广州ipilimumab注射液(BMS)III期临床试验-ipilimumab与化疗联合和单纯化疗治疗SCLC患者的疗效比较

登记号	CTR20130574	试验状态	已完成
申请人联系人	王亦男	首次公示信息日期	2014-03-13
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	CTR20130574
相关登记号	暂无
药物名称	ipilimumab 注射液(BMS)
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	小细胞肺癌
试验专业题目	比较ipilimumab加依托泊苷/铂类与依托泊苷/铂类治疗新诊断的ED-SCLC患者疗效的随机、多中心、双盲、3期试验
试验通俗题目	ipilimumab与化疗联合和单纯化疗治疗SCLC患者的疗效比较
试验方案编号	CA184-156	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	王亦男	联系人座机	021-23218341	联系人手机号	暂无
联系人Email	nancy.wang@bms.com	联系人邮政地址	上海南京西路1717号会德丰国际广场59楼	联系人邮编	200040

比较新诊断的广泛期SCLC受试者中被随机分组为接受ipilimumab联合铂类和依托泊苷的受试者（A组）与被随机分组为接受安慰剂联合铂类及依托泊苷的受试者（B组）的总体生存期(OS)。

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 广泛期小细胞肺癌患者 2 ECOG评分0-1分 3 广泛期小细胞肺癌患者 4 ECOG评分0-1分
排除标准	1 已接受过针对肺癌的系统性治疗 2 已接受过针对肺癌的系统性治疗 3 存在中枢神经系统转移症状 4 有自身免疫性疾病史 5 有自身免疫性疾病史 6 存在中枢神经系统转移症状

试验药

序号 名称 用法 1 中文通用名:ipilimumab注射液(BMS) 用法用量: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。 2 中文通用名:ipilimumab注射液(BMS) 用法用量: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（研究中心自备） 用法用量:注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC5，每3周第1天给药一次，连续使用4个周期 4 中文通用名:依托泊苷（研究中心自备） 用法用量:注射液；规格：100mg/5mL/瓶；静脉注射（IV）；用量：100mg/m2，在每个周期的第1、2、3天分别给药一次，连续使用4个周期 5 中文通用名:顺铂（研究中心自备） 用法用量:注射液；规格：100mg/100mL/瓶；静脉注射（IV）；用量：75mg/m2，每3周第1天给药一次，连续使用4个周期 6 中文通用名:顺铂（研究中心自备） 用法用量:注射液；规格：100mg/100mL/瓶；静脉注射（IV）；用量：75mg/m2，每3周第1天给药一次，连续使用4个周期 7 中文通用名:卡铂（研究中心自备） 用法用量:注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC5，每3周第1天给药一次，连续使用4个周期 8 中文通用名:依托泊苷（研究中心自备） 用法用量:注射液；规格：100mg/5mL/瓶；静脉注射（IV）；用量：100mg/m2，在每个周期的第1、2、3天分别给药一次，连续使用4个周期

对照药

序号 名称 用法 1 中文通用名:顺铂（研究中心自备） 用法用量:注射液；规格：100mg/100mL/瓶；静脉注射（IV）；用量：75mg/m2，每3周第1天给药一次，连续使用4个周期 2 中文通用名:顺铂（研究中心自备） 用法用量:注射液；规格：100mg/100mL/瓶；静脉注射（IV）；用量：75mg/m2，每3周第1天给药一次，连续使用4个周期 3 中文通用名:卡铂（研究中心自备） 用法用量:注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC5，每3周第1天给药一次，连续使用4个周期 4 中文通用名:依托泊苷（研究中心自备） 用法用量:注射液；规格：100mg/5mL/瓶；静脉注射（IV）；用量：100mg/m2，在每个周期的第1、2、3天分别给药一次，连续使用4个周期 5 中文通用名:安慰剂注射液（研究中心自备） 用法用量:0.9%生理盐水/5%葡萄糖注射液；静脉注射（IV）；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。 6 中文通用名:安慰剂注射液（研究中心自备） 用法用量:0.9%生理盐水/5%葡萄糖注射液；静脉注射（IV）；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。 7 中文通用名:依托泊苷（研究中心自备） 用法用量:注射液；规格：100mg/5mL/瓶；静脉注射（IV）；用量：100mg/m2，在每个周期的第1、2、3天分别给药一次，连续使用4个周期 8 中文通用名:卡铂（研究中心自备） 用法用量:注射液；规格：450mg/瓶；静脉注射（IV）；用量：AUC5，每3周第1天给药一次，连续使用4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 观察到816例受试者死亡后进行评价，在612例受试者死亡后进行中期分析 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 比较A组与B组间接受盲态研究治疗的受试者的OS 观察到816例受试者死亡后进行评价 有效性指标 2 比较A组与B组间的免疫相关无进展生存期(irPFS) 观察到816例受试者死亡后进行评价 有效性指标 3 估计每组治疗组中根据mWHO的缓解持续时间(DoR) 观察到816例受试者死亡后进行评价 有效性指标 4 估计每组治疗组根据mWHO的最佳总体缓解率(BORR) 观察到816例受试者死亡后进行评价 有效性指标 5 比较A组与B组间的无进展生存期(mWHO) 观察到816例受试者死亡后进行评价 有效性指标

1	姓名	吴一龙	学位	暂无	职称	主任
	电话	020-83827812-21187	Email	syylwu@live.cn	邮政地址	广州市中山东路106号
	邮编	510080	单位名称	广东省人民医院

序号	机构名称	主要研究者	国家	省（州）	城市
1	广东省人民医院	吴一龙	中国	广东	广州
2	中国医科大学附属第一医院	刘云鹏	中国	辽宁	沈阳
3	中山大学肿瘤防治中心	张力	中国	广东	广州
4	北京协和医院	王孟昭	中国	北京	北京
5	中国人民解放军第三〇七医院	刘晓晴	中国	北京	北京
6	中国医学科学院肿瘤医院	石远凯	中国	北京	北京
7	北京大学肿瘤医院	王洁	中国	北京	北京
8	西安交通大学医学院第一附属医院	南克俊	中国	陕西	西安
9	上海市肺科医院	周采存	中国	上海	上海
10	上海市胸科医院	韩宝惠	中国	上海	上海
11	浙江大学医学院附属邵逸夫医院	潘宏铭	中国	浙江	杭州
12	中国人民解放军第八一医院	秦叔逵	中国	江苏	南京
13	四川大学华西医院	侯梅	中国	四川	成都
14	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
15	新疆医科大学附属肿瘤医院	刘春玲	中国	新疆	乌鲁木齐
16	中国人民解放军总医院	焦顺昌	中国	北京	北京
17	苏州大学附属第一医院	陶敏	中国	江苏	苏州
18	浙江大学医学院附属第二医院	黄建瑾	中国	浙江	杭州
19	华中科技大学同济医学院附属协和医院	刘莉	中国	湖北	武汉
20	天津肿瘤医院	李凯	中国	天津	天津
21	吉林省肿瘤医院	程颖	中国	吉林	长春
22	哈尔滨医科大学附属肿瘤医院	陈公言	中国	黑龙江	哈尔滨
23	Sanatorio Parque	Brown Arnold, Mario	Argentina	SANTA FE	Rosario
24	Hospital Britanico De Buenos Aires	Korbenfeld, Ernesto	Argentina	BUENOS AIRES	Buenos Aires
25	Clinica Universitaria Privada Reina Fabiola	Lingua, Alejo	Argentina	CORDOBA	Ciudad De Cordoba
26	Cer Instituto Medico	Varela, Mirta Susana	Argentina	BUENOS AIRES	Quilmes
27	Consultorios Medicos Privados S. A.	Wainstein, Sebastian	Argentina	BUENOS AIRES	Ramos Mejia.La Matanza
28	Southern Medical Day Care Centre	Clingan, Philip	Australia	New South Wales	Wollongong
29	Sir Charles Gairdner Hospital	Hasani, Arman	Australia	Wa	Nedlands
30	The Prince Charles Hospital/Oncology Internal Med Service	Hughes, Brett Gordon Maxwell	Australia	Queensland	Chermside
31	The Townsville Hospital	Joshi, Abhishek	Australia	Queensland	Douglas
32	Flinders Medical Centre	Karapetis, Christos Stelios	Australia	South Australia	Bedford Park
33	St. George Hospital	Lee, Chee	Australia	New South Wales	Kogarah
34	Box Hill Hospital	Parente, Phillip	Australia	Victoria	Box Hill
35	Border Medical Oncology	Underhill, Craig Richard	Australia	Victoria	Wodonga
36	Krankenhaus Der Elisabethinen Linz GmbH	Bolitschek, Josef	Austria	Linz	Linz
37	Klinikum Wels-Grieskirchen Gmbh	Kolb, Rainer	Austria	Wels	Wels
38	Akh Wien	Pirker, Robert	Austria	Wien	Wien
39	Landeskliniken Salzburg, St. Johanns-Spital	Studnicka, Michael	Austria	Salzburg	Salzburg
40	Khr Hietzing	Ulsperger, Ernst	Austria	Wien	Wien
41	Smz Baumgartner Hoehe - Otto Wagner Spital	Vetter, Norbert	Austria	Wien	Wien
42	Chu De Liege	Bosquee, Leon	Belgium	Liege	Liege
43	Uz Antwerpen	Janssens, Annelies	Belgium	Edegem	Edegem
44	Universitair Ziekenhuis Leuven	Nackaerts, Kristiaan	Belgium	Leuven	Leuven
45	Chu Mont-Godinne	Ocak, Sebahat	Belgium	Yvoir	Yvoir
46	Universitair Ziekenhuis Brussel	Schallier, Denis	Belgium	Brussel	Brussel
47	Hospital Erasto Gaertner- CEPEP/Pesquisa	De Oliveira, Fabricio Augusto	Brazil	Parana	Curibita
48	Instituto De Oncologia Do Vale	Fernandes, Henrique Zanoni	Brazil	Sao Paulo	Sao Jose dos Campos
49	Hospital Da Cidade	Lazaretti, Nicolas	Brazil	Rio Grande do Sul	Passo Fundo
50	Santa Casa De Porto Alegre	Pereira, Rodrigo	Brazil	Rio Grande do Sul	Porto Alegre-rs
51	Instituto Do Cancer Do Estado De Sao Paulo - Icesp	Roitberg, Felipe Santa Rosa	Brazil	Sao Paulo	Sao Paulo
52	Cepeville	Santin, Andrea	Brazil	Santa Catarina	Joinville
53	Clinionco	Zadra, Cyntia	Brazil	Rio Grande do Sul	Porto Alegre
54	Hopital Du Sacre-Coeur De Montreal	Diaconescu, Razvan	Canada	Qc	Montreal
55	Mcgill University	Owen, Scott	Canada	Qc	Montreal
56	Princess Margaret Hospital	Shepherd, Frances A	Canada	On	Toronto
57	Chum-Hopital Notre-Dame	Tehfe, Mustapha	Canada	Quebec	Montreal
58	London Regional Cancer Centre	Vincent, Mark D	Canada	On	Toronto
59	Hospital Carlos Van Buren	Acevedo Gaete, Alejandro Andres	Chile	Valparaiso	Valparaiso
60	Centro Internacional de Estudios Clinicos	Aren Frontera, Osvaldo	Chile	Region Metropolitana	Santiago
61	Hospital San Borja Arriaran	Campos Munoz, Monica	Chile	Santiago	Santiago
62	Centro Nacional De Investigaciones Clinicas (Cenic)	Reyes Vidal, Jose Miguel	Chile	METROPOLITANA	METROPOLITANA
63	Instituto Oncologico Clinica Renaca	Gonzalez Mella, Pablo	Chile	VALPARAISO	Vina Del Mar
64	Instituto Oncologico	Gonzalez Mella, Pablo	Chile	VALPARAISO	Vina Del Mar
65	Centro Investigaciones Clinicas	Gonzalez Mella, Pablo	Chile	Santiago	Metropolitana
66	Oncomedica S. A.	Gonzalez, Manuel	Colombia	CORDOBA	Monteria
67	Ciosad- Clinica San Diego	Ramirez Pinto, Guillermo	Colombia	CUNDINAMARCA	Bogota
68	Oncologos De Occidente S.A	Rojas, Gustavo Adolfo	Colombia	RISARALDA	Pereira
69	Fn Na Bulovce	Havel, Libor	Czech Republic	Prague 8	Prague 8
70	Fn Ostrava - Poruba	Roubec, Jaromir	Czech Republic	Ostrava	Ostrava
71	VFN Prague	Zemanova, Milada	Czech Republic	Prague	Prague
72	Helsinki And Uusimaa Hospital District, Jorvi Hospital	Lojander, Jukka	Finland	Espoo	Espoo
73	Helsinki And Uusimaa Hosp Dist, Helsinki Univ Central Hosp	Riska, Henrik	Finland	Helsinki	Helsinki
74	Turku University Hospital	Saariaho, Taneli	Finland	Turku	Turku
75	Hopital De Brabois	Clement-Duchene, Christelle	France	Vandoeuvre-les-nancy	Hopital De Brabois
76	Chu De Rennes, Hopital Pontchaillou	Corre, Romain	France	Rennes Cedex 9	Chu De Rennes, Hopital Pontchaillou
77	Centre Francois Baclesse	Gervais, Radj	France	Caen	Centre Francois Baclesse
78	Hopital Lyautey	Quoix, Anne-Elizabeth	France	Strasbourg Cedex	Hopital Lyautey
79	Klinik Fur Hamatologie Und Internistische Onkologie	Behringer, Dirk	Germany	Bochum	Bochum
80	Universitatsklinikum Hamburg-Eppendorf	Berger, Lars Arne	Germany	Hamburg	Hamburg
81	Universitatsklinikum Frankfurt	Brandts, Christian	Germany	Frankfurt	Frankfurt
82	Stadt. Klinikum Munchen GmbH	Feurer, Matthias	Germany	Munchen	Munchen
83	Universitatsklinikum Erlangen	Fuchs, Florian	Germany	Erlangen	Erlangen
84	Klinik Fur Haematologie Und Onkologie	Griesinger, Frank	Germany	Oldenburg	Oldenburg
85	Zentrum Fur Pneumologie Und Thoraxchirurgie	Reck, Martin	Germany	Grosshansdorf	Grosshansdorf
86	Chirurgische Klinik/Interdisziplinaere Thorakale Onkologie	Schmid-Bindert, Gerald	Germany	Mannheim	Mannheim
87	Zentralklinik Bad Berka Gmbh	Schneider, Claus-Peter	Germany	Bad Berka	Bad Berka
88	Universitatsklinikum Ulm	Schumann, Christian	Germany	Ulm	Ulm
89	Universitaetsklinikum Carl Gustav Carus	Stohlmacher-Williams, Jan	Germany	Dresden	Dresden
90	Thoraxklinik-Heidelberg Ggmbh	Thomas, Michael	Germany	Heidelberg	Heidelberg
91	Asklepius Fachkliniken	Von Pawel, Joachim	Germany	Gauting	Gauting
92	Iii Med Kinik Und Poliklinik	Wehler, Thomas	Germany	Mainz	Mainz
93	Medizinische Klinik Iv	Wolf, Martin	Germany	Kassel	Kassel
94	Queen Elizabeth Hospital	Au, Siu Kie	中国	Hong Kong	Hong Kong
95	Queen Mary Hospital	Lee, Ho Fun Victor	中国	Hong Kong	Hong Kong
96	Tuen Mun Hospital	Lo, Sing Hung	中国	Hong Kong	Hong Kong
97	Matrai Gyogyintezet	Albert, Istvan	Hungary	Matrahaza	Matrahaza
98	Soproni Erzsebet Oktato Korhaz	Bartfai, Zoltan	Hungary	Sopron	Sopron
99	Orszagos Koranyi Tbc Es Pulmonologiai Intezet	Bogos, Krisztina	Hungary	Budapest	Budapest
100	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointez	Csoszi, Tibor	Hungary	Szolnok	Szolnok
101	Semmelweis Egyetem, Pulmonologiai Klinika	Losonczy, Gyorgy	Hungary	Budapest	Budapest
102	Orszagos Koranyi Tbc Es Pulmonologiai Intezet	Ostoros, Gyula	Hungary	Budapest	Budapest
103	Fejer Megyei Szent Gyorgy Korhaz	Papai-Szekely, Zsolt	Hungary	Szekesfehervar	Szekesfehervar
104	Pte Klinikai Kozpont 1.Sz. Belgyogyaszati Klinika, Pulmonolo	Sarosi, Veronika	Hungary	Pecs	Pecs
105	Midwestern Cancer Center	Coate, Linda	Ireland	Limerick	Limerick
106	St Vincent's University Hospital	Hanrahan, Emer	Ireland	Dublin	Dublin
107	St. James'S Hospital	O Byrne, Ken	Ireland	Dublin	Dublin
108	Adelaide Meath National Childrens Hospital	Rozana Walshe, Janice	Ireland	Dublin	Dublin
109	The Soroka University Medical Center	Ariad, Samuel	Israel	Beer Sheva	Beer Sheva
110	Oncology Institute, Sheba Medical Center	Biran, Haim	Israel	Ramat -gan	Ramat -gan
111	Oncology Institute, Assaf Harofeh Medical Center	Cyjon, Arnold	Israel	Zerifin	Zerifin
112	Meir Medical Center	Gottfried, Maya	Israel	Kfar-saba	Kfar-saba
113	Insitute Of Oncology, Rabin Medical Center	Stemmer, Salomon	Israel	Petah-tikva	Petah-tikva
114	Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori	Amadori, Dino	Italy	Meldola (FC)	Meldola (FC)
115	Ospedale Campo Di Marte	Baldini, Editta	Italy	Lucca	Lucca
116	Ospedale Civile Di Livorno	Cappuzzo, Federico	Italy	Livorno	Livorno
117	Azienda Ospedaliera Di Perugia	Crino, Lucio	Italy	Perugia	Perugia
118	Aichi Cancer Center Central Hospital	Hida, Toyoaki	Japan	Aichi	Nagoya
119	National Hospital Organization Nagoya Medical Center	Saka, Hideo	Japan	Aichi	Nagoya-shi
120	National Nagoya Hospital	Saka, Hideo	Japan	Aichi	Nagoya-shi
121	National Cancer Center Hospital East	Ohmatsu, Hironobu	Japan	Chiba	Kashiwa
122	Kyushu University Hospital	Takayama, Koichi	Japan	FUKUOKA	Fukuoka-shi
123	National Hospital Organization Kyushu Cancer Center	Takenoyama, Mitsuhiro	Japan	FUKUOKA	Fukuoka-shi
124	Hokkaido University Hospital	Kinoshita, Ichiro	Japan	Hokkaido	Sapporo
125	Kanazawa University Hospital	Kasahara, Kazuo	Japan	ISHIKAWA	Kanazawa-shi
126	Kanagawa Cardiovascular and Respiratory Center	Kato, Terufumi	Japan	Kanagawa	Yokohama-Shi
127	Yokohama Municipal Citizen's Hospital/Respiratory Internal Medicine	Okamoto, Hiroaki	Japan	Kanagawa	Yokohama-Shi
128	Miyagi Cancer Center	Fukuhara, Tatsuro	Japan	Miyagi	Natori-shi
129	Tohoku University Hospital	Sakakibara, Tomohiro	Japan	Miyagi	Sendai
130	Kawasaki Medical School Hospital	Oka, Mikio	Japan	Okayama	Kurashiki-shi
131	Kurashiki Central Hospital	Yoshioka, Hiroshige	Japan	Okayama	Kurashiki-shi
132	Osaka Medical College Hospital	Fujisaka, Yasuhito	Japan	Osaka	Takatsuki
133	Kansai Medical University Hirakata Hospital	Kurata, Takayasu	Japan	Osaka	Hirakata-shi
134	Shizuoka Cancer Center	Naito, Tateaki	Japan	Shizuoka	Sunto-gun
135	Cancer Institute Hospital Of Jfcr	Nishio, Makoto	Japan	Tokyo	Koto-ku
136	National Cancer Center Hospital	Yamamoto, Noboru	Japan	Tokyo	Chuo-ku
137	Yamaguchi Ube Medical Center	Chikamori, Kenichi	Japan	Yamaguchi	Ube-shi
138	Hokkaido Cancer Center	Harada, Masao	Japan	Hokkaido	Sapporo
139	Shikoku Cancer Center	Kozuki, Toshiyuki	Japan	Ehime	Matsuyama
140	Kinki University Hospital, Faculty of Medicine	Nakagawa, Kazuhiko	Japan	Osaka	Osaka
141	Hyogo Cancer Center	Satouchi, Miyako	Japan	Hyogo	Akashi
142	Sendai Kosei Hospital	Sugawara, Shunichi	Japan	Miyagi	Sendai
143	Osaka City General Hospital	Takeda, Koji	Japan	Osaka	Osaka
144	Instituto Nacional De Cancerologia	Arrieta, Oscar	Mexico	Distrito Federal	Mexico City
145	Fundacion Rodolfo Padilla Padilla A.C.	Gonzalez Trujillo, Jose Luis	Mexico	Guanajuato	Leon de los Aldama
146	Centro Regional de Enfermedades Oncologicas	Guel Panola, Jaime Arturo	Mexico	San Luis Potosi	San Luis Potosi
147	Centro Estatal De Cancerologia Dr Miguel Dorantes Mesa	Pardo, Rafael	Mexico	Veracruz	Xalapa
148	Antiguo Hospital Civil Fray Antonio Alcalde	Ramirez Godinez, Francisco	Mexico	Jalisco	Guadalajara
149	Hospital De Oncologia Del Centro Medico Siglo Xxi Imss	Villalobos-Valencia, Ricardo	Mexico	Distrito Federal	Mexico
150	Amphia Ziekenhuis ( Amphia Hospital)	Aerts, Joachim	Netherlands	Breda	Breda
151	Jeroen Bosch Ziekenhuis (Jeroen Bosch Hospital)	Biesma, Bonne	Netherlands	's-Hertogenbosch	's-Hertogenbosch
152	Hospital Universitari Arnau De Vilanova	Herder, Judith G.J.M	Netherlands	Lleida	Lleida
153	Catharina Ziekenhuis	Van Den Borne, B.E.E.M	Netherlands	Eindhoven	Eindhoven
154	Oncosalud Sac	Aguilar Cartagena, Alfredo	Peru	LIMA	Lima
155	Hospital Nacional Dos De Mayo	Chumbes, Mirna	Peru	LIMA	Lima
156	Instituto De Oncolog Y Radiot De La Clinica Ricardo Palma	Rodriguez, Wuilbert	Peru	LIMA	Lima
157	Clinica Peruano Americana / Centro De Invest. Clin Trujillo	Zorrilla Silvera, Jose David	Peru	LA LIBERTAD	Trujillo
158	Uniwersytet Medyczny Im. Karola Marcinkowskiego	Batura-Gabryel, Halina	Poland	Poznan	Poznan
159	Krakowski Szpital Specjalistyczny Im.Jana Pawla Ii	Czyzewicz, Grzegorz	Poland	Krakow	Krakow
160	Centrum Onkologii - Instytut Im. Marii Sklodowskiej Curie	Kowalski, Dariusz	Poland	Warszawa	Warszawa
161	Oddzial Onkologii I Radioterapii Szpital Morski Im. Pck	Lesniewski-Kmak, Krzysztof	Poland	Gdynia	Gdynia
162	SPSK nr 7 SUM w Katowicach	MROCHEN-DOMIN, IZOLDA	Poland	Katowice - Ochojec	Katowice - Ochojec
163	Wojewodzkie Centrum Onkologii Sp Zoz	Pikiel, Joanna	Poland	Gdansk	Gdansk
164	Szpital Im. St. Leszczynskiego	Poborski, Wojciech	Poland	Katowice	Katowice
165	Wojewodzki Szpital Zespolony W Elblagu	Ryniewicz-Zander, Iwona	Poland	Elblag	Elblag
166	Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu	Sawrycki, Piotr	Poland	Torun	Torun
167	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy	Szczesna, Aleksandra	Poland	Otwock	Otwock
168	Dolnoslaskie Centrum Chorob Pluc We Wroclawiu	Tomeczko, Janusz	Poland	Wroclaw	Wroclaw
169	Inst Portugues De Oncologia De Lisboa Francisco Gentil,E.P.E	Almodovar, Teresa	Portugal	Lisboa	Lisboa
170	Centro Hospitalar De Coimbra	Barata, Fernando	Portugal	Coimbra	Coimbra
171	Centro Hospitalar De Vila Nova De Gaia/Espinho, Epe	Parente, Barbara	Portugal	Vila Nova De Gaia	Vila Nova De Gaia
172	Pusan National University Hospital	Chung, Joo-Seop	Republic of Korea	Busan	Busan
173	National Cancer Center	Kim, Heung Tae	Republic of Korea	Goyang-si	Gyeonggji-do
174	The Catholic University Of Korea St. Vincent'S Hosp	Kim, Hoon Kyo	Republic of Korea	Suwon	Gyeonggji-do
175	Severance Hospital	Kim, Joo-Hang	Republic of Korea	Seoul	Seoul
176	Asan Medical Center	Kim, Sang-We	Republic of Korea	Seoul	Seoul
177	Chomman National University Hwasun Hospital	Kim, Young-Chul	Republic of Korea	Hwasun	JEONNAM
178	Ajou University Hospital	Lee, Hyun Woo	Republic of Korea	Suwon	Gyeonggji-do
179	Chungbuk National University Hospital	Lee, Ki Hyeong	Republic of Korea	Cheongju-si	Cheongju-si
180	Samsung Medical Center	Park, Keunchil	Republic of Korea	Seoul	Seoul
181	Korea University Anam Hospital	Shin, Sang Won	Republic of Korea	Seoul	Seoul
182	Prof. Dr. Al.Chiricuta Oncologic Institute Cluj Napoca	Cebotaru, Cristina Ligia	Romania	Cluj Napoca	Cluj Napoca
183	S.C. Oncolab SRL	Lungulescu, Dan	Romania	Craiova	Craiova
184	Sc Medisprof Srl	Udrea, Anghel Adrian	Romania	Cluj Napoca	Cluj Napoca
185	Guz Clinical Oncology Dispensary #1	Davidenko, Irina	Russian Federation	Krasnodar	Krasnodar
186	City Clinical Hospital#1	Filippov, Alexander	Russian Federation	Novosibirsk	Novosibirsk
187	Chelyabinsk Regional Oncology Dispensary	Gladkov, Oleg	Russian Federation	Chelyabinsk	Chelyabinsk
188	Russian Oncological Research Center N.A. N.N. Blokhin Rams	Gorbunova, Vera	Russian Federation	Moscow	Moscow
189	St.Petersburg City Clinical Oncology Dispensary	Karaseva, Nina	Russian Federation	St. Petersburg	St. Petersburg
190	Kursk Regional Clinical Oncology Dispensary	Kiselev, Igor	Russian Federation	Kursk	Kursk
191	Russian Oncological Research Center N.A. N.N. Blokhin Rams	Komov, Dmitry	Russian Federation	Moscow	Moscow
192	Leningrad Regional Clinical Hospital	Luft, Alexander	Russian Federation	St. Petersburg	St. Petersburg
193	Scientific Research Institute Of Oncology N.A. N.N. Petrov	Protsenko, Svetlana	Russian Federation	St. Petersburg	St. Petersburg
194	pyatigorsk oncology dispensary	Vladimirov, Vladimir	Russian Federation	Pyatigorsk	Pyatigorsk
195	LE34 Department of Radiation Oncology	Dalvie, Sameera	South Africa	Western Cape	Cape Town
196	Department Of Medical Oncology	Dreosti, Lydia Mary	South Africa	Gauteng	Pretoria
197	G V I Oncology, Langenhoven Drive Oncology Centre	Dupper, Louis	South Africa	EASTERN CAPE	Port Elizabeth
198	Lung Och Allergikliniken	Kolbeck, Karl-Gustav	Sweden	Uppsala	Uppsala
199	Lung Och Allergikliniken	Lamberg, Kristina	Sweden	Uppsala	Uppsala
200	Dept Of Pulmonary Medicine	Vikstrom, Anders	Sweden	Linkoping	Linkoping
201	Hospital Universitari De Girona Dr Josep Trueta	Bosch-Barrera, Joaquin	Spain	Cataluna	Girona
202	Hospital Clinical Benidorm	Esquerdo Galiana, Gaspar	Spain	Benidorm-alicante	Benidorm-alicante
203	Hospital Universitari Vall D'Hebron	Felip, Enriqueta	Spain	Barcelona	Barcelona
204	Complejo Hospitalario Universitario A Coru？a	Garcia Campelo, Rosario	Spain	A Coruna	A Coruna
205	Hospital Carlos Haya De Malaga	Gutierrez Calderon, Vanesa	Spain	Malaga	Malaga
206	Hospital Universitario Dr. Peset	Munoz Langa, Jose	Spain	Valencia	Valencia
207	Hospital Provincial De Castellon	Sanchez Hernandez, Alfredo	Spain	Castellon	Castellon
208	Hospital Universitario Puerta De Hierro	Sanchez, Antonio	Spain	Madrid	Majadahonda
209	Hospital Clinico Universitario Virgen De La Victoria	Trigo, Jose	Spain	Malaga	Malaga
210	Klinik Und Poliklinil Fur Onkologie	Curioni, Alessandra	Switzerland	Zuerich	Zuerich
211	Medizinische Onkologie Und Tumorzentrum	Pless, Miklos	Switzerland	Winterthur	Winterthur
212	Klinik Fur Onkologie	Zippelius, Alfred	Switzerland	Basel	Basel
213	Taichung Veterans General Hospital	Chang, Gee-Chen	中国	台湾	Taichung
214	Hyperbaric MED CNTR China Med. Univ. Hosp.	Hsia, Te-Chun	中国	台湾	Taichung City
215	Changhua Christian Hospital	Li, Chien-Te	中国	台湾	Changhua
216	Chang Gung Medical Foundation-Kaohsiung Branch	Wang, Chin-Chou	中国	台湾	Kaohsiung County
217	Chang Gung Medical Foundation, Linkou Branch	Yang, Cheng-Dar	中国	台湾	Taoyuan County
218	National Taiwan University Hospital	Yang, Chih-Hsin	中国	台湾	Taipei
219	National Cancer Institute, Medical Oncology Unit	Arpornwirat, Wichit	Thailand	Bangkok	Bangkok
220	Division of Medical Oncology unit, Department of Medicine, 13th Fl. Chalerm-Prak	Srimuninnimit, Vichien	Thailand	Bangkok	Bangkok
221	Maharaj Nakorn Chiangmai Hospital, Chiangmai University	Thongprasert, Sumitra	Thailand	Chiang Mai	Chiang Mai
222	Royal Preston Hospital	Appel, Wiebke	United Kingdom	Preston	Preston
223	North Middlesex Hospital	Chao, David	United Kingdom	London	London
224	The Christie NHS Foundation Trust	Lorigan, Paul	United Kingdom	Withington	Manchester
225	The Royal Marsden Hospital	Popat, Sanjay	United Kingdom	London	London
226	Ninewells Hospital	Rankin, Elaine Mary	United Kingdom	Fife	Dundee
227	Royal Cornwall Hospital	Talbot, Toby	United Kingdom	Cornwall	Truro
228	UCSD Moores Cancer Center	Bazhenova, Lyudmila	USA	CA	La Jolla
229	Sutter Medical Center	Behl, Deepti	USA	CA	Roseville
230	Marin Cancer Care, Inc	Eisenberg, Peter D	USA	CA	Greenbrae
231	Providence St. Joseph Medical Center	Rosen, Peter	USA	CA	Burbank
232	Genesis Cancer Center	Webb, Roy	USA	AZ	Hot Springs
233	Cancer Specialists, LLC	Bubis, Jeffrey	USA	FL	Jacksonville
234	University Of Colorado Cancer Center	Doebele, Robert	USA	CO	Aurora
235	Florida Cancer Specialists	Hussein, Maen	USA	FL	St. Petersburg
236	Cancer Care Of North Florida, Pa	Khan, Wasseemullah	USA	FL	Lake City
237	University Of Florida College Of Medicine	Pham, Dat	USA	FL	Jacksonville
238	Sacred Heart Medical Oncology Group	Sunnenberg, Thomas	USA	FL	Pensacola
239	Suburban Hematology - Oncology Association	Hagenstad, Christopher	USA	GA	Lawrenceville
240	Medical Oncology Associates Of Augusta,Pc	Townsend, Donald	USA	GA	Augusta
241	Straub Clinic And Hospital	Okazaki, Ian	USA	HI	Honolulu
242	Quincy Medical Group	El-Khoury, Christian	USA	IL	Quincy
243	Siu School Of Medicine	Khan, Aziz	USA	IL	Springfield
244	Orchard Healthcare Research Inc.	Oliff, Ira Anton	USA	IL	Skokie
245	University Of Chicago Hospitals	Vokes, Everett E.	USA	IL	Chicago
246	University Of Kentucky	Arnold, Susanne	USA	KY	Lexington
247	Floyd Memorial Cancer Center Of Indiana	Chowhan, Naveed	USA	IN	New Albany
248	Cancer Center Of Kansas	Dakhil, Shaker	USA	KS	Parsons
249	Ashland Bellefonte Cancer Center	Jain, Kirti	USA	KY	Ashland
250	St. Francis Medical Group Oncology And Hematology Specialist	Slaughter, Michael	USA	IN	Indianapolis
251	Montgomery Cancer Center	Zaydan, Muhammad-Ali	USA	KY	Mount Sterling
252	Alamance Regional Cancer Center	Choksi, Janak	USA	NC	Burlington
253	Karmanos Cancer Institute	Gadgeel, Shirish	USA	MI	Detroit
254	St. Luke'S Cancer Institute	Gaur, Rakesh	USA	MO	Kansas City
255	Durham Va Medical Center (111g)	Kelley, Michael	USA	NC	Durham
256	Piedmont Hematology Oncology Associates, Pllc	Paschold, Eugene H	USA	NC	Winston Salem
257	Mary Bird Perkins Cancer Center	Schmeeckle, Kellie	USA	LA	Baton Rouge
258	St Joseph Mercy Hospital	Stella, Philip	USA	MI	Ann Arbor
259	Southeast Nebraska Hematology & Oncology Consultants, P.C.	Dunder, Steven G	USA	NE	Lincoln
260	Regional Cancer Care Associates, LLC/Cherry Hill Division	Greenberg, Richard	USA	NJ	Cherry Hill
261	Clinical Research Alliance, Inc.	Arena, Frances	USA	NY	Lake Success
262	Tulsa Cancer Institute	Buck, Steven C	USA	OK	Tulsa
263	University Hospitals Of Cleveland	Dowlati, Afshin	USA	OH	Cleveland
264	Gabrail Cancer Center	Gabrail, Nashat	USA	OH	Dover
265	Mercy Clinic Oklahoma Communities, Inc	Hampton, James W	USA	OK	Oklahoma City
266	Mid-Ohio Oncology/Hematology, Inc. Dba	Knapp, Mark	USA	OH	Columbus
267	Memorial Sloan-Kettering Cancer Center	Pietanza, Maria C	USA	NY	New Yor
268	Signal Point Clinical Research Center, Llc	Vrindavanam, Nandagopal S	USA	OH	Middletown
269	Oncology Hematology Care, Incorporated	Waterhouse, David	USA	OH	Cincinnati
270	Chattanooga Oncology Hematology Associates	Daniel, Davey	USA	TN	Chattanooga
271	Tennessee Cancer Specialists	DeVore III, Russell	USA	TN	Knoxville
272	Associated in Oncology and Hematology	Gandhi, Jitendra	USA	TN	Chattanooga
273	Henry-Joyce Cancer Center	Horn, Leora	USA	TN	Nashville
274	The Jones Clinic, Pc	Jones, C. Michael	USA	TN	Germantown
275	Kaiser Permanente	Rarick, Mark Urban	USA	OR	Portland
276	Providence Portland Medical Center	Sanborn, Rachel	USA	OR	Portland
277	Tennessee Oncology, Pllc	Spigel, David	USA	TN	Nashville
278	London Regional Cancer Centre	Vincent, Mark D	USA	On	London
279	Virginia Commonwealth University	Baker, Jr., Sherman	USA	VA	Richmond
280	Texas Oncology	Forero, Leonardo	USA	TX	Bedord
281	University Of Texas, M. D. Anderson Cancer Center	Gold, Kathryn	USA	TX	Houston
282	Joe Arrington Cancer Research And Treatment Center	Tafur, Isaac	USA	TX	Lubbock
283	Peninsula Cancer Institute	Tillinghast, Guy W	USA	VA	Newport News
284	Texas Oncology Sammons Cancer Center	Uyeki, James	USA	TX	Dallas
285	Virginia Cancer Institute	Voelzke, Will	USA	VA	Mechanicsville
286	Mary Babb Randolph Cancer Center	Almubarak, Mohammed	USA	WV	Morgantown
287	Providence Regional Medical Center Everett	Saikaly, Elie	USA	WA	Everett

序号	名称	审查结论	批准日期/备案日期
1	吉林省肿瘤医院伦理委员会	同意	2013-07-30

已完成

目标入组人数	国内: 165 ； 国际: 1100 ；
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: 97  ； 国际: 1090 ；

第一例受试者签署知情同意书日期	国内：2013-08-26；     国际：2012-02-22；
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：2017-05-16；     国际：2017-05-16；