto; Servicio de Oncologia Purificacion Martinez Del Prado SPAIN VIZCAYA BILBAO
Hospital de Cabue?es; Servicio de Oncologia Ignacio Pelaez Fernandez SPAIN ASTURIAS Gijon
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia Salvador Saura Grau SPAIN LAS PALMAS LAS PALMAS DE GRAN CANARIA
Hospital de Jerez de la Frontera; Servicio de Oncologia M. Del Mar Gordon Santiago SPAIN CADIZ JEREZ DE LA FRONTERA
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Agusti Barnadas Molins SPAIN BARCELONA Barcelona
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Laura Garcia Estevez SPAIN MADRID Laura Garcia Estevez
Hospital de Navarra; Servicio de Oncologia José Juan Illarramendi Ma?as SPAIN NAVARRA José Juan Illarramendi Ma?as
Hospital de Rio Hortega; Servicio de Oncologia Juan Carlos Torrego Garcia SPAIN VALLADOLID Juan Carlos Torrego Garcia
Hospital de Sagunto; Servicio de Oncologia Antonio Galan Brotons SPAIN VALENCIA Antonio Galan Brotons
Hospital General de Elda; Servicio de Oncologia Cristina Llorca Ferrandiz SPAIN ALICANTE Cristina Llorca Ferrandiz
Hospital General Universitario de Guadalajara; Servicio de Oncologia Alberto Arcediano Del Amo SPAIN GUADALAJARA Alberto Arcediano Del Amo
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia Elisa Garcia Garre SPAIN MURCIA Elisa Garcia Garre
Hospital Provincial de Castellon; Servicio de Oncologia Eduardo Martinez De Due?as SPAIN CASTELLON Eduardo Martinez De Due?as
Hospital Quiron Barcelona; Servicio de Oncologia M. Jesus Vidal Losada SPAIN BARCELONA M. Jesus Vidal Losada
Hospital Ramon y Cajal; Servicio de Oncologia Noelia Martinez Ja?ez SPAIN MADRID Noelia Martinez Ja?ez
Hospital San Pedro De Alcantara; Servicio de Oncologia M. Helena Lopez De Ceballos SPAIN CACERES M. Helena Lopez De Ceballos
Hospital Severo Ochoa; Servicio de Oncologia M.Jose Echarri Gonzalez SPAIN MADRID M.Jose Echarri Gonzalez
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia Gemma Vi?as Vilaro SPAIN GIRONA Gemma Viaas Vilaro
Hospital Universitario 12 de Octubre; Servicio de Oncologia Eva Ciruelos Gil SPAIN MADRID Eva Ciruelos Gil
Hospital Universitario Clínico San Carlos; Servicio de Oncologia Jose Angel Garcia Saenz SPAIN MADRID Jose Angel Garcia Saenz
Hospital Universitario Dr. Peset Rosa M. Llorente Domenech SPAIN VALENCIA Rosa M. Llorente Domenech
Hospital Universitario La Paz; Servicio de Oncologia Andres Redondo Sanchez SPAIN MADRID Andres Redondo Sanchez
HOSPITAL UNIVERSITARIO SON ESPASES Jesus Alarcon Company SPAIN ISLAS BALEARES Jesus Alarcon Company
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia Jose Luis Alonso Romero SPAIN MURCIA Jose Luis Alonso Romero
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia Salomon Menjon Beltran SPAIN GRANADA Salomon Menjon Beltran
Hospital Universitario Virgen Macarena; Servicio de Oncologia Luis De La Cruz Merino SPAIN SEVILLA SEVILLA
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia Mireia Mele Olive SPAIN TARRAGONA Reus
Centrallasarettet V?xj?, Onkologkliniken Ulrik Narbe SWEDEN VAXJO VAXJO
Centralsjukhuset Karlstad, Onkologkliniken Kilian Bachmeier SWEDEN KARLSTAD KARLSTAD
Gavle Sjukhus; Onkologiska Kliniken Olga Del Val Munoz SWEDEN GAVLE gavle
Sahlgrenska Universitetssjukhuset; Jubileumskliniken Leif Klint SWEDEN GaTEBORG GaTEBORG
Skanes University Hospital, Sk?nes Department of Onclology NIKLAS LOMAN SWEDEN LUND Lund
Vastmanlands sjukhus V?ster?s, Onkologkliniken Helena Granstam Bjarneklett SWEDEN VaSTERaS VaSTERaS
Akdeniz University Medical Faculty; Medical Oncology Department Coskun Hasan Senol TURKEY ANTALYA Antalya
Baskent Uni. Practice and Research Hospital; Medical Oncology Ozgur Ozyilkan TURKEY ADANA Adana
Ege University Medical Faculty; Medical Oncology Department RUCHAN USLU TURKEY IZMIR IZMIR
HACETTEPE UNI MEDICAL FACULTY HOSPITAL; ONCOLOGY DEPT KADRI ALTUNDAG TURKEY ANKARA ANKARA
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Irfan Cicin TURKEY EDIRNE EDIRNE
Kyiv City Clinical Oncological Center; Chemotherapy Department Nataliia Voitko UKRAINE KIEV Kiev
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology IGOR BONDARENKO UKRAINE Dnipropetrovsk Oblast Dnipropetrovsk
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department Yaroslav Shparyk UKRAINE Lviv Lviv
ZAPOROZHYE REGIONAL ONCOLOGY HOSPITAL; DEPT OF ONCOLOGY ALEXEY KOVALEV UKRAINE Zaporozhye ZAPOROZHYE
Tawam Hospital Hassan Jaafar UNITED ARAB EMIRATES Al Ain Al Ain
Addenbrookes Hospital; Dept of Oncology Richard Baird UNITED KINGDOM England Cambridge
Barts and the London NHS Trust. CHRIS GALLAGHER UNITED KINGDOM England LONDON
BEATSON WEST OF SCOTLAND CANCER CENTRE Sophie Barrett UNITED KINGDOM Scottish GLASGOW
Christie Hospital; Breast Cancer Research Office ANDREW WARDLEY UNITED KINGDOM England Manchester
Churchill Hospital Nicola Levitt UNITED KINGDOM England OXFORD
City Hospital NHS Trust DAN REA UNITED KINGDOM England BIRMINGHAM
DERRIFORD HOSPITAL; PLYMOUTH ONCOLOGY CENTRE Stephen Kelly UNITED KINGDOM England PLYMOUTH
Diana Princess of Wales Hosp. Mohammed Butt UNITED KINGDOM England Grimsby
Eastbourne District Hospital; Department of Pharmacy Sarah Westwell UNITED KINGDOM England EASTBOURNE
FREEMAN HOSPITAL; NORTHERN CENTRE FOR CANCER CARE MARK VERRILL UNITED KINGDOM England New Castle upon Tyne
HAIRMYRES HOSPITAL; ONCOLOGY DEPT Grainne Dunn UNITED KINGDOM England EAST KILBRIDE
HUDDERSFIELD ROYAL INFIRMARY JOHNATHAN JOFFE UNITED KINGDOM England HUDDERSFIELD
JAMES COOK UNI HOSPITAL Alison Humphreys UNITED KINGDOM England MIDDLESBOROUGH
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc TIMOTHY PERREN UNITED KINGDOM England LEEDS
Macclesfield District General Hospital Lisa Barraclough UNITED KINGDOM England Macclesfield
Mount Vernon Cancer Centre DAVID MILES UNITED KINGDOM England Northwood, Essex
Musgrove Park Hospital Mohini Varughese UNITED KINGDOM England Somerset
Peterborough City Hospital KAREN MCADAM UNITED KINGDOM England Peterborough
Royal Cornwall Hospital DUNCAN WHEATLEY UNITED KINGDOM England Truro
ROYAL DERBY HOSPITAL Prabir Chakraborti UNITED KINGDOM England Derby
ROYAL FREE HOSPITAL; DEPT OF ONCOLOGY ALISON JONES UNITED KINGDOM England LONDON
Royal Marsden Hospital Nicholas Turner UNITED KINGDOM England London
Royal Surrey County Hospital ROBERT LAING UNITED KINGDOM England GUILDFORD
Royal United Hospital; Oncology Department Mark Beresford UNITED KINGDOM England Bath
Wishaw General Hospital Jonathan Hicks UNITED KINGDOM England Glasgow
The Royal Marsden Hospital Nicholas Turner UNITED KINGDOM England SUTTON
University Hospital of North Durham Wendy Taylor UNITED KINGDOM England Durham
Velindre Hospital Peter J. BARRETT-LEE UNITED KINGDOM England Cardiff
WALSGRAVE HOSPITAL CHRIS POOLE UNITED KINGDOM England COVENTRY
Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología Cecilia Castillo URUGUAY MONTEVIDEO Montevideo
Hospital Central De Las FF.AA.; Servicio De Oncologia Robinson Rodriguez URUGUAY MONTEVIDEO Montevideo
Hospital Pereira Rossell; Oncology Department Isabel Alonso URUGUAY MONTEVIDEO Montevideo
Centro Integral de Oncología Gassan Yordi VENEZUELA CARACAS CARACAS
Centro Médico Docente La Trinidad; Servicio de Gastroenterología RAúLVERA VENEZUELA CARACAS CARACAS
Instituto Oncológico Luis Razetti Juan JoseRodriguez VENEZUELA CARACAS CARACAS
ANTICANCER HOSPITAL AG. SAVAS ; 2ND DEPT. OF ONCOLOGY - INTERNAL MEDICINE Georgios Koumakis GREECE ATHENS ATHENS
Euromedical General Clinic of Thessaloniki; Oncology Department Konstantinos Papazisis GREECE THESSALONIKI Thessaloniki
HIPPOKRATIO HOSPITAL; 2ND INTERNAL MEDICINE DIMITRIOS PECTASIDES GREECE ATHENS Athens

伦理委员会信息

名称 审查结论 审查日期
第三军医大学附属西南医院 同意 2013-04-15
哈尔滨医科大学附属肿瘤医院 修改后同意 2013-04-25
江苏省肿瘤医院 同意 2013-04-25
北京肿瘤医院 修改后同意 2013-05-14
天津市肿瘤医院 同意 2013-05-31
复旦大学附属肿瘤医院伦理委员会 修改后同意 2013-06-03
中山大学附属肿瘤医院 修改后同意 2013-06-27
西安交通大学医学院第一附属医院 同意 2013-06-28
第四军医大学西京医院 修改后同意 2013-07-24
复旦大学附属肿瘤医院伦理委员会 同意 2019-05-14

试验状态信息

试验状态
已完成
目标入组人数
国内: 50 ; 国际: 1500 ;
已入组例数
国内: 52 ; 国际: 1436 ;
实际入组总例数
国内: 52  ; 国际: 1436 ;
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;
试验终止日期
国内:2019-12-11;     国际:2019-12-11;

临床试验结果摘要

版本号 版本日期

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