广州泰素III期临床试验-比较Ipilimumab与安慰剂联合化疗治疗NSCLC的双盲试验

登记号	CTR20130572	试验状态	已完成
申请人联系人	李贤玲	首次公示信息日期	2014-04-03
申请人名称	Bristol-Myers Squibb Company/ Bristol-Myers Squibb Holdings Pharma Ltd./ 百时美施贵宝（中国）投资有限公司

登记号	CTR20130572
相关登记号	暂无
药物名称	泰素
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
试验方案编号	CA184-104	方案最新版本号	暂无
版本日期:	暂无	方案是否为联合用药	企业选择不公示

申请人名称	1 2 3
联系人姓名	李贤玲	联系人座机	8621-23218392	联系人手机号	暂无
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

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

试验分类	有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

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	1 非小细胞肺癌（NSCLC）-鳞状细胞癌 2 非小细胞肺癌(NSCLC)-鳞状细胞癌 3 IV期或复发性NSCLC 4 ECOG体能状态≤1分 5 IV期或复发性NSCLC 6 ECOG体能状态≤1分
排除标准	1 脑转移 2 自体免疫性疾病 3 脑转移 4 自体免疫性疾病

试验药

序号 名称 用法 1 中文通用名:泰素 用法用量:静脉注射液；规格100mg/瓶；静脉注射（IV）；用量：175mg/m2，每3周第1天给药一次，连续使用6个周期 2 中文通用名:紫杉醇（BMS） 用法用量:注射液，规格5ml:30mg。按175mg/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 3 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 4 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 5 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：AUC6，每3周第1天给药一次，连续使用6个周期 6 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10mg/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30-50mL）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

序号 名称 用法 1 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or5%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 2 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 3 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：AUC6，每3周第1天给药一次，连续使用6个周期 4 中文通用名:紫杉醇（BMS） 用法用量:注射液，规格5ml:30mg。按175mg/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 5 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 6 中文通用名:泰素 用法用量:静脉注射液；规格100mg/瓶；静脉注射（IV）；用量：175mg/m2，每3周第1天给药一次，连续使用6个周期

主要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 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
次要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 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 2 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 3 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

1	姓名	张力	学位	暂无	职称	主任医师
	电话	86-20-87343458	Email	zhangli@sysucc.org.cn	邮政地址	广州市东风东路651号
	邮编	510060	单位名称	中山大学肿瘤防治中心

序号	机构名称	主要研究者	国家	省（州）	城市
1	中山大学肿瘤防治中心	张力	中国	广东	广州
2	天津市肿瘤医院	李凯	中国	天津	天津
3	中国人民解放军第三〇七医院	刘晓晴	中国	北京	北京
4	中国医学科学院肿瘤医院	石远凯	中国	北京	北京
5	北京大学肿瘤医院	王洁	中国	北京	北京
6	西安交通大学医学院第一附属医院	南克俊	中国	陕西	西安
7	吉林省肿瘤医院	程颖	中国	吉林	长春
8	同济大学附属上海市肺科医院	周采存	中国	上海	上海
9	浙江大学医学院附属邵逸夫医院	潘宏铭	中国	浙江	杭州
10	中国人民解放军第八一医院	秦叔逵	中国	江苏	南京
11	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
12	新疆医科大学附属肿瘤医院	刘春玲	中国	新疆	乌鲁木齐
13	中国人民解放军总医院	李方	中国	北京	北京
14	中国医科大学附属第一医院	刘云鹏	中国	辽宁	沈阳
15	苏州大学附属第一医院	陶敏	中国	江苏	苏州
16	浙江大学医学院附属第二医院	袁瑛	中国	浙江	杭州
17	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
18	汕头大学医学院附属肿瘤医院	林雯	中国	广东	汕头
19	江苏省肿瘤医院	陈嘉	中国	江苏	南京
20	上海交通大学附属胸科医院	韩宝惠	中国	上海	上海
21	北京协和医院	王孟昭	中国	北京	北京
22	广东省人民医院	吴一龙	中国	广东	广州
23	Sanatorio Parque S.A. Privado	Ahualli, Alejandro	Argentina	CORDOBA	Cordoba
24	Centro Oncologico De Intergracion Regional	Arboit, Lino	Argentina	MENDOZA	Mendoza
25	Centro Esecializado Isis	Blajman, Cesar Raul	Argentina	SANTA FE	Santa Fe
26	Sanatorio Parque	Brown Arnold, Mario	Argentina	SANTA FE	Rosario
27	Centro Para La Atencion Integral Del Paciente Oncologico	Palazzo, Felipe Salvador	Argentina	TUCUMAN	San Miguel De Tucuman
28	Instituto Oncologico De Cordoba	Richardet, Martin Eduardo	Argentina	CORDOBA	Cordoba
29	Cer Instituto Medico	Varela, Mirta Susana	Argentina	BUENOS AIRES	Quilmes
30	North Coast Cancer	Boyce, Adam	Australia	Victoria	Lismore
31	Peninsula Oncology Centre	Ganju, Vinod	Australia	Victoria	Frankston
32	Austin Hospital	John, Thomas	Australia	Victoria	Heidelberg
33	Flinders Medical Centre	Karapetis, Christos Stelios	Australia	South Australia	Bedford Park
34	Box Hill Hospital	Parente, Phillip	Australia	Victoria	Box Hill
35	Border Medical Oncology	Underhill, Craig Richard	Australia	Victoria	Wodonga
36	Mount Medical Centre, Perth Oncology	Van Hazel, Guy	Australia	Western Australia	Perth
37	Krankenhaus Der Elisabethinen Linz GmbH	Bolitschek, Josef	Austria	Linz	Linz
38	Salzburger Landeskliniken Lkh	Greil, Richard	Austria	Salzburg	Salzburg
39	Allgemeines Krankenhaus Linz	Kropfmuller, Roland	Austria	Linz	Linz
40	Medizinische Universitaet Graz,	Olschewski, Horst	Austria	Graz	Graz
41	Centre Hospitalier Regional De La Citadelle	Bustin, Frederique	Belgium	Liege	Liege
42	Az Nikolaas	Deschepper, Koen	Belgium	Sint Niklaas	Sint Niklaas
43	Cliniques Universitaires Ucl De Mont-Godinne	Ocak, Sebahat	Belgium	Yvoir	Yvoir
44	Algemeen Stedelijk Ziekenhuis Aalst	Van Moorter, Lutgart	Belgium	Aalst	Aalst
45	Onze Lieve Vrouwenziekenhuis Campus Aalst	Vercauter, Piet	Belgium	Aalst	Aalst
46	Oncoclinic - Clinica De Oncologia E Atendimento De Urgencia	Alencar, Victor Hugo	Brazil	Ceara	Fortaleza
47	Liga Paranaense De Combate Ao Cancer Erasto Gaertner	De Oliveira, Fabricio Augusto	Brazil	Parana	Curitiba
48	Instituto Ribeirao Pretano De Combate Ao Cancer - Irpcc	Faccio, Adilson Aparecido	Brazil	Sao Paulo	Ribeirao Preto
49	Instituto De Oncologia Do Vale	Fernandes, Henrique Zanoni	Brazil	Sao Paulo	Sao Jose dos Campos
50	Instituto De Assistencia Medica Ao Servidor Publico Estadual	Gampel, Otavio	Brazil	Sao Paulo	Sao Paulo
51	Hospital Da Cidade	Lazaretti, Nicolas	Brazil	Rio Grande do Sul	Passo Fundo
52	Gram Grupo De Assistencia Medica E Prestacao De Servicos	Pereira, Jose Rodrigues	Brazil	Sao Paulo	Sao Paulo
53	Trymed-Biocancer Centro de Pesquisa Clinica S.A.	Portella, Marcos	Brazil	Belo Horizonte	Belo Horizonte
54	Fundacao Pio Xii Hosp Cancer De Barretos	Silva, Carlos Maciel	Brazil	Sao Paulo	Barretos
55	Hospital Sao Vicente De Paulo	Vacaro, Giovana	Brazil	Rio Grande Do Sul	Passo Fundo
56	Instituto Nacional Do Cancer - Inca	Victorino, Ana Paula	Brazil	Rio de janeiro	Rio de Janeiro
57	Clinionco	Vinholes, Jeferson	Brazil	Rio Grande Do Sul	Porto Alegre
58	Jewish General Hospital	Cohen, Victor	Canada	Qc	Montreal
59	Hopital Du Sacre-Coeur De Montreal	Cohen, Victor Diaconescu, Razvan	Canada	Qc	Montreal
60	Gerald Bronfman Centre	Hirsh, Vera	Canada	Qc	Montreal
61	Reg Cancer Program Of The Hopital De Sudbury Regional Hosp	Noble, Jonathan C.S	Canada	On	Sudbury
62	Lakeridge Health RS McLaughlin Durham Regional Cancer Centre	Wierzbicki, Rafal	Canada	Oshawa	Oshawa
63	Instituto Nacional Del Cancer	Aren Frontera, Osvaldo	Chile	METROPOLITANA	Santiago
64	Centro De Investigacion Clinica	Gonzalez Mella, Pablo	Chile	METROPOLITANA	Santiago
65	Instituto Oncologico Clinica Renaca	Gonzalez Mella, Pablo	Chile	VALPARAISO	Vina Del Mar
66	Clinica Santa Maria	Orellana Ulunque, Eric	Chile	METROPOLITANA	Santiago
67	Oncomedica S. A.	Gonzalez, Manuel	Colombia	CORDOBA	Monteria
68	Fundacion Cardiovascular De Colombia	Insuasty, Jesus S	Colombia	SANTANDER	Bucaramanga
69	Oncologos De Occidente S.A	Rojas, Gustavo Adolfo	Colombia	RISARALDA	Pereira
70	Nemocnice na Bulovce	Havel, Libor	Czech Republic	Prague 8 - Liben	Prague 8 - Liben
71	Oblastni Nemocnice Pribram, A.S.	Jakesova, Jitka	Czech Republic	Pribram	Pribram
72	Fn Motol, Pneumologicka Klinika Uk	Koubkova, Leona	Czech Republic	Praha 5	Praha 5
73	Nemocnice Znojmo, Odd. Radiacni A Klinicke Onkologie	Krizan, Karol	Czech Republic	Znojmo	Znojmo
74	MasarykovaNemocnice V Usti Nad Labem	Reiterer, Pavel	Czech Republic	Usti Nad Labem	Usti Nad Labem
75	Fakultni Nemocnice Ostrava	Roubec, Jaromir	Czech Republic	Ostrava	Ostrava
76	General University Hospital in Prague	Zemanova, Milada	Czech Republic	Prague 2	Prague 2
77	Herlev Hospital	Holm, Bente	Denmark	Herlev	Herlev
78	Odense University Hospital	Holmskov Hansen, Karin	Denmark	Odense	Odense
79	Naestved Hospital	Ingeberg, Steen	Denmark	Naestved	Naestved
80	Aalborg Hospital	Mcculloch, Tine	Denmark	Aalborg	Aalborg
81	Hillerod Hospital	Nielsen, Henrik Anker	Denmark	Hillerod	Hillerod
82	Hopital Nord	Barlesi, Fabrice	France	Marseille Cedex 20	Marseille Cedex 20
83	Chu Toulouse	Bigay-Game, Laurence	France	Toulouse Cedex 9	Toulouse Cedex 9
84	Centre Hospitalier Intercommunal de Creteil	Chouaid, Christos	France	Creteil	Creteil
85	Hopital De Brabois	Clement-Duchene, Christelle	France	Vandoeuvre-les-nancy	Vandoeuvre-les-nancy
86	Centre Francois Baclesse	Gervais, Radj	France	Caen	Caen
87	Chu De Poitiers	Lamour, Corinne	France	Poitiers	Poitiers
88	Chu Pontchaillou	Lena, Herve	France	Rennes Cedex 9	Rennes Cedex 9
89	Groupe Hospitalier Paris St-Joseph	Tredaniel, Jean	France	Paris	Paris
90	Augusta-Kranken-Anstalt Ggmbh	Behringer, Dirk	Germany	Bochum	Bochum
91	Klinikum Darmstadt GmbH	Bernhard, Helga	Germany	Darmstadt	Darmstadt
92	Universitatsklinikum Schleswig Holstein	Bohnet, Sabine	Germany	Lubeck	Lubeck
93	Klinikum Nuernberg	Brueckl, Wolfgang	Germany	Nuernberg	Nuernberg
94	Schwarzwald Baar Klinikum	Brugger, Wolfram	Germany	Villingen Schwenningen	Villingen Schwenningen
95	Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim	Chemaissani, Assaad	Germany	Koeln	Koeln
96	Asklepios Klinik Harburg Lungenabteilung	Eschbach, Corinna	Germany	Hamburg	Hamburg
97	Universitaetsklinikum Carl Gustav Carus	Folprecht, Gunnar	Germany	Dresden	Dresden
98	Klinikum Der Johann Wolfgang Goethe-Universitat	Gleiber, Wolfgang	Germany	Frankfurt am Main	Frankfurt am Main
99	Pius-Hospital Oldenburg	Griesinger, Frank	Germany	Oldenburg	Oldenburg
100	Friedrich Ebert Krankenhaus Gmbh	Held, Harald	Germany	Neumunster	Neumunster
101	Medizinische Universitaetsklinik Tuebingen	Kopp, Hans-Georg	Germany	Tuebingen	Tuebingen
102	Universitaetsklinikum Ulm	Lee, Mi Kyung	Germany	Ulm	Ulm
103	Krankenhaus Grosshansdorf Gmbh	Reck, Martin	Germany	Grosshansdorf	Grosshansdorf
104	Zentralklinik Bad Berka Gmbh	Schneider, Claus-Peter	Germany	Bad Berka	Bad Berka
105	Klinikum Bogenhausen	Schuetz, Martin	Germany	Muenchen	Muenchen
106	Lungenklinik Hemer	Serke, Momika	Germany	Hemer	Hemer
107	Krankenhaus Barmherzige Brueder Regensburg	Stauder, Heribert	Germany	Regensburg	Regensburg
108	Thoraxklinik-Heidelberg Ggmbh	Thomas, Michael	Germany	Heidelberg	Heidelberg
109	Asklepius Fachkliniken	Von Pawel, Joachim	Germany	Gauting	Gauting
110	Universitaetsmedizin Der Johannes Gutenberg-Universitaet	Wehler, Thomas	Germany	Mainz	Mainz
111	Klinikum Kassel Gmbh	Wolf, Martin	Germany	Kassel	Kassel
112	Pamela Youde Nethersole Eastern Hospital	Chan, Siu Hong	中国	香港	香港
113	Queen Mary Hospital	Ho, Chung Man James	中国	香港	香港
114	Tuen Mun Hospital	Lo, Sing Hung	中国	香港	香港
115	Queen Elizabeth Hospital	Yau, Stephen	中国	香港	香港
116	Matrai Gyogyintezet	Albert, Istvan	Hungary	Matrahaza	Matrahaza
117	Sopron Megyei Jogu Varos Erzsebet Oktato Korhaz	Bartfai, Zoltan	Hungary	Sopron	Sopron
118	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointez	Csoszi, Tibor	Hungary	Szolnok	Szolnok
119	Semmelweis Egyetem, Pulmonologiai Klinika	Losonczy, Gyorgy	Hungary	Budapest	Budapest
120	Veszprem Megyei Onkormanyzat Tudogyogyintezete	Medgyasszay, Balazs	Hungary	Farkasgyepu	Farkasgyepu
121	Orszagos Koranyi Tbc Es Pulmonologiai Intezet	Ostoros, Gyula	Hungary	Budapest	Budapest
122	Fejer Megyei Szent Gyorgy Korhaz	Papai-Szekely, Zsolt	Hungary	Szekesfehervar	Szekesfehervar
123	Pte Klinikai Kozpont 1.Sz. Belgyogyaszati Klinika, Pulmonolo	Sarosi, Veronika	Hungary	Pecs	Pecs
124	Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza	Somfay, Attila	Hungary	Deszk	Deszk
125	Josa Andras Oktatokorhaz	Szabo, Peter	Hungary	Nyiregyhaza	Nyiregyhaza
126	Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz	Sztancsik, Zsuzsanna	Hungary	Gyula	Gyula
127	Pest Megyei Tudogyogyintezet	Tolnay, Edina	Hungary	Torokbalint	Torokbalint
128	St James Hospital	Cuffe, Sinead	Ireland	Dublin	Dublin
129	GalWay University Hospital	Donnellan, Paul	Ireland	Galway	Galway
130	St Vincent's University Hospital	Hanrahan, Emer	Ireland	Dublin	Dublin
131	Adelaide Meath National Childrens Hospital	Mcdermott, Ray	Ireland	Dublin	Dublin
132	The Soroka University Medical Center	Ariad, Samuel	Israel	Beer Sheva	Beer Sheva
133	Assaf Harofeh Medical Center	Cyjon, Arnold	Israel	Zerifin	Zerifin
134	Meir Medical Center	Gottfried, Maya	Israel	Kfar Saba	Kfar Saba
135	Assuta Medical Center, Oncology Department	Jiveliouk, Irina	Israel	Tel-aviv	Tel-aviv
136	Oncology Institute, Kaplan Medical Center	Katsnelson, Rivka	Israel	Rehovot	Rehovot
137	Tel-Aviv Sourasky Medical Center	Merimsky, Ofer	Israel	Tel-aviv	Tel-aviv
138	Western Galilee Hospital- Nahariya	Nasrallah, Suheil	Israel	Nahariya	Nahariya
139	Oncology Department, Hadassah Medical Organization	Nechushtan, Hovav	Israel	Jerusalem	Jerusalem
140	Oncology Institute, Sheba Medical Center	Onn, Amir	Israel	Ramat-gan	Ramat-gan
141	The Davidoff Comprehensive Cancer Center	Stemmer, Salomon	Israel	Petah-tikva	Petah-tikva
142	Oncology Institute, Rambam Medical Center	Wollner, Mirjana	Israel	Haifa	Haifa
143	Ospedale Versilia	Amoroso, Domenico	Italy	Lucca	Lido Di Camaiore
144	Ospedale Campo Di Marte	Baldini, Editta	Italy	Lucca	Lucca
145	Azienda Ospedaliera Treviglio-Caravaggio	Barni, Sandro	Italy	Treviglio	Treviglio
146	Ospedale Civile Di Sondrio - Azienda Ospedaliera Della	Bertolini, Alessandro	Italy	Sondrio	Sondrio
147	Azienda Ospedaliera - Nuovo Ospedale San Gerardo	Bidoli, Paolo	Italy	Monza	Monza
148	Azienda Ospedaliera Di Perugia	Crino, Lucio	Italy	Perugia	Perugia
149	Ospedale G.Rummo	Daniele, Bruno	Italy	Benevento	Benevento
150	I.O.V. Istituto Oncologico Veneto Ircss	Favaretto, Adolfo	Italy	Padova	Padova
151	Azienda Ospedaliera Universitaria Senese	Maio, Michele	Italy	Siena	Siena
152	Policlinico S. Orsola Malpighi	Melotti, Barbara	Italy	Bologna	Bologna
153	Ospedale S.Maria	Roila, Fausto	Italy	Terni	Terni
154	Miyagi Cancer Center	Fukuhara, Tatsuro	Japan	Miyagi	Natori-shi
155	Aichi Cancer Center Central Hospital	Hida, Toyoaki	Japan	Aichi	Nagoya
156	Kanazawa University Hospital	Kasahara, Kazuo	Japan	ISHIKAWA	Kanazawa-shi
157	Kanagawa Cardiovascular and Respiratory Center	Kato, Terufumi	Japan	Kanagawa	Yokohama-Shi
158	National Cancer Center Hospital East	Ohmatsu, Hironobu	Japan	CHIBA	Kashiwa
159	Yokohama Municipal Citizen's Hospital/Respiratory Internal Medicine	Okamoto, Hiroaki	Japan	Kanagawa	Yokohama-Shi
160	National Hospital Organization Nagoya Medical Center	Saka, Hideo	Japan	Aichi	Nagoya-shi
161	National Nagoya Hospital	Saka, Hideo	Japan	Aichi	Nagoya-shi
162	Kyushu University Hospital	Takayama, Koichi	Japan	FUKUOKA	Fukuoka-shi
163	National Hospital Organization Kyushu Med Ctr	Takenoyama, Mitsuhiro	Japan	FUKUOKA	Fukuoka-shi
164	Osaka Medical College Hospital	Fujisaka, Yasuhito	Japan	OSAKA	Takatsuki-shi
165	Kansai Medical University Hirakata Hospital	Kurata, Takayasu	Japan	OSAKA	Hirakata-shi
166	Shizuoka Cancer Center	Naito, Tateaki	Japan	Shizuoka	Sunto-gun
167	Kinki University School Of Medicine	Nakagawa, Kazuhiko	Japan	OSAKA	Osaka-sayama-shi
168	Kawasaki Medical School Hospital	Oka, Mikio	Japan	OKAYAMA	Kurashiki City
169	Osaka City General Hospital	Takeda, Koji	Japan	OSAKA	Osaka-shi
170	Kurashiki Central Hospital	Yoshioka, Hiroshige	Japan	OKAYAMA	Kurashiki-shi
171	Yamaguchi Ube Medical Center	Chikamori, Kenichi	Japan	Yamaguchi	Ube-shi
172	Hokkaido Cancer Center	Harada, Masao	Japan	Sapporo, Hokkaido	Sapporo, Hokkaido
173	Tohoku University Hospital	Inoue, Akira	Japan	Sendai	Sendai
174	Hokkaido University Hospital	Kinoshita, Ichiro	Japan	Sapporo, Hokkaido	Sapporo, Hokkaido
175	Shikoku Cancer Center	Kozuki, Toshiyuki	Japan	Matsuyama, Ehime	Matsuyama, Ehime
176	Cancer Institute Hospital Of Jfcr	Nishio, Makoto	Japan	Tokyo	Koto-ku
177	Hyogo Cancer Center	Satouchi, Miyako	Japan	Akashi, Hyogo	Akashi, Hyogo
178	Sendai Kosei Hospital	Sugawara, Shunichi	Japan	Sendai, Miyagi	Sendai, Miyagi
179	National Cancer Center Hospital	Yamamoto, Noboru	Japan	Tokyo	Chuo-ku
180	Div Of Hematology & Oncology, Dept Of Med, Samsung Med Cntr	Ahn, Myung Ju	Republic of Korea	Seoul	Seoul
181	Gangnam Severance Hospital, Younsei University Health System	Cho, Jae Yong	Republic of Korea	Seoul	Seoul
182	Pusan National University Hospital	Choi, Young Jin	Republic of Korea	BUSAN	BUSAN
183	Chung-Ang University Hospital	Jang, Joung Soon	Republic of Korea	Seoul	Seoul
184	Seoul St. Mary'S Hospital, The Catholic University Of Korea	Kang, Jin-Hyoung	Republic of Korea	Seoul	Seoul
185	VHS Medical Center	Kim, Bong-Seong	Republic of Korea	Seoul	Seoul
186	Seoul National University Hospital	Kim, Dong Wan	Republic of Korea	Seoul	Seoul
187	The Catholic University Of Korea St. Vincent'S Hosp	Kim, Hoon Kyo	Republic of Korea	GYEONGGI-DO	Suwon-si
188	Severance Hospital, Yonsei University Health System	Kim, Joo-Hang	Republic of Korea	Seoul	Seoul
189	Asan Medical Center	Kim, Sang-We	Republic of Korea	Seoul	Seoul
190	Ajou University Hospital	Lee, Hyun Woo	Republic of Korea	GYEONGGI-DO	Suwon
191	Seoul National University Bundang Hospital	Lee, Jong Seok	Republic of Korea	Seongnam-si	Seongnam-si
192	Chungbuk National University Hospital	Lee, Ki Hyeong	Republic of Korea	Cheogju-si	Cheogju-si
193	National Cancer Center	Lee, Young Joo	Republic of Korea	GYEONGGI-DO	Goyang-si
194	Korea University Anam Hospital	Shin, Sang Won	Republic of Korea	Seoul	SEOUL
195	Keimyung University Dongsan Medical Center	Song, Hong Suk	Republic of Korea	Daegu	Daegu
196	Hospital Y Clinica Oca	Gonzalez-Perez, Jose Luis	Mexico	Nuevo Leon	Monterrey
197	Althian Research Management Center	Medina-Soto, Francisco Alejo	Mexico	Nuevo Leon	Monterrey
198	Hospital General De Occidente	Mondragon, Rogelio	Mexico	Jalisco	Zapopan
199	Centro Medico Dalinde	Villalobos-Valencia, Ricardo	Mexico	Distrito Federal	Mexico
200	Amphia Ziekenhuis ( Amphia Hospital)	Aerts, Joachim	Netherlands	Breda	Breda
201	Jeroen Bosch Ziekenhuis (Jeroen Bosch Hospital)	Biesma, Bonne	Netherlands	's-Hertogenbosch	's-Hertogenbosch
202	St. Jansdal Ziekenhuis	Gans, Steven S.J.M	Netherlands	Harderwijk	Harderwijk
203	St. Antonius Hospital	Herder, Judith G.J.M	Netherlands	Nieuwegein	Nieuwegein
204	Vu University Medical Center	Smit, Egbert F	Netherlands	Amsterdam	Amsterdam
205	Hospital Nacional Dos De Mayo/ Unidad De Quimioterapia	Chumbes, Mirna	Peru	Lima	Lima
206	Hospital Nacional Edgardo Rebagliati Martins	Figueroa, Alejandro	Peru	Lima	Lima
207	Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud	Giraldez, Jorge Becerra	Peru	Arequipa	Arequipa
208	Clinica Peruano Americana / Centro De Invest. Clin Trujillo	Zorrilla, Jose	Peru	LA LIBERTAD	Trujillo
209	Centrum Onkologii- Oddzial Kliniczny Onkologii	Chmielowska, Ewa	Poland	Bydgoszcz	Bydgoszcz
210	Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii,Transpl	Jassem, Jacek	Poland	Gdansk	Gdansk
211	Spz Gruzlicy I Chorob Pluc W Olsztynie	Kazarnowicz, Andrzej	Poland	Olsztyn	Olsztyn
212	Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie	Krzakowski, Maciej	Poland	Warszawa	Warszawa
213	Szpital Morski Im. Pck	Lesniewski-Kmak, Krzysztof	Poland	Gdynia	Gdynia
214	Wojewodzkie Centrum Onkologii Sp Zoz	Nowaczyk, Monika	Poland	Gdansk	Gdansk
215	Szpital Im. St. Leszczynskiego	Poborski, Wojciech	Poland	Katowice	Katowice
216	Oddzial Onkologii Klinicznej	Ramlau, Rodryg	Poland	Poznan	Poznan
217	Wojewodzki Szpital Zespolony W Elblagu	Ryniewicz- Zander, Iwona	Poland	Elblag	Elblag
218	Regionalny Szpital Specjalistyczny W Grudziadzu	Sadowska, Uszula	Poland	Grudziadz	Grudziadz
219	Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu	Sawrycki, Piotr	Poland	Torun	Torun
220	Specjalistyczny Szpital Im. Prof. Alfreda Sokolowskiego	Sawrycki, Piotr Serwatowski, Piotr	Poland	Szczecin	Szczecin
221	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy	Szczesna, Aleksandra	Poland	Otwock	Otwock
222	Inst Portugues De Oncologia De Lisboa Francisco Gentil,E.P.E	Almodovar, Teresa	Portugal	LISBOA	Lisboa
223	Centro Hospitalar De Entre O Douro E Vouga, Epe	Araujo, Antonio	Portugal	SANTA MARIA DA FEIRA	Santa Maria Da Feira
224	Centro Hospitalar De Coimbra	Barata, Fernando	Portugal	Coimbra	Coimbra
225	Centro Hospitalar De Vila Nova De Gaia/Espinho, Epe	Parente, Barbara	Portugal	Vila Nova De Gaia	Vila Nova De Gaia
226	Inst Portugues De Oncologia Do Porto Francisco Gentil, E.P.E	Soares, Marta	Portugal	PORTO	Porto
227	Centro Hospitalar Lisboa Norte, Epe - Hospital De Santa Mari	Teixeira, Maria Encarnacao	Portugal	LISBOA	Lisboa
228	Coltea Clinical Hospital	Aldea, Ciprian	Romania	Bucharest	Bucharest
229	Spitalul Judetean De Urgenta	Ganea, Doina Elena	Romania	Suceava	Suceava
230	Ianuli Med Consult Srl	Ianuli, Carmen-Hariclea G	Romania	Bucuresti	Bucuresti
231	Oncomed	Oprean, Cristina Marinela	Romania	Timisoara, Timis	Timisoara, Timis
232	Spitalul Judetean De Urgenta Sibiu	Patran, Monica	Romania	Sibiu	Sibiu
233	Sc Medisprof Srl	Udrea, Anghel Adrian	Romania	Cluj Napoca	Cluj Napoca
234	Johns Hopkins International Medical Centre	Chang, Alex Yuang-Chi	Singapore	Singapore	Singapore
235	Oncocare Cancer Centre	Leong, Swan	Singapore	Singapore	Singapore
236	Sahlgrenska Ostra Hospital	Bergman, Bengt	Sweden	Gothenburg	Gothenburg
237	Department Of Oncology	Johansson, Mikael	Sweden	Umea	Umea
238	Skanes University Hospital	Ohman, Ronny	Sweden	Lund	Lund
239	Dept Of Oncology	Tell, Roger	Sweden	Stockholm	Stockholm
240	Guz Republic Clinical Oncology Dispensary By Moh In Tatarst	Akhmetzyanov, Foat	Russian Federation	Kazan	Kazan
241	Guz Clinical Oncology Dispensary #1	Davidenko, Irina	Russian Federation	Krasnodar	Krasnodar
242	State Institution Of Healthcare	Divnogortseva, Leniza	Russian Federation	Tula	Tula
243	Russian Scientific Center Of Rentgenoradiology	Dobrovolskaya, Natalia	Russian Federation	Moscow	Moscow
244	Chelyabinsk Regional Oncology Dispensary	Gladkov, Oleg	Russian Federation	Chelyabinsk	Chelyabinsk
245	Russian Oncology Research Center Named After Blokhin N.N.	Gorbunova, Vera	Russian Federation	Moscow	Moscow
246	City Clinical Oncology Dispensary	Karaseva, Nina	Russian Federation	St-Peterburg	St-Peterburg
247	Samara Regional Oncology Dispensary	Kopp, Mikhail	Russian Federation	Samara	Samara
248	Russian Oncological Research Center N.A. N.N. Blokhin Rams	Lichinitser, Mikhail	Russian Federation	Moscow	Moscow
249	Saint Petersburg State Medical University	Mosin, Igor	Russian Federation	St. Petersburg	St. Petersburg
250	Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarsta	Mukhametshina, Guzel	Russian Federation	Kazan	Kazan
251	NII Oncology n.a. N.N. Petrov	Protsenko, Svetlana	Russian Federation	Saint Petersburg	Saint Petersburg
252	FGBU Med. Radiol. Research Centre of Rus. Ministry of Health	Ragulin, Yury	Russian Federation	Obninsk	Obninsk
253	Fgu Hospital With Polyclinic	Severtsev, Alexey	Russian Federation	Moscow	Moscow
254	State Healthcare Inst. Pyatigorsk Oncology Dispensary	Vladimirov, Vladimir	Russian Federation	Pyatigorsk	Pyatigorsk
255	Department Of Radiation Oncology	Dalvie, Sameera	South Africa	WESTERN CAPE	Observatory
256	GVI Oncology Clinical Trials Unit	Jacobs, Conrad	South Africa	WESTERN CAPE	Panorama,cape Town
257	G V I Oncology, Rondebosch Oncology Centre	Harris, Jill	South Africa	WESTERN CAPE	Rondebosch
258	Hopelands Cancer Centre	Mall, Riaz	South Africa	KWA ZULU NATAL	Durban
259	Vaal Triangle Oncology-Alberts, Bouwer & Jordaan Inc.	Rens, Daniel	South Africa	EASTERN CAPE	Vereeniging
260	Centre Pluridisciplinaire D'Oncologie Centre Hosp Univ	Peters, Solange	Switzerland	Lausanne	Lausanne
261	Kantonsspital Winterthur	Pless, Miklos	Switzerland	Winterthur	Winterthur
262	Onkologiezentrum Thun-Berner Oberland Spital Sts Ag	Rauch, Daniel	Switzerland	Thun	Thun
263	University Hospital Basel	Zippelius, Alfred	Switzerland	Basel	Basel
264	Hospital Nuestra Senora. De Sonsoles	Ales Martinez, Jose Enrique	Spain	Avila	Avila
265	Hospital General Univ De Valencia	Camps Herrero, Carlos	Spain	Valencia	Valencia
266	Althaia Xarxa Assistencial De Manresa	Catot Tort, Silvia	Spain	Manresa	Manresa
267	Hospital Clinical Benidorm	Esquerdo Galiana, Gaspar	Spain	Benidorm-alicante	Benidorm-alicante
268	Hospital Santa Maria Nai	Firvida Perez, Jose	Spain	Ourense	Ourense
269	Hospital Arnau De Vilanova	Garcia-Sanchez, Jose	Spain	Valencia	Valencia
270	Hospital 12 De Octubre	Iglesias Docampo, Lara Carmen	Spain	Madrid	Madrid
271	Hospital De Mataro	Lianes, Pilar	Spain	Barcelona	Barcelona
272	Hospital De Cruces	Lopez-Vivanco, Guillermo	Spain	Vizcaya	Vizcaya
273	Hospital Provincial De Castellon	Sanchez Hernandez, Alfredo	Spain	Castellon	Castellon
274	Hospital Md Anderson	Sanchez Torres, Jose Miguel	Spain	Madrid	Madrid
275	Taichung Veterans General Hospital	Chang, Gee-Chen	中国	台湾	Taichung
276	China Medical University Hospital	Hsia, Te-Chun	中国	台湾	Taichung City
277	Chang Gung Medical Foundation, Linkou Branch	Kuo, Han-Pin	中国	台湾	Taoyuan
278	Changhua Christian Hospital	Li, Chien-Te	中国	台湾	Changhua
279	Chang Gung Medical Foundation-Chiayi Branch	Lu, Chang-Hsien	中国	台湾	Chiayi
280	Taipei Veterans General Hospital	Tsai, Chun-Ming	中国	台湾	Taipei
281	Chang Gung Medical Foundation-Kaohsiung Branch	Wang, Chin-Chou	中国	台湾	Kaohsiung
282	National Taiwan University Hospital	Yu, Chong-Jen	中国	台湾	Taipei
283	National Cancer Institute, Medical Oncology Unit	Arpornwirat, Wichit	Thailand	Bangkok	Bangkok
284	Holistic Center For Cancer Study And Care (Hocc-Psu)	Dechaphunkul, Arunee	Thailand	Songkla	Songkla
285	Phramongkutklao Hospital	Seetalarom, Kasan	Thailand	Bangkok	Bangkok
286	Division Of Medical Oncology Unit, Department Of Medicine	Srimuninnimit, Vichien	Thailand	Bangkok	Bangkok
287	Faculty Of Medicine, Chulalongkorn University	Sriuranpong, Virote	Thailand	Bangkok	Bangkok
288	Div. Of Medical Oncology, Dept. Of Medicine, Faculty Of Med	Thongprasert, Sumitra	Thailand	Chiang Mai	Chiang Mai
289	Royal Surrey County Hospital	Middleton, Gary	United Kingdom	Surrey	Guildford
290	Southampton University Hospital Nhs Trust	Ottensmeier, Christian	United Kingdom	Hampshire	Southampton
291	The Royal Marsden Hospital	Popat, Sanjay	United Kingdom	Greater London	London
292	Nottingham University Hospitals Nhs Trust	Potter, Vanessa	United Kingdom	Nottinghamshire	Nottingham
293	Ninewells Hospital And Medical School	Rankin, Elaine Mary	United Kingdom	Angus/forfarshire	Dundee
294	Royal Cornwall Hospital	Talbot, Toby	United Kingdom	Cornwall	Truro
295	Weston Park Hospital	Woll, Penella Jane	United Kingdom	Sheffield	Sheffield
296	Sharp Memorial Hospital	Bodkin, David	USA	CA	San Diego
297	Hematology & Med Oncology Of Southern Palm Beach County, Inc	Brito, Rogelio (Roger) A	USA	FL	Boynton Beach
298	Va Connecticut Healthcare System	Chao, Herta	USA	FL	Newington
299	Floyd Memorial Cancer Center Of Indiana	Chowhan, Naveed	USA	CT	New Albany
300	Lynn Cancer Institute Center For Hematology-Oncology	DeCesare, Teresa	USA	IN	Boca Raton
301	Integrated Community Oncology Network	Dees, Iii, Morris	USA	FL	Jacksonville
302	Indiana University Cancer Center	Einhorn, Lawrence	USA	FL	Indianapolis
303	Quincy Medical Group	El-Khoury, Christian	USA	IL	Quincy
304	University Of Illinois At Chicago Medical Center	Feldman, Lawrence	USA	IL	Chicago
305	Southern Illinois University School Of Medicine	Khan, Aziz-Ur-Rehman	USA	IL	Springfield
306	Orchard Healthcare Research Inc.	Oliff, Ira Anton	USA	IL	Skokie
307	St. Francis Hospital & Health Centers	Slaughter, Michael	USA	IN	Beech Grove
308	Clinical Research Alliance, Inc.	Arena, Francis P	USA	NY	Lake Success
309	Syracuse Va Medical Center	Gajra, Ajeet	USA	NY	Syracuse
310	Kentucky Cancer Clinic	Ghazal, Hassan H	USA	KY	Hazard
311	Norton Cancer Institute	Harandi, Amir	USA	KY	Louisville
312	Durham Va Medical Center	Kelley, Michael	USA	NC	Durham
313	Piedmont Hematology Oncology Associates, Pllc	Paschold, Eugene H	USA	NC	Winston Salem
314	Duke University Medical Center	Potti, Anil	USA	NC	Butner
315	Carolina Biooncology Institute	Powderly Ii,, John D	USA	NC	Huntersville
316	Presbyterian Hospital Cancer Research	Reiling, Richard	USA	NC	Charlotte
317	Montgomery Cancer Center	Zaydan, Muhammad-Ali	USA	KY	Mount Sterling
318	Washington University School Of Medicine	Baggstrom, Maria	USA	MO	Saint Louis
319	Oklahoma Oncology And Hematology, Pc Dba	Buck, Steven C	USA	OK	Tulsa
320	Singing River Health System	Clarkson, James	USA	MS	Pascagoula
321	University Of Minnesota	Dudek, Arkadiusz Z	USA	MN	Minneapolis
322	Gabrail Cancer Center Research	Gabrail, Nashat Y	USA	OH	Dover
323	Warren Cancer Research Foundation	Lynch, Joseph	USA	OK	Tulsa
324	Kansas City Cancer Centers -South	Pendergrass, Kelly	USA	MO	Kansas City
325	Dartmouth-Hitchcock Medical Center	Rigas, James	USA	NH	Lebanon
326	St Joseph Mercy Hospital	Stella, Philip	USA	MI	Ann Arbor
327	Tennessee Cancer Specialists	Dobbs, Tracy W	USA	TN	Knoxville
328	Associated in Oncology and Hematology	Gandhi, Jitendra	USA	TN	Chattanooga
329	Cancer Center Of The Carolinas	Gluck, William	USA	SC	Easley
330	Cancer Center At Cookeville Regional Medical Center	Jacquin, Paul N	USA	TN	Cookeville
331	Thompson Oncology Group	Mccachren Jr., Samuel S	USA	TN	Knoxville
332	Providence Regional Med Cntr Everett/Cancer Partnership	Saikaly, Elie	USA	WA	Everett
333	Texas Oncology, PA - South Austin Cancer Center	Uyeki, James	USA	TX	Austin
334	Wjb Dorn Va Medical Center	Wallam, Mohammed	USA	SC	Columbia
335	Blue Ridge Cancer Care	Goldschmidt, Jr., Jerome H	USA	VA	Salem
336	Guthrie Clinic, Ltd	Lash, Bradley	USA	PA	Sayre
337	Wisconsin Institutes for Medical Research	Leal, Ticiana	USA	WI	Madison
338	Kaiser Permanente Northwest Region	Rarick, Mark Urban	USA	OR	Portland
339	Cancer Outreach Associates, Pc	Swan, Jr., Forrest	USA	VA	Abingdon

序号	名称	审查结论	批准日期/备案日期
1	中山大学肿瘤防治中心伦理委员会	同意	2013-07-07
2	中山大学肿瘤防治中心伦理委员会	同意	2014-08-15

已完成

目标入组人数	国内: 80 ； 国际: 920 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 48  ； 国际: 923 ；

第一例受试者签署知情同意书日期	国内：2013-09-03；     国际：2011-08-22；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：2015-12-14；     国际：2016-12-09；