登记号
CTR20130572
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
非小细胞肺癌
试验通俗题目
比较Ipilimumab与安慰剂联合化疗治疗NSCLC的双盲试验
试验专业题目
比较Ipilimumab与安慰剂联合紫杉醇和卡铂用于Ⅳ期/复发性NSCLC受试者的疗效的随机、多中心、双盲、3期试验
试验方案编号
CA184-104
方案最近版本号
版本日期
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
李贤玲
联系人座机
8621-23218392
联系人手机号
联系人Email
liz.li@bms.com
联系人邮政地址
上海市南京西路1717号会德丰国际广场59楼
联系人邮编
200040
临床试验信息
试验分类
有效性
试验分期
III期
试验目的
本研究的目的是在非小细胞癌患者（仅鳞状细胞癌）中，观察接受Ipilimumab联合紫杉醇和卡铂治疗的患者的生存时间能否超过接受安慰剂联合紫杉醇和卡铂治疗的患者的生存期
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
N/A岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 非小细胞肺癌（NSCLC）-鳞状细胞癌
- 非小细胞肺癌(NSCLC)-鳞状细胞癌
- IV期或复发性NSCLC
- ECOG体能状态≤1分
- IV期或复发性NSCLC
- ECOG体能状态≤1分
排除标准
- 脑转移
- 自体免疫性疾病
- 脑转移
- 自体免疫性疾病
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:泰素
|
用法用量:静脉注射液；规格100 mg/瓶；静脉注射（IV）；用量：175 mg/m2，每3周第1天给药一次，连续使用6个周期
|
|
中文通用名:紫杉醇（BMS）
|
用法用量:注射液，规格5ml:30mg。按175 mg/m2静脉输液，须在3小时内完成输液。诱导期第1天开始每3周给药一次，最多6次剂量
|
|
中文通用名:卡铂（BMS）
|
用法用量:注射液，规格150mg/15ml/支。按AUC = 6静脉输液，须在30分钟内完成输液。诱导期第1天开始每3周给药一次，最多6次剂量
|
|
中文通用名:Ipilimumab注射液 （BMS）
|
用法用量:静脉注射液；规格：200mg/40mL/瓶；静脉注射（IV）；用量：10mg/kg，每3周一次，连续使用4个周期，之后每12周一次，直至疾病进展或发生不可接受的毒性
|
|
中文通用名:卡铂
|
用法用量:静脉注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC 6，每3周第1天给药一次，连续使用6个周期
|
|
中文通用名:Ipilimumab注射液 （BMS）
|
用法用量:规格200mg/40ml。用容量泵通过0.2至1.2um管线内滤器，按10 mg/kg静脉输液给药，必须在90min内完成输液，之后使用足量的生理盐水（约30 -50 mL）完全冲洗给药装置中的残留液体。诱导期每3周给药一次，最多4次。维持期每12周给药一次
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂注射液（研究中心自备）
|
用法用量:0.9%氯化钠注射液or 5%葡萄糖水溶液静脉输液，须在90分钟内完成输液，诱导期每3周给药一次，最多4次剂量。维持期每12周给药一次
|
|
中文通用名:安慰剂0.9%氯化钠注射液（研究中心自备）
|
用法用量:静脉注射液；规格：200mg/40mL/瓶；静脉注射（IV）；用量：10mg/kg；每3周一次，连续使用4个周期，之后每12周一次，直至疾病进展或发生不可接受的毒性
|
|
中文通用名:卡铂
|
用法用量:静脉注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC 6，每3周第1天给药一次，连续使用6个周期
|
|
中文通用名:紫杉醇（BMS）
|
用法用量:注射液，规格5ml:30mg。按175 mg/m2静脉输液，须在3小时内完成输液。诱导期第1天开始每3周给药一次，最多6次剂量
|
|
中文通用名:卡铂（BMS）
|
用法用量:注射液，规格150mg/15ml/支。按AUC = 6静脉输液，须在30分钟内完成输液。诱导期第1天开始每3周给药一次，最多6次剂量
|
|
中文通用名:泰素
|
用法用量:静脉注射液；规格100 mg/瓶；静脉注射（IV）；用量：175 mg/m2，每3周第1天给药一次，连续使用6个周期
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 总生存期 | 705死亡事件（观察到528例死亡事件后进行一次中期分析） | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 接受了至少一剂盲态研究治疗的所有随机分组受试者中的OS (OS2) | 研究开始后的42个月内 | 有效性指标 |
| 根据mWHO标准的最佳总体缓解率 | 研究开始后的42个月内 | 有效性指标 |
| 根据mWHO标准的无进展生存期 | 研究开始后的42个月内 | 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
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 张力 | 主任医师 | 86-20-87343458 | zhangli@sysucc.org.cn | 广州市东风东路651号 | 510060 | 中山大学肿瘤防治中心 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 广东省人民医院 | 中国 | 广东 | 广州 | |
| 中山大学肿瘤防治中心 | 张力 | 中国 | 广东 | 广州 |
| 天津市肿瘤医院 | 李凯 | 中国 | 天津 | 天津 |
| 北京协和医院 | 中国 | 北京 | 北京 | |
| 中国人民解放军第三〇七医院 | 刘晓晴 | 中国 | 北京 | 北京 |
| 军事医学科学院附属医院 | 中国 | 北京 | 北京 | |
| 中国医学科学院肿瘤医院 | 中国 | 北京 | 北京 | |
| 中国医学科学院肿瘤医院 | 石远凯 | 中国 | 北京 | 北京 |
| 北京大学肿瘤医院 | 中国 | 北京 | 北京 | |
| 北京大学肿瘤医院 | 王洁 | 中国 | 北京 | 北京 |
| 西安交通大学医学院第一附属医院 | 南克俊 | 中国 | 陕西 | 西安 |
| 西安交通大学医学院第一附属医院 | 中国 | 陕西 | 西安 | |
| 吉林省肿瘤医院 | 中国 | 吉林 | 长春 | |
| 吉林省肿瘤医院 | 程颖 | 中国 | 吉林 | 长春 |
| 同济大学附属上海市肺科医院 | 中国 | 上海 | 上海 | |
| 同济大学附属上海市肺科医院 | 周采存 | 中国 | 上海 | 上海 |
| 浙江大学医学院附属邵逸夫医院 | 中国 | 浙江 | 杭州 | |
| 浙江大学医学院附属邵逸夫医院 | 潘宏铭 | 中国 | 浙江 | 杭州 |
| 中国人民解放军第八一医院 | 中国 | 江苏 | 南京 | |
| 中国人民解放军第八一医院 | 秦叔逵 | 中国 | 江苏 | 南京 |
| 四川大学华西医院 | 中国 | 四川 | 成都 | |
| 中国人民解放军第四军医大学唐都医院 | 张贺龙 | 中国 | 陕西 | 西安 |
| 中国人民解放军第四军医大学唐都医院 | 中国 | 陕西 | 西安 | |
| 新疆医科大学附属肿瘤医院 | 刘春玲 | 中国 | 新疆 | 乌鲁木齐 |
| 中国人民解放军总医院 | 李方 | 中国 | 北京 | 北京 |
| 新疆医科大学附属肿瘤医院 | 中国 | 新疆 | 乌鲁木齐 | |
| 中国人民解放军总医院 | 中国 | 北京 | 北京 | |
| 中国医科大学附属第一医院 | 刘云鹏 | 中国 | 辽宁 | 沈阳 |
| 中国医科大学附属第一医院 | 中国 | 辽宁 | 沈阳 | |
| 苏州大学附属第一医院 | 陶敏 | 中国 | 江苏 | 苏州 |
| 浙江大学医学院附属第二医院 | 袁瑛 | 中国 | 浙江 | 杭州 |
| 苏州大学附属第一医院 | 中国 | 江苏 | 苏州 | |
| 浙江大学医学院附属第二医院 | 中国 | 浙江 | 杭州 | |
| 华中科技大学同济医学院附属协和医院 | 伍钢 | 中国 | 湖北 | 武汉 |
| 汕头大学医学院附属肿瘤医院 | 林雯 | 中国 | 广东 | 汕头 |
| 华中科技大学同济医学院附属协和医院 | 中国 | 湖北 | 武汉 | |
| 汕头大学医学院附属肿瘤医院 | 中国 | 广东 | 汕头 | |
| 江苏省肿瘤医院 | 陈嘉 | 中国 | 江苏 | 南京 |
| 上海交通大学附属胸科医院 | 韩宝惠 | 中国 | 上海 | 上海 |
| 江苏省肿瘤医院 | 中国 | 江苏 | 南京 | |
| 北京协和医院 | 王孟昭 | 中国 | 北京 | 北京 |
| 上海交通大学附属胸科医院 | 中国 | 上海 | 上海 | |
| 天津市肿瘤医院 | 中国 | 天津 | 天津 | |
| 广东省人民医院 | 吴一龙 | 中国 | 广东 | 广州 |
| Sanatorio Parque S.A. Privado | Ahualli, Alejandro | Argentina | CORDOBA | Cordoba |
| Centro Oncologico De Intergracion Regional | Arboit, Lino | Argentina | MENDOZA | Mendoza |
| Centro Esecializado Isis | Blajman, Cesar Raul | Argentina | SANTA FE | Santa Fe |
| Sanatorio Parque | Brown Arnold, Mario | Argentina | SANTA FE | Rosario |
| Centro Para La Atencion Integral Del Paciente Oncologico | Palazzo, Felipe Salvador | Argentina | TUCUMAN | San Miguel De Tucuman |
| Instituto Oncologico De Cordoba | Richardet, Martin Eduardo | Argentina | CORDOBA | Cordoba |
| Cer Instituto Medico | Varela, Mirta Susana | Argentina | BUENOS AIRES | Quilmes |
| North Coast Cancer | Boyce, Adam | Australia | Victoria | Lismore |
| Peninsula Oncology Centre | Ganju, Vinod | Australia | Victoria | Frankston |
| Austin Hospital | John, Thomas | Australia | Victoria | Heidelberg |
| Flinders Medical Centre | Karapetis, Christos Stelios | Australia | South Australia | Bedford Park |
| Box Hill Hospital | Parente, Phillip | Australia | Victoria | Box Hill |
| Border Medical Oncology | Underhill, Craig Richard | Australia | Victoria | Wodonga |
| Mount Medical Centre, Perth Oncology | Van Hazel, Guy | Australia | Western Australia | Perth |
| Krankenhaus Der Elisabethinen Linz GmbH | Bolitschek, Josef | Austria | Linz | Linz |
| Salzburger Landeskliniken Lkh | Greil, Richard | Austria | Salzburg | Salzburg |
| Allgemeines Krankenhaus Linz | Kropfmuller, Roland | Austria | Linz | Linz |
| Medizinische Universitaet Graz, | Olschewski, Horst | Austria | Graz | Graz |
| Centre Hospitalier Regional De La Citadelle | Bustin, Frederique | Belgium | Liege | Liege |
| Az Nikolaas | Deschepper, Koen | Belgium | Sint Niklaas | Sint Niklaas |
| Cliniques Universitaires Ucl De Mont-Godinne | Ocak, Sebahat | Belgium | Yvoir | Yvoir |
| Algemeen Stedelijk Ziekenhuis Aalst | Van Moorter, Lutgart | Belgium | Aalst | Aalst |
| Onze Lieve Vrouwenziekenhuis Campus Aalst | Vercauter, Piet | Belgium | Aalst | Aalst |
| Oncoclinic - Clinica De Oncologia E Atendimento De Urgencia | Alencar, Victor Hugo | Brazil | Ceara | Fortaleza |
| Liga Paranaense De Combate Ao Cancer Erasto Gaertner | De Oliveira, Fabricio Augusto | Brazil | Parana | Curitiba |
| Instituto Ribeirao Pretano De Combate Ao Cancer - Irpcc | Faccio, Adilson Aparecido | Brazil | Sao Paulo | Ribeirao Preto |
| Instituto De Oncologia Do Vale | Fernandes, Henrique Zanoni | Brazil | Sao Paulo | Sao Jose dos Campos |
| Instituto De Assistencia Medica Ao Servidor Publico Estadual | Gampel, Otavio | Brazil | Sao Paulo | Sao Paulo |
| Hospital Da Cidade | Lazaretti, Nicolas | Brazil | Rio Grande do Sul | Passo Fundo |
| Gram Grupo De Assistencia Medica E Prestacao De Servicos | Pereira, Jose Rodrigues | Brazil | Sao Paulo | Sao Paulo |
| Trymed-Biocancer Centro de Pesquisa Clinica S.A. | Portella, Marcos | Brazil | Belo Horizonte | Belo Horizonte |
| Fundacao Pio Xii Hosp Cancer De Barretos | Silva, Carlos Maciel | Brazil | Sao Paulo | Barretos |
| Hospital Sao Vicente De Paulo | Vacaro, Giovana | Brazil | Rio Grande Do Sul | Passo Fundo |
| Instituto Nacional Do Cancer - Inca | Victorino, Ana Paula | Brazil | Rio de janeiro | Rio de Janeiro |
| Clinionco | Vinholes, Jeferson | Brazil | Rio Grande Do Sul | Porto Alegre |
| Jewish General Hospital | Cohen, Victor | Canada | Qc | Montreal |
| Hopital Du Sacre-Coeur De Montreal | Cohen, Victor Diaconescu, Razvan | Canada | Qc | Montreal |
| Gerald Bronfman Centre | Hirsh, Vera | Canada | Qc | Montreal |
| Reg Cancer Program Of The Hopital De Sudbury Regional Hosp | Noble, Jonathan C.S | Canada | On | Sudbury |
| Lakeridge Health RS McLaughlin Durham Regional Cancer Centre | Wierzbicki, Rafal | Canada | Oshawa | Oshawa |
| Instituto Nacional Del Cancer | Aren Frontera, Osvaldo | Chile | METROPOLITANA | Santiago |
| Centro De Investigacion Clinica | Gonzalez Mella, Pablo | Chile | METROPOLITANA | Santiago |
| Instituto Oncologico Clinica Renaca | Gonzalez Mella, Pablo | Chile | VALPARAISO | Vina Del Mar |
| Clinica Santa Maria | Orellana Ulunque, Eric | Chile | METROPOLITANA | Santiago |
| Oncomedica S. A. | Gonzalez, Manuel | Colombia | CORDOBA | Monteria |
| Fundacion Cardiovascular De Colombia | Insuasty, Jesus S | Colombia | SANTANDER | Bucaramanga |
| Oncologos De Occidente S.A | Rojas, Gustavo Adolfo | Colombia | RISARALDA | Pereira |
| Nemocnice na Bulovce | Havel, Libor | Czech Republic | Prague 8 - Liben | Prague 8 - Liben |
| Oblastni Nemocnice Pribram, A.S. | Jakesova, Jitka | Czech Republic | Pribram | Pribram |
| Fn Motol, Pneumologicka Klinika Uk | Koubkova, Leona | Czech Republic | Praha 5 | Praha 5 |
| Nemocnice Znojmo, Odd. Radiacni A Klinicke Onkologie | Krizan, Karol | Czech Republic | Znojmo | Znojmo |
| MasarykovaNemocnice V Usti Nad Labem | Reiterer, Pavel | Czech Republic | Usti Nad Labem | Usti Nad Labem |
| Fakultni Nemocnice Ostrava | Roubec, Jaromir | Czech Republic | Ostrava | Ostrava |
| General University Hospital in Prague | Zemanova, Milada | Czech Republic | Prague 2 | Prague 2 |
| Herlev Hospital | Holm, Bente | Denmark | Herlev | Herlev |
| Odense University Hospital | Holmskov Hansen, Karin | Denmark | Odense | Odense |
| Naestved Hospital | Ingeberg, Steen | Denmark | Naestved | Naestved |
| Aalborg Hospital | Mcculloch, Tine | Denmark | Aalborg | Aalborg |
| Hillerod Hospital | Nielsen, Henrik Anker | Denmark | Hillerod | Hillerod |
| Hopital Nord | Barlesi, Fabrice | France | Marseille Cedex 20 | Marseille Cedex 20 |
| Chu Toulouse | Bigay-Game, Laurence | France | Toulouse Cedex 9 | Toulouse Cedex 9 |
| Centre Hospitalier Intercommunal de Creteil | Chouaid, Christos | France | Creteil | Creteil |
| Hopital De Brabois | Clement-Duchene, Christelle | France | Vandoeuvre-les-nancy | Vandoeuvre-les-nancy |
| Centre Francois Baclesse | Gervais, Radj | France | Caen | Caen |
| Chu De Poitiers | Lamour, Corinne | France | Poitiers | Poitiers |
| Chu Pontchaillou | Lena, Herve | France | Rennes Cedex 9 | Rennes Cedex 9 |
| Groupe Hospitalier Paris St-Joseph | Tredaniel, Jean | France | Paris | Paris |
| Augusta-Kranken-Anstalt Ggmbh | Behringer, Dirk | Germany | Bochum | Bochum |
| Klinikum Darmstadt GmbH | Bernhard, Helga | Germany | Darmstadt | Darmstadt |
| Universitatsklinikum Schleswig Holstein | Bohnet, Sabine | Germany | Lubeck | Lubeck |
| Klinikum Nuernberg | Brueckl, Wolfgang | Germany | Nuernberg | Nuernberg |
| Schwarzwald Baar Klinikum | Brugger, Wolfram | Germany | Villingen Schwenningen | Villingen Schwenningen |
| Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim | Chemaissani, Assaad | Germany | Koeln | Koeln |
| Asklepios Klinik Harburg Lungenabteilung | Eschbach, Corinna | Germany | Hamburg | Hamburg |
| Universitaetsklinikum Carl Gustav Carus | Folprecht, Gunnar | Germany | Dresden | Dresden |
| Klinikum Der Johann Wolfgang Goethe-Universitat | Gleiber, Wolfgang | Germany | Frankfurt am Main | Frankfurt am Main |
| Pius-Hospital Oldenburg | Griesinger, Frank | Germany | Oldenburg | Oldenburg |
| Friedrich Ebert Krankenhaus Gmbh | Held, Harald | Germany | Neumunster | Neumunster |
| Medizinische Universitaetsklinik Tuebingen | Kopp, Hans-Georg | Germany | Tuebingen | Tuebingen |
| Universitaetsklinikum Ulm | Lee, Mi Kyung | Germany | Ulm | Ulm |
| Krankenhaus Grosshansdorf Gmbh | Reck, Martin | Germany | Grosshansdorf | Grosshansdorf |
| Zentralklinik Bad Berka Gmbh | Schneider, Claus-Peter | Germany | Bad Berka | Bad Berka |
| Klinikum Bogenhausen | Schuetz, Martin | Germany | Muenchen | Muenchen |
| Lungenklinik Hemer | Serke, Momika | Germany | Hemer | Hemer |
| Krankenhaus Barmherzige Brueder Regensburg | Stauder, Heribert | Germany | Regensburg | Regensburg |
| Thoraxklinik-Heidelberg Ggmbh | Thomas, Michael | Germany | Heidelberg | Heidelberg |
| Asklepius Fachkliniken | Von Pawel, Joachim | Germany | Gauting | Gauting |
| Universitaetsmedizin Der Johannes Gutenberg-Universitaet | Wehler, Thomas | Germany | Mainz | Mainz |
| Klinikum Kassel Gmbh | Wolf, Martin | Germany | Kassel | Kassel |
| Pamela Youde Nethersole Eastern Hospital | Chan, Siu Hong | 中国 | 香港 | 香港 |
| Queen Mary Hospital | Ho, Chung Man James | 中国 | 香港 | 香港 |
| Tuen Mun Hospital | Lo, Sing Hung | 中国 | 香港 | 香港 |
| Queen Elizabeth Hospital | Yau, Stephen | 中国 | 香港 | 香港 |
| Matrai Gyogyintezet | Albert, Istvan | Hungary | Matrahaza | Matrahaza |
| Sopron Megyei Jogu Varos Erzsebet Oktato Korhaz | Bartfai, Zoltan | Hungary | Sopron | Sopron |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointez | Csoszi, Tibor | Hungary | Szolnok | Szolnok |
| Semmelweis Egyetem, Pulmonologiai Klinika | Losonczy, Gyorgy | Hungary | Budapest | Budapest |
| Veszprem Megyei Onkormanyzat Tudogyogyintezete | Medgyasszay, Balazs | Hungary | Farkasgyepu | Farkasgyepu |
| Orszagos Koranyi Tbc Es Pulmonologiai Intezet | Ostoros, Gyula | Hungary | Budapest | Budapest |
| Fejer Megyei Szent Gyorgy Korhaz | Papai-Szekely, Zsolt | Hungary | Szekesfehervar | Szekesfehervar |
| Pte Klinikai Kozpont 1.Sz. Belgyogyaszati Klinika, Pulmonolo | Sarosi, Veronika | Hungary | Pecs | Pecs |
| Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza | Somfay, Attila | Hungary | Deszk | Deszk |
| Josa Andras Oktatokorhaz | Szabo, Peter | Hungary | Nyiregyhaza | Nyiregyhaza |
| Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz | Sztancsik, Zsuzsanna | Hungary | Gyula | Gyula |
| Pest Megyei Tudogyogyintezet | Tolnay, Edina | Hungary | Torokbalint | Torokbalint |
| St James Hospital | Cuffe, Sinead | Ireland | Dublin | Dublin |
| GalWay University Hospital | Donnellan, Paul | Ireland | Galway | Galway |
| St Vincent's University Hospital | Hanrahan, Emer | Ireland | Dublin | Dublin |
| Adelaide Meath National Childrens Hospital | Mcdermott, Ray | Ireland | Dublin | Dublin |
| The Soroka University Medical Center | Ariad, Samuel | Israel | Beer Sheva | Beer Sheva |
| Assaf Harofeh Medical Center | Cyjon, Arnold | Israel | Zerifin | Zerifin |
| Meir Medical Center | Gottfried, Maya | Israel | Kfar Saba | Kfar Saba |
| Assuta Medical Center, Oncology Department | Jiveliouk, Irina | Israel | Tel-aviv | Tel-aviv |
| Oncology Institute, Kaplan Medical Center | Katsnelson, Rivka | Israel | Rehovot | Rehovot |
| Tel-Aviv Sourasky Medical Center | Merimsky, Ofer | Israel | Tel-aviv | Tel-aviv |
| Western Galilee Hospital- Nahariya | Nasrallah, Suheil | Israel | Nahariya | Nahariya |
| Oncology Department, Hadassah Medical Organization | Nechushtan, Hovav | Israel | Jerusalem | Jerusalem |
| Oncology Institute, Sheba Medical Center | Onn, Amir | Israel | Ramat-gan | Ramat-gan |
| The Davidoff Comprehensive Cancer Center | Stemmer, Salomon | Israel | Petah-tikva | Petah-tikva |
| Oncology Institute, Rambam Medical Center | Wollner, Mirjana | Israel | Haifa | Haifa |
| Ospedale Versilia | Amoroso, Domenico | Italy | Lucca | Lido Di Camaiore |
| Ospedale Campo Di Marte | Baldini, Editta | Italy | Lucca | Lucca |
| Azienda Ospedaliera Treviglio-Caravaggio | Barni, Sandro | Italy | Treviglio | Treviglio |
| Ospedale Civile Di Sondrio - Azienda Ospedaliera Della | Bertolini, Alessandro | Italy | Sondrio | Sondrio |
| Azienda Ospedaliera - Nuovo Ospedale San Gerardo | Bidoli, Paolo | Italy | Monza | Monza |
| Azienda Ospedaliera Di Perugia | Crino, Lucio | Italy | Perugia | Perugia |
| Ospedale G.Rummo | Daniele, Bruno | Italy | Benevento | Benevento |
| I.O.V. Istituto Oncologico Veneto Ircss | Favaretto, Adolfo | Italy | Padova | Padova |
| Azienda Ospedaliera Universitaria Senese | Maio, Michele | Italy | Siena | Siena |
| Policlinico S. Orsola Malpighi | Melotti, Barbara | Italy | Bologna | Bologna |
| Ospedale S.Maria | Roila, Fausto | Italy | Terni | Terni |
| Miyagi Cancer Center | Fukuhara, Tatsuro | Japan | Miyagi | Natori-shi |
| Aichi Cancer Center Central Hospital | Hida, Toyoaki | Japan | Aichi | Nagoya |
| Kanazawa University Hospital | Kasahara, Kazuo | Japan | ISHIKAWA | Kanazawa-shi |
| Kanagawa Cardiovascular and Respiratory Center | Kato, Terufumi | Japan | Kanagawa | Yokohama-Shi |
| National Cancer Center Hospital East | Ohmatsu, Hironobu | Japan | CHIBA | Kashiwa |
| Yokohama Municipal Citizen's Hospital/Respiratory Internal Medicine | Okamoto, Hiroaki | Japan | Kanagawa | Yokohama-Shi |
| National Hospital Organization Nagoya Medical Center | Saka, Hideo | Japan | Aichi | Nagoya-shi |
| National Nagoya Hospital | Saka, Hideo | Japan | Aichi | Nagoya-shi |
| Kyushu University Hospital | Takayama, Koichi | Japan | FUKUOKA | Fukuoka-shi |
| National Hospital Organization Kyushu Med Ctr | Takenoyama, Mitsuhiro | Japan | FUKUOKA | Fukuoka-shi |
| Osaka Medical College Hospital | Fujisaka, Yasuhito | Japan | OSAKA | Takatsuki-shi |
| Kansai Medical University Hirakata Hospital | Kurata, Takayasu | Japan | OSAKA | Hirakata-shi |
| Shizuoka Cancer Center | Naito, Tateaki | Japan | Shizuoka | Sunto-gun |
| Kinki University School Of Medicine | Nakagawa, Kazuhiko | Japan | OSAKA | Osaka-sayama-shi |
| Kawasaki Medical School Hospital | Oka, Mikio | Japan | OKAYAMA | Kurashiki City |
| Osaka City General Hospital | Takeda, Koji | Japan | OSAKA | Osaka-shi |
| Kurashiki Central Hospital | Yoshioka, Hiroshige | Japan | OKAYAMA | Kurashiki-shi |
| Yamaguchi Ube Medical Center | Chikamori, Kenichi | Japan | Yamaguchi | Ube-shi |
| Hokkaido Cancer Center | Harada, Masao | Japan | Sapporo, Hokkaido | Sapporo, Hokkaido |
| Tohoku University Hospital | Inoue, Akira | Japan | Sendai | Sendai |
| Hokkaido University Hospital | Kinoshita, Ichiro | Japan | Sapporo, Hokkaido | Sapporo, Hokkaido |
| Shikoku Cancer Center | Kozuki, Toshiyuki | Japan | Matsuyama, Ehime | Matsuyama, Ehime |
| Cancer Institute Hospital Of Jfcr | Nishio, Makoto | Japan | Tokyo | Koto-ku |
| Hyogo Cancer Center | Satouchi, Miyako | Japan | Akashi, Hyogo | Akashi, Hyogo |
| Sendai Kosei Hospital | Sugawara, Shunichi | Japan | Sendai, Miyagi | Sendai, Miyagi |
| National Cancer Center Hospital | Yamamoto, Noboru | Japan | Tokyo | Chuo-ku |
| Div Of Hematology & Oncology, Dept Of Med, Samsung Med Cntr | Ahn, Myung Ju | Republic of Korea | Seoul | Seoul |
| Gangnam Severance Hospital, Younsei University Health System | Cho, Jae Yong | Republic of Korea | Seoul | Seoul |
| Pusan National University Hospital | Choi, Young Jin | Republic of Korea | BUSAN | BUSAN |
| Chung-Ang University Hospital | Jang, Joung Soon | Republic of Korea | Seoul | Seoul |
| Seoul St. Mary'S Hospital, The Catholic University Of Korea | Kang, Jin-Hyoung | Republic of Korea | Seoul | Seoul |
| VHS Medical Center | Kim, Bong-Seong | Republic of Korea | Seoul | Seoul |
| Seoul National University Hospital | Kim, Dong Wan | Republic of Korea | Seoul | Seoul |
| The Catholic University Of Korea St. Vincent'S Hosp | Kim, Hoon Kyo | Republic of Korea | GYEONGGI-DO | Suwon-si |
| Severance Hospital, Yonsei University Health System | Kim, Joo-Hang | Republic of Korea | Seoul | Seoul |
| Asan Medical Center | Kim, Sang-We | Republic of Korea | Seoul | Seoul |
| Ajou University Hospital | Lee, Hyun Woo | Republic of Korea | GYEONGGI-DO | Suwon |
| Seoul National University Bundang Hospital | Lee, Jong Seok | Republic of Korea | Seongnam-si | Seongnam-si |
| Chungbuk National University Hospital | Lee, Ki Hyeong | Republic of Korea | Cheogju-si | Cheogju-si |
| National Cancer Center | Lee, Young Joo | Republic of Korea | GYEONGGI-DO | Goyang-si |
| Korea University Anam Hospital | Shin, Sang Won | Republic of Korea | Seoul | SEOUL |
| Keimyung University Dongsan Medical Center | Song, Hong Suk | Republic of Korea | Daegu | Daegu |
| Hospital Y Clinica Oca | Gonzalez-Perez, Jose Luis | Mexico | Nuevo Leon | Monterrey |
| Althian Research Management Center | Medina-Soto, Francisco Alejo | Mexico | Nuevo Leon | Monterrey |
| Hospital General De Occidente | Mondragon, Rogelio | Mexico | Jalisco | Zapopan |
| Centro Medico Dalinde | Villalobos-Valencia, Ricardo | Mexico | Distrito Federal | Mexico |
| Amphia Ziekenhuis ( Amphia Hospital) | Aerts, Joachim | Netherlands | Breda | Breda |
| Jeroen Bosch Ziekenhuis (Jeroen Bosch Hospital) | Biesma, Bonne | Netherlands | 's-Hertogenbosch | 's-Hertogenbosch |
| St. Jansdal Ziekenhuis | Gans, Steven S.J.M | Netherlands | Harderwijk | Harderwijk |
| St. Antonius Hospital | Herder, Judith G.J.M | Netherlands | Nieuwegein | Nieuwegein |
| Vu University Medical Center | Smit, Egbert F | Netherlands | Amsterdam | Amsterdam |
| Hospital Nacional Dos De Mayo/ Unidad De Quimioterapia | Chumbes, Mirna | Peru | Lima | Lima |
| Hospital Nacional Edgardo Rebagliati Martins | Figueroa, Alejandro | Peru | Lima | Lima |
| Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud | Giraldez, Jorge Becerra | Peru | Arequipa | Arequipa |
| Clinica Peruano Americana / Centro De Invest. Clin Trujillo | Zorrilla, Jose | Peru | LA LIBERTAD | Trujillo |
| Centrum Onkologii- Oddzial Kliniczny Onkologii | Chmielowska, Ewa | Poland | Bydgoszcz | Bydgoszcz |
| Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii,Transpl | Jassem, Jacek | Poland | Gdansk | Gdansk |
| Spz Gruzlicy I Chorob Pluc W Olsztynie | Kazarnowicz, Andrzej | Poland | Olsztyn | Olsztyn |
| Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie | Krzakowski, Maciej | Poland | Warszawa | Warszawa |
| Szpital Morski Im. Pck | Lesniewski-Kmak, Krzysztof | Poland | Gdynia | Gdynia |
| Wojewodzkie Centrum Onkologii Sp Zoz | Nowaczyk, Monika | Poland | Gdansk | Gdansk |
| Szpital Im. St. Leszczynskiego | Poborski, Wojciech | Poland | Katowice | Katowice |
| Oddzial Onkologii Klinicznej | Ramlau, Rodryg | Poland | Poznan | Poznan |
| Wojewodzki Szpital Zespolony W Elblagu | Ryniewicz- Zander, Iwona | Poland | Elblag | Elblag |
| Regionalny Szpital Specjalistyczny W Grudziadzu | Sadowska, Uszula | Poland | Grudziadz | Grudziadz |
| Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu | Sawrycki, Piotr | Poland | Torun | Torun |
| Specjalistyczny Szpital Im. Prof. Alfreda Sokolowskiego | Sawrycki, Piotr Serwatowski, Piotr | Poland | Szczecin | Szczecin |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy | Szczesna, Aleksandra | Poland | Otwock | Otwock |
| Inst Portugues De Oncologia De Lisboa Francisco Gentil,E.P.E | Almodovar, Teresa | Portugal | LISBOA | Lisboa |
| Centro Hospitalar De Entre O Douro E Vouga, Epe | Araujo, Antonio | Portugal | SANTA MARIA DA FEIRA | Santa Maria Da Feira |
| Centro Hospitalar De Coimbra | Barata, Fernando | Portugal | Coimbra | Coimbra |
| Centro Hospitalar De Vila Nova De Gaia/Espinho, Epe | Parente, Barbara | Portugal | Vila Nova De Gaia | Vila Nova De Gaia |
| Inst Portugues De Oncologia Do Porto Francisco Gentil, E.P.E | Soares, Marta | Portugal | PORTO | Porto |
| Centro Hospitalar Lisboa Norte, Epe - Hospital De Santa Mari | Teixeira, Maria Encarnacao | Portugal | LISBOA | Lisboa |
| Coltea Clinical Hospital | Aldea, Ciprian | Romania | Bucharest | Bucharest |
| Spitalul Judetean De Urgenta | Ganea, Doina Elena | Romania | Suceava | Suceava |
| Ianuli Med Consult Srl | Ianuli, Carmen-Hariclea G | Romania | Bucuresti | Bucuresti |
| Oncomed | Oprean, Cristina Marinela | Romania | Timisoara, Timis | Timisoara, Timis |
| Spitalul Judetean De Urgenta Sibiu | Patran, Monica | Romania | Sibiu | Sibiu |
| Sc Medisprof Srl | Udrea, Anghel Adrian | Romania | Cluj Napoca | Cluj Napoca |
| Johns Hopkins International Medical Centre | Chang, Alex Yuang-Chi | Singapore | Singapore | Singapore |
| Oncocare Cancer Centre | Leong, Swan | Singapore | Singapore | Singapore |
| Sahlgrenska Ostra Hospital | Bergman, Bengt | Sweden | Gothenburg | Gothenburg |
| Department Of Oncology | Johansson, Mikael | Sweden | Umea | Umea |
| Skanes University Hospital | Ohman, Ronny | Sweden | Lund | Lund |
| Dept Of Oncology | Tell, Roger | Sweden | Stockholm | Stockholm |
| Guz Republic Clinical Oncology Dispensary By Moh In Tatarst | Akhmetzyanov, Foat | Russian Federation | Kazan | Kazan |
| Guz Clinical Oncology Dispensary #1 | Davidenko, Irina | Russian Federation | Krasnodar | Krasnodar |
| State Institution Of Healthcare | Divnogortseva, Leniza | Russian Federation | Tula | Tula |
| Russian Scientific Center Of Rentgenoradiology | Dobrovolskaya, Natalia | Russian Federation | Moscow | Moscow |
| Chelyabinsk Regional Oncology Dispensary | Gladkov, Oleg | Russian Federation | Chelyabinsk | Chelyabinsk |
| Russian Oncology Research Center Named After Blokhin N.N. | Gorbunova, Vera | Russian Federation | Moscow | Moscow |
| City Clinical Oncology Dispensary | Karaseva, Nina | Russian Federation | St-Peterburg | St-Peterburg |
| Samara Regional Oncology Dispensary | Kopp, Mikhail | Russian Federation | Samara | Samara |
| Russian Oncological Research Center N.A. N.N. Blokhin Rams | Lichinitser, Mikhail | Russian Federation | Moscow | Moscow |
| Saint Petersburg State Medical University | Mosin, Igor | Russian Federation | St. Petersburg | St. Petersburg |
| Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarsta | Mukhametshina, Guzel | Russian Federation | Kazan | Kazan |
| NII Oncology n.a. N.N. Petrov | Protsenko, Svetlana | Russian Federation | Saint Petersburg | Saint Petersburg |
| FGBU Med. Radiol. Research Centre of Rus. Ministry of Health | Ragulin, Yury | Russian Federation | Obninsk | Obninsk |
| Fgu Hospital With Polyclinic | Severtsev, Alexey | Russian Federation | Moscow | Moscow |
| State Healthcare Inst. Pyatigorsk Oncology Dispensary | Vladimirov, Vladimir | Russian Federation | Pyatigorsk | Pyatigorsk |
| Department Of Radiation Oncology | Dalvie, Sameera | South Africa | WESTERN CAPE | Observatory |
| GVI Oncology Clinical Trials Unit | Jacobs, Conrad | South Africa | WESTERN CAPE | Panorama,cape Town |
| G V I Oncology, Rondebosch Oncology Centre | Harris, Jill | South Africa | WESTERN CAPE | Rondebosch |
| Hopelands Cancer Centre | Mall, Riaz | South Africa | KWA ZULU NATAL | Durban |
| Vaal Triangle Oncology-Alberts, Bouwer & Jordaan Inc. | Rens, Daniel | South Africa | EASTERN CAPE | Vereeniging |
| Centre Pluridisciplinaire D'Oncologie Centre Hosp Univ | Peters, Solange | Switzerland | Lausanne | Lausanne |
| Kantonsspital Winterthur | Pless, Miklos | Switzerland | Winterthur | Winterthur |
| Onkologiezentrum Thun-Berner Oberland Spital Sts Ag | Rauch, Daniel | Switzerland | Thun | Thun |
| University Hospital Basel | Zippelius, Alfred | Switzerland | Basel | Basel |
| Hospital Nuestra Senora. De Sonsoles | Ales Martinez, Jose Enrique | Spain | Avila | Avila |
| Hospital General Univ De Valencia | Camps Herrero, Carlos | Spain | Valencia | Valencia |
| Althaia Xarxa Assistencial De Manresa | Catot Tort, Silvia | Spain | Manresa | Manresa |
| Hospital Clinical Benidorm | Esquerdo Galiana, Gaspar | Spain | Benidorm-alicante | Benidorm-alicante |
| Hospital Santa Maria Nai | Firvida Perez, Jose | Spain | Ourense | Ourense |
| Hospital Arnau De Vilanova | Garcia-Sanchez, Jose | Spain | Valencia | Valencia |
| Hospital 12 De Octubre | Iglesias Docampo, Lara Carmen | Spain | Madrid | Madrid |
| Hospital De Mataro | Lianes, Pilar | Spain | Barcelona | Barcelona |
| Hospital De Cruces | Lopez-Vivanco, Guillermo | Spain | Vizcaya | Vizcaya |
| Hospital Provincial De Castellon | Sanchez Hernandez, Alfredo | Spain | Castellon | Castellon |
| Hospital Md Anderson | Sanchez Torres, Jose Miguel | Spain | Madrid | Madrid |
| Taichung Veterans General Hospital | Chang, Gee-Chen | 中国 | 台湾 | Taichung |
| China Medical University Hospital | Hsia, Te-Chun | 中国 | 台湾 | Taichung City |
| Chang Gung Medical Foundation, Linkou Branch | Kuo, Han-Pin | 中国 | 台湾 | Taoyuan |
| Changhua Christian Hospital | Li, Chien-Te | 中国 | 台湾 | Changhua |
| Chang Gung Medical Foundation-Chiayi Branch | Lu, Chang-Hsien | 中国 | 台湾 | Chiayi |
| Taipei Veterans General Hospital | Tsai, Chun-Ming | 中国 | 台湾 | Taipei |
| Chang Gung Medical Foundation-Kaohsiung Branch | Wang, Chin-Chou | 中国 | 台湾 | Kaohsiung |
| National Taiwan University Hospital | Yu, Chong-Jen | 中国 | 台湾 | Taipei |
| National Cancer Institute, Medical Oncology Unit | Arpornwirat, Wichit | Thailand | Bangkok | Bangkok |
| Holistic Center For Cancer Study And Care (Hocc-Psu) | Dechaphunkul, Arunee | Thailand | Songkla | Songkla |
| Phramongkutklao Hospital | Seetalarom, Kasan | Thailand | Bangkok | Bangkok |
| Division Of Medical Oncology Unit, Department Of Medicine | Srimuninnimit, Vichien | Thailand | Bangkok | Bangkok |
| Faculty Of Medicine, Chulalongkorn University | Sriuranpong, Virote | Thailand | Bangkok | Bangkok |
| Div. Of Medical Oncology, Dept. Of Medicine, Faculty Of Med | Thongprasert, Sumitra | Thailand | Chiang Mai | Chiang Mai |
| Royal Surrey County Hospital | Middleton, Gary | United Kingdom | Surrey | Guildford |
| Southampton University Hospital Nhs Trust | Ottensmeier, Christian | United Kingdom | Hampshire | Southampton |
| The Royal Marsden Hospital | Popat, Sanjay | United Kingdom | Greater London | London |
| Nottingham University Hospitals Nhs Trust | Potter, Vanessa | United Kingdom | Nottinghamshire | Nottingham |
| Ninewells Hospital And Medical School | Rankin, Elaine Mary | United Kingdom | Angus/forfarshire | Dundee |
| Royal Cornwall Hospital | Talbot, Toby | United Kingdom | Cornwall | Truro |
| Weston Park Hospital | Woll, Penella Jane | United Kingdom | Sheffield | Sheffield |
| Sharp Memorial Hospital | Bodkin, David | USA | CA | San Diego |
| Hematology & Med Oncology Of Southern Palm Beach County, Inc | Brito, Rogelio (Roger) A | USA | FL | Boynton Beach |
| Va Connecticut Healthcare System | Chao, Herta | USA | FL | Newington |
| Floyd Memorial Cancer Center Of Indiana | Chowhan, Naveed | USA | CT | New Albany |
| Lynn Cancer Institute Center For Hematology-Oncology | DeCesare, Teresa | USA | IN | Boca Raton |
| Integrated Community Oncology Network | Dees, Iii, Morris | USA | FL | Jacksonville |
| Indiana University Cancer Center | Einhorn, Lawrence | USA | FL | Indianapolis |
| Quincy Medical Group | El-Khoury, Christian | USA | IL | Quincy |
| University Of Illinois At Chicago Medical Center | Feldman, Lawrence | USA | IL | Chicago |
| Southern Illinois University School Of Medicine | Khan, Aziz-Ur-Rehman | USA | IL | Springfield |
| Orchard Healthcare Research Inc. | Oliff, Ira Anton | USA | IL | Skokie |
| St. Francis Hospital & Health Centers | Slaughter, Michael | USA | IN | Beech Grove |
| Clinical Research Alliance, Inc. | Arena, Francis P | USA | NY | Lake Success |
| Syracuse Va Medical Center | Gajra, Ajeet | USA | NY | Syracuse |
| Kentucky Cancer Clinic | Ghazal, Hassan H | USA | KY | Hazard |
| Norton Cancer Institute | Harandi, Amir | USA | KY | Louisville |
| Durham Va Medical Center | Kelley, Michael | USA | NC | Durham |
| Piedmont Hematology Oncology Associates, Pllc | Paschold, Eugene H | USA | NC | Winston Salem |
| Duke University Medical Center | Potti, Anil | USA | NC | Butner |
| Carolina Biooncology Institute | Powderly Ii,, John D | USA | NC | Huntersville |
| Presbyterian Hospital Cancer Research | Reiling, Richard | USA | NC | Charlotte |
| Montgomery Cancer Center | Zaydan, Muhammad-Ali | USA | KY | Mount Sterling |
| Washington University School Of Medicine | Baggstrom, Maria | USA | MO | Saint Louis |
| Oklahoma Oncology And Hematology, Pc Dba | Buck, Steven C | USA | OK | Tulsa |
| Singing River Health System | Clarkson, James | USA | MS | Pascagoula |
| University Of Minnesota | Dudek, Arkadiusz Z | USA | MN | Minneapolis |
| Gabrail Cancer Center Research | Gabrail, Nashat Y | USA | OH | Dover |
| Warren Cancer Research Foundation | Lynch, Joseph | USA | OK | Tulsa |
| Kansas City Cancer Centers -South | Pendergrass, Kelly | USA | MO | Kansas City |
| Dartmouth-Hitchcock Medical Center | Rigas, James | USA | NH | Lebanon |
| St Joseph Mercy Hospital | Stella, Philip | USA | MI | Ann Arbor |
| Tennessee Cancer Specialists | Dobbs, Tracy W | USA | TN | Knoxville |
| Associated in Oncology and Hematology | Gandhi, Jitendra | USA | TN | Chattanooga |
| Cancer Center Of The Carolinas | Gluck, William | USA | SC | Easley |
| Cancer Center At Cookeville Regional Medical Center | Jacquin, Paul N | USA | TN | Cookeville |
| Thompson Oncology Group | Mccachren Jr., Samuel S | USA | TN | Knoxville |
| Providence Regional Med Cntr Everett/Cancer Partnership | Saikaly, Elie | USA | WA | Everett |
| Texas Oncology, PA - South Austin Cancer Center | Uyeki, James | USA | TX | Austin |
| Wjb Dorn Va Medical Center | Wallam, Mohammed | USA | SC | Columbia |
| Blue Ridge Cancer Care | Goldschmidt, Jr., Jerome H | USA | VA | Salem |
| Guthrie Clinic, Ltd | Lash, Bradley | USA | PA | Sayre |
| Wisconsin Institutes for Medical Research | Leal, Ticiana | USA | WI | Madison |
| Kaiser Permanente Northwest Region | Rarick, Mark Urban | USA | OR | Portland |
| Cancer Outreach Associates, Pc | Swan, Jr., Forrest | USA | VA | Abingdon |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 中山大学肿瘤防治中心伦理委员会 | 同意 | 2013-07-07 |
| 中山大学肿瘤防治中心伦理委员会 | 同意 | 2014-08-15 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 80 人；
国际: 920 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 48 人 ；
国际: 923 人；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2013-09-03；
国际：2011-08-22；
试验终止日期
国内：2015-12-14；
国际：2016-12-09；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
