CTR20130572 试验状态 已完成 首次公示信息日期...
Transcript of CTR20130572 试验状态 已完成 首次公示信息日期...
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
一、题目和背景信息
登记号 CTR20130572
相关登记号
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 企业选择不公示
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
版本日期
方案是否为联合用
药
企业选择不公示
二、申请人信息
申请人名称 Bristol-Myers Squibb Company
Bristol-Myers Squibb Holdings Pharma Ltd.
百时美施贵宝(中国)投资有限公司
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 [email protected]
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
三、临床试验信息
1、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
2、试验设计
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
3、受试者信息
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
4、试验分组
试验药 序号 名称 用法
1. 中文通用名泰素: 用法用量:企业选择不公示
2. 中文通用名紫杉醇
(BMS):
用法用量:企业选择不公示
3. 中文通用名卡铂
(BMS):
用法用量:企业选择不公示
4. 中文通用名
Ipilimumab注射液
(BMS):
用法用量:企业选择不公示
5. 中文通用名卡铂: 用法用量:企业选择不公示
6. 中文通用名
Ipilimumab注射液
(BMS):
用法用量:企业选择不公示
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 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
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:
AUC 6,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 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
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 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
5、终点指标
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
6、数据安全监
查 委 员 会
(DMC)
有
7、为受试者购
买试验伤害保
险
有
四、研究者信息
1、主要研究者信息
姓
名
张力 学位
职
称
主任医师 电话 86-20-87343458
Em
ail
[email protected] 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
2、各参加机构信息
序
号
机构名称 (主要)研究者 国家 省(州)-城市
1 广东省人民医院 中国 广东 -广州
2 中山大学肿瘤防治中
心
张力 中国 广东 -广州
3 天津市肿瘤医院 李凯 中国 天津 -天津
4 北京协和医院 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 军事医学科学院附属
医院
中国 北京 -北京
7 中国医学科学院肿瘤
医院
中国 北京 -北京
8 中国医学科学院肿瘤
医院
石远凯 中国 北京 -北京
9 北京大学肿瘤医院 中国 北京 -北京
10 北京大学肿瘤医院 王洁 中国 北京 -北京
11 西安交通大学医学院
第一附属医院
南克俊 中国 陕西 -西安
12 西安交通大学医学院
第一附属医院
中国 陕西 -西安
13 吉林省肿瘤医院 中国 吉林 -长春
14 吉林省肿瘤医院 程颖 中国 吉林 -长春
15 同济大学附属上海市
肺科医院
中国 上海 -上海
16 同济大学附属上海市
肺科医院
周采存 中国 上海 -上海
17 浙江大学医学院附属
邵逸夫医院
中国 浙江 -杭州
18 浙江大学医学院附属
邵逸夫医院
潘宏铭 中国 浙江 -杭州
19 中国人民解放军第八
一医院
中国 江苏 -南京
20 中国人民解放军第八
一医院
秦叔逵 中国 江苏 -南京
21 四川大学华西医院 中国 四川 -成都
22 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
23 中国人民解放军第四
军医大学唐都医院
中国 陕西 -西安
24 新疆医科大学附属肿
瘤医院
刘春玲 中国 新疆 -乌鲁木齐
25 中国人民解放军总医 李方 中国 北京 -北京
院
26 新疆医科大学附属肿
瘤医院
中国 新疆 -乌鲁木齐
27 中国人民解放军总医
院
中国 北京 -北京
28 中国医科大学附属第
一医院
刘云鹏 中国 辽宁 -沈阳
29 中国医科大学附属第
一医院
中国 辽宁 -沈阳
30 苏州大学附属第一医
院
陶敏 中国 江苏 -苏州
31 浙江大学医学院附属
第二医院
袁瑛 中国 浙江 -杭州
32 苏州大学附属第一医
院
中国 江苏 -苏州
33 浙江大学医学院附属
第二医院
中国 浙江 -杭州
34 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
35 汕头大学医学院附属
肿瘤医院
林雯 中国 广东 -汕头
36 华中科技大学同济医
学院附属协和医院
中国 湖北 -武汉
37 汕头大学医学院附属
肿瘤医院
中国 广东 -汕头
38 江苏省肿瘤医院 陈嘉 中国 江苏 -南京
39 上海交通大学附属胸
科医院
韩宝惠 中国 上海 -上海
40 江苏省肿瘤医院 中国 江苏 -南京
41 北京协和医院 王孟昭 中国 北京 -北京
42 上海交通大学附属胸
科医院
中国 上海 -上海
43 天津市肿瘤医院 中国 天津 -天津
44 广东省人民医院 吴一龙 中国 广东 -广州
45 Sanatorio Parque
S.A. Privado
Ahualli,
Alejandro
Argentin
a
CORDOBA -Cordoba
46 Centro Oncologico
De Intergracion
Regional
Arboit, Lino Argentin
a
MENDOZA -Mendoza
47 Centro
Esecializado Isis
Blajman, Cesar
Raul
Argentin
a
SANTA FE -Santa Fe
48 Sanatorio Parque Brown Arnold,
Mario
Argentin
a
SANTA FE -Rosario
49 Centro Para La
Atencion Integral
Del Paciente
Oncologico
Palazzo, Felipe
Salvador
Argentin
a
TUCUMAN -San
Miguel De Tucuman
50 Instituto
Oncologico De
Cordoba
Richardet,
Martin Eduardo
Argentin
a
CORDOBA -Cordoba
51 Cer Instituto
Medico
Varela, Mirta
Susana
Argentin
a
BUENOS AIRES
-Quilmes
52 North Coast Cancer Boyce, Adam Australi
a
Victoria -Lismore
53 Peninsula Oncology
Centre
Ganju, Vinod Australi
a
Victoria
-Frankston
54 Austin Hospital John, Thomas Australi
a
Victoria
-Heidelberg
55 Flinders Medical
Centre
Karapetis,
Christos Stelios
Australi
a
South Australia
-Bedford Park
56 Box Hill Hospital Parente, Phillip Australi
a
Victoria -Box
Hill
57 Border Medical
Oncology
Underhill, Craig
Richard
Australi
a
Victoria -Wodonga
58 Mount Medical
Centre, Perth
Oncology
Van Hazel, Guy Australi
a
Western Australia
-Perth
59 Krankenhaus Der
Elisabethinen Linz
GmbH
Bolitschek,
Josef
Austria Linz -Linz
60 Salzburger
Landeskliniken Lkh
Greil, Richard Austria Salzburg
-Salzburg
61 Allgemeines
Krankenhaus Linz
Kropfmuller,
Roland
Austria Linz -Linz
62 Medizinische
Universitaet Graz,
Olschewski,
Horst
Austria Graz -Graz
63 Centre Hospitalier
Regional De La
Citadelle
Bustin,
Frederique
Belgium Liege -Liege
64 Az Nikolaas Deschepper, Koen Belgium Sint Niklaas
-Sint Niklaas
65 Cliniques
Universitaires Ucl
De Mont-Godinne
Ocak, Sebahat Belgium Yvoir -Yvoir
66 Algemeen Stedelijk
Ziekenhuis Aalst
Van Moorter,
Lutgart
Belgium Aalst -Aalst
67 Onze Lieve Vercauter, Piet Belgium Aalst -Aalst
Vrouwenziekenhuis
Campus Aalst
68 Oncoclinic -
Clinica De
Oncologia E
Atendimento De
Urgencia
Alencar, Victor
Hugo
Brazil Ceara -Fortaleza
69 Liga Paranaense De
Combate Ao Cancer
Erasto Gaertner
De Oliveira,
Fabricio Augusto
Brazil Parana -Curitiba
70 Instituto Ribeirao
Pretano De Combate
Ao Cancer - Irpcc
Faccio, Adilson
Aparecido
Brazil Sao Paulo
-Ribeirao Preto
71 Instituto De
Oncologia Do Vale
Fernandes,
Henrique Zanoni
Brazil Sao Paulo -Sao
Jose dos Campos
72 Instituto De
Assistencia Medica
Ao Servidor Publico
Estadual
Gampel, Otavio Brazil Sao Paulo -Sao
Paulo
73 Hospital Da Cidade Lazaretti,
Nicolas
Brazil Rio Grande do Sul
-Passo Fundo
74 Gram Grupo De
Assistencia Medica
E Prestacao De
Servicos
Pereira, Jose
Rodrigues
Brazil Sao Paulo -Sao
Paulo
75 Trymed-Biocancer
Centro de Pesquisa
Clinica S.A.
Portella, Marcos Brazil Belo Horizonte
-Belo Horizonte
76 Fundacao Pio Xii
Hosp Cancer De
Barretos
Silva, Carlos
Maciel
Brazil Sao Paulo
-Barretos
77 Hospital Sao
Vicente De Paulo
Vacaro, Giovana Brazil Rio Grande Do Sul
-Passo Fundo
78 Instituto Nacional
Do Cancer - Inca
Victorino, Ana
Paula
Brazil Rio de janeiro
-Rio de Janeiro
79 Clinionco Vinholes,
Jeferson
Brazil Rio Grande Do Sul
-Porto Alegre
80 Jewish General
Hospital
Cohen, Victor Canada Qc -Montreal
81 Hopital Du
Sacre-Coeur De
Montreal
Cohen, Victor
Diaconescu,
Razvan
Canada Qc -Montreal
82 Gerald Bronfman
Centre
Hirsh, Vera Canada Qc -Montreal
83 Reg Cancer Program
Of The Hopital De
Sudbury Regional
Hosp
Noble, Jonathan
C.S
Canada On -Sudbury
84 Lakeridge Health RS
McLaughlin Durham
Regional Cancer
Centre
Wierzbicki,
Rafal
Canada Oshawa -Oshawa
85 Instituto Nacional
Del Cancer
Aren Frontera,
Osvaldo
Chile METROPOLITANA
-Santiago
86 Centro De
Investigacion
Clinica
Gonzalez Mella,
Pablo
Chile METROPOLITANA
-Santiago
87 Instituto
Oncologico Clinica
Renaca
Gonzalez Mella,
Pablo
Chile VALPARAISO -Vina
Del Mar
88 Clinica Santa Maria Orellana
Ulunque, Eric
Chile METROPOLITANA
-Santiago
89 Oncomedica S. A. Gonzalez, Manuel Colombia CORDOBA -Monteria
90 Fundacion
Cardiovascular De
Colombia
Insuasty, Jesus
S
Colombia SANTANDER
-Bucaramanga
91 Oncologos De
Occidente S.A
Rojas, Gustavo
Adolfo
Colombia RISARALDA
-Pereira
92 Nemocnice na
Bulovce
Havel, Libor Czech
Republic
Prague 8 - Liben
-Prague 8 - Liben
93 Oblastni Nemocnice
Pribram, A.S.
Jakesova, Jitka Czech
Republic
Pribram -Pribram
94 Fn Motol,
Pneumologicka
Klinika Uk
Koubkova, Leona Czech
Republic
Praha 5 -Praha 5
95 Nemocnice Znojmo,
Odd. Radiacni A
Klinicke Onkologie
Krizan, Karol Czech
Republic
Znojmo -Znojmo
96 MasarykovaNemocnic
e V Usti Nad Labem
Reiterer, Pavel Czech
Republic
Usti Nad Labem
-Usti Nad Labem
97 Fakultni Nemocnice
Ostrava
Roubec, Jaromir Czech
Republic
Ostrava -Ostrava
98 General University
Hospital in Prague
Zemanova, Milada Czech
Republic
Prague 2 -Prague 2
99 Herlev Hospital Holm, Bente Denmark Herlev -Herlev
100 Odense University
Hospital
Holmskov Hansen,
Karin
Denmark Odense -Odense
101 Naestved Hospital Ingeberg, Steen Denmark Naestved
-Naestved
102 Aalborg Hospital Mcculloch, Tine Denmark Aalborg -Aalborg
103 Hillerod Hospital Nielsen, Henrik
Anker
Denmark Hillerod
-Hillerod
104 Hopital Nord Barlesi, Fabrice France Marseille Cedex
20 -Marseille
Cedex 20
105 Chu Toulouse Bigay-Game,
Laurence
France Toulouse Cedex 9
-Toulouse Cedex 9
106 Centre Hospitalier
Intercommunal de
Creteil
Chouaid,
Christos
France Creteil -Creteil
107 Hopital De Brabois Clement-Duchene
, Christelle
France Vandoeuvre-les-n
ancy
-Vandoeuvre-les-
nancy
108 Centre Francois
Baclesse
Gervais, Radj France Caen -Caen
109 Chu De Poitiers Lamour, Corinne France Poitiers
-Poitiers
110 Chu Pontchaillou Lena, Herve France Rennes Cedex 9
-Rennes Cedex 9
111 Groupe Hospitalier
Paris St-Joseph
Tredaniel, Jean France Paris -Paris
112 Augusta-Kranken-An
stalt Ggmbh
Behringer, Dirk Germany Bochum -Bochum
113 Klinikum Darmstadt
GmbH
Bernhard, Helga Germany Darmstadt
-Darmstadt
114 Universitatsklinik
um Schleswig
Holstein
Bohnet, Sabine Germany Lubeck -Lubeck
115 Klinikum Nuernberg Brueckl,
Wolfgang
Germany Nuernberg
-Nuernberg
116 Schwarzwald Baar
Klinikum
Brugger, Wolfram Germany Villingen
Schwenningen
-Villingen
Schwenningen
117 Kliniken Der Stadt
Koeln Ggmbh
Krankenhaus
Mehrheim
Chemaissani,
Assaad
Germany Koeln -Koeln
118 Asklepios Klinik
Harburg
Lungenabteilung
Eschbach,
Corinna
Germany Hamburg -Hamburg
119 Universitaetsklini
kum Carl Gustav
Carus
Folprecht,
Gunnar
Germany Dresden -Dresden
120 Klinikum Der Johann
Wolfgang
Goethe-Universitat
Gleiber,
Wolfgang
Germany Frankfurt am Main
-Frankfurt am
Main
121 Pius-Hospital
Oldenburg
Griesinger,
Frank
Germany Oldenburg
-Oldenburg
122 Friedrich Ebert
Krankenhaus Gmbh
Held, Harald Germany Neumunster
-Neumunster
123 Medizinische
Universitaetsklini
k Tuebingen
Kopp, Hans-Georg Germany Tuebingen
-Tuebingen
124 Universitaetsklini
kum Ulm
Lee, Mi Kyung Germany Ulm -Ulm
125 Krankenhaus
Grosshansdorf Gmbh
Reck, Martin Germany Grosshansdorf
-Grosshansdorf
126 Zentralklinik Bad
Berka Gmbh
Schneider,
Claus-Peter
Germany Bad Berka -Bad
Berka
127 Klinikum
Bogenhausen
Schuetz, Martin Germany Muenchen
-Muenchen
128 Lungenklinik Hemer Serke, Momika Germany Hemer -Hemer
129 Krankenhaus
Barmherzige
Brueder Regensburg
Stauder,
Heribert
Germany Regensburg
-Regensburg
130 Thoraxklinik-Heide
lberg Ggmbh
Thomas, Michael Germany Heidelberg
-Heidelberg
131 Asklepius
Fachkliniken
Von Pawel,
Joachim
Germany Gauting -Gauting
132 Universitaetsmediz
in Der Johannes
Gutenberg-Universi
taet
Wehler, Thomas Germany Mainz -Mainz
133 Klinikum Kassel
Gmbh
Wolf, Martin Germany Kassel -Kassel
134 Pamela Youde
Nethersole Eastern
Hospital
Chan, Siu Hong 中国 香港 -香港
135 Queen Mary Hospital Ho, Chung Man
James
中国 香港 -香港
136 Tuen Mun Hospital Lo, Sing Hung 中国 香港 -香港
137 Queen Elizabeth
Hospital
Yau, Stephen 中国 香港 -香港
138 Matrai Albert, Istvan Hungary Matrahaza
Gyogyintezet -Matrahaza
139 Sopron Megyei Jogu
Varos Erzsebet
Oktato Korhaz
Bartfai, Zoltan Hungary Sopron -Sopron
140 Jasz-Nagykun-Szoln
ok Megyei Hetenyi
Geza
Korhaz-Rendelointe
z
Csoszi, Tibor Hungary Szolnok -Szolnok
141 Semmelweis
Egyetem,
Pulmonologiai
Klinika
Losonczy, Gyorgy Hungary Budapest
-Budapest
142 Veszprem Megyei
Onkormanyzat
Tudogyogyintezete
Medgyasszay,
Balazs
Hungary Farkasgyepu
-Farkasgyepu
143 Orszagos Koranyi
Tbc Es
Pulmonologiai
Intezet
Ostoros, Gyula Hungary Budapest
-Budapest
144 Fejer Megyei Szent
Gyorgy Korhaz
Papai-Szekely,
Zsolt
Hungary Szekesfehervar
-Szekesfehervar
145 Pte Klinikai
Kozpont 1.Sz.
Belgyogyaszati
Klinika, Pulmonolo
Sarosi, Veronika Hungary Pecs -Pecs
146 Csongrad Megyei
Onkormanyzat
Mellkasi
Betegsegek
Szakkorhaza
Somfay, Attila Hungary Deszk -Deszk
147 Josa Andras
Oktatokorhaz
Szabo, Peter Hungary Nyiregyhaza
-Nyiregyhaza
148 Bekes Megyei
Kepviselotestulet
Pandy Kalman Korhaz
Sztancsik,
Zsuzsanna
Hungary Gyula -Gyula
149 Pest Megyei
Tudogyogyintezet
Tolnay, Edina Hungary Torokbalint
-Torokbalint
150 St James Hospital Cuffe, Sinead Ireland Dublin -Dublin
151 GalWay University
Hospital
Donnellan, Paul Ireland Galway -Galway
152 St Vincent's
University
Hospital
Hanrahan, Emer Ireland Dublin -Dublin
153 Adelaide Meath
National Childrens
Hospital
Mcdermott, Ray Ireland Dublin -Dublin
154 The Soroka
University Medical
Center
Ariad, Samuel Israel Beer Sheva -Beer
Sheva
155 Assaf Harofeh
Medical Center
Cyjon, Arnold Israel Zerifin -Zerifin
156 Meir Medical Center Gottfried, Maya Israel Kfar Saba -Kfar
Saba
157 Assuta Medical
Center, Oncology
Department
Jiveliouk, Irina Israel Tel-aviv
-Tel-aviv
158 Oncology
Institute, Kaplan
Medical Center
Katsnelson,
Rivka
Israel Rehovot -Rehovot
159 Tel-Aviv Sourasky
Medical Center
Merimsky, Ofer Israel Tel-aviv
-Tel-aviv
160 Western Galilee
Hospital- Nahariya
Nasrallah,
Suheil
Israel Nahariya
-Nahariya
161 Oncology
Department,
Hadassah Medical
Organization
Nechushtan,
Hovav
Israel Jerusalem
-Jerusalem
162 Oncology
Institute, Sheba
Medical Center
Onn, Amir Israel Ramat-gan
-Ramat-gan
163 The Davidoff
Comprehensive
Cancer Center
Stemmer, Salomon Israel Petah-tikva
-Petah-tikva
164 Oncology
Institute, Rambam
Medical Center
Wollner, Mirjana Israel Haifa -Haifa
165 Ospedale Versilia Amoroso,
Domenico
Italy Lucca -Lido Di
Camaiore
166 Ospedale Campo Di
Marte
Baldini, Editta Italy Lucca -Lucca
167 Azienda
Ospedaliera
Treviglio-Caravagg
io
Barni, Sandro Italy Treviglio
-Treviglio
168 Ospedale Civile Di
Sondrio - Azienda
Ospedaliera Della
Bertolini,
Alessandro
Italy Sondrio -Sondrio
169 Azienda
Ospedaliera - Nuovo
Ospedale San
Gerardo
Bidoli, Paolo Italy Monza -Monza
170 Azienda
Ospedaliera Di
Perugia
Crino, Lucio Italy Perugia -Perugia
171 Ospedale G.Rummo Daniele, Bruno Italy Benevento
-Benevento
172 I.O.V. Istituto
Oncologico Veneto
Ircss
Favaretto,
Adolfo
Italy Padova -Padova
173 Azienda
Ospedaliera
Universitaria
Senese
Maio, Michele Italy Siena -Siena
174 Policlinico S.
Orsola Malpighi
Melotti, Barbara Italy Bologna -Bologna
175 Ospedale S.Maria Roila, Fausto Italy Terni -Terni
176 Miyagi Cancer
Center
Fukuhara,
Tatsuro
Japan Miyagi
-Natori-shi
177 Aichi Cancer Center
Central Hospital
Hida, Toyoaki Japan Aichi -Nagoya
178 Kanazawa
University
Hospital
Kasahara, Kazuo Japan ISHIKAWA
-Kanazawa-shi
179 Kanagawa
Cardiovascular and
Respiratory Center
Kato, Terufumi Japan Kanagawa
-Yokohama-Shi
180 National Cancer
Center Hospital
East
Ohmatsu,
Hironobu
Japan CHIBA -Kashiwa
181 Yokohama Municipal
Citizen's
Hospital/Respirato
ry Internal
Medicine
Okamoto, Hiroaki Japan Kanagawa
-Yokohama-Shi
182 National Hospital
Organization
Nagoya Medical
Center
Saka, Hideo Japan Aichi -Nagoya-shi
183 National Nagoya
Hospital
Saka, Hideo Japan Aichi -Nagoya-shi
184 Kyushu University Takayama, Koichi Japan FUKUOKA
Hospital -Fukuoka-shi
185 National Hospital
Organization
Kyushu Med Ctr
Takenoyama,
Mitsuhiro
Japan FUKUOKA
-Fukuoka-shi
186 Osaka Medical
College Hospital
Fujisaka,
Yasuhito
Japan OSAKA
-Takatsuki-shi
187 Kansai Medical
University
Hirakata Hospital
Kurata, Takayasu Japan OSAKA
-Hirakata-shi
188 Shizuoka Cancer
Center
Naito, Tateaki Japan Shizuoka
-Sunto-gun
189 Kinki University
School Of Medicine
Nakagawa,
Kazuhiko
Japan OSAKA
-Osaka-sayama-sh
i
190 Kawasaki Medical
School Hospital
Oka, Mikio Japan OKAYAMA
-Kurashiki City
191 Osaka City General
Hospital
Takeda, Koji Japan OSAKA -Osaka-shi
192 Kurashiki Central
Hospital
Yoshioka,
Hiroshige
Japan OKAYAMA
-Kurashiki-shi
193 Yamaguchi Ube
Medical Center
Chikamori,
Kenichi
Japan Yamaguchi
-Ube-shi
194 Hokkaido Cancer
Center
Harada, Masao Japan Sapporo, Hokkaido
-Sapporo,
Hokkaido
195 Tohoku University
Hospital
Inoue, Akira Japan Sendai -Sendai
196 Hokkaido
University
Hospital
Kinoshita,
Ichiro
Japan Sapporo, Hokkaido
-Sapporo,
Hokkaido
197 Shikoku Cancer
Center
Kozuki,
Toshiyuki
Japan Matsuyama, Ehime
-Matsuyama, Ehime
198 Cancer Institute
Hospital Of Jfcr
Nishio, Makoto Japan Tokyo -Koto-ku
199 Hyogo Cancer Center Satouchi, Miyako Japan Akashi, Hyogo
-Akashi, Hyogo
200 Sendai Kosei
Hospital
Sugawara,
Shunichi
Japan Sendai, Miyagi
-Sendai, Miyagi
201 National Cancer
Center Hospital
Yamamoto, Noboru Japan Tokyo -Chuo-ku
202 Div Of Hematology &
Oncology, Dept Of
Med, Samsung Med
Cntr
Ahn, Myung Ju Republic
of Korea
Seoul -Seoul
203 Gangnam Severance
Hospital, Younsei
University Health
System
Cho, Jae Yong Republic
of Korea
Seoul -Seoul
204 Pusan National
University
Hospital
Choi, Young Jin Republic
of Korea
BUSAN -BUSAN
205 Chung-Ang
University
Hospital
Jang, Joung Soon Republic
of Korea
Seoul -Seoul
206 Seoul St. Mary'S
Hospital, The
Catholic
University Of Korea
Kang, Jin-Hyoung Republic
of Korea
Seoul -Seoul
207 VHS Medical Center Kim, Bong-Seong Republic
of Korea
Seoul -Seoul
208 Seoul National
University
Hospital
Kim, Dong Wan Republic
of Korea
Seoul -Seoul
209 The Catholic
University Of Korea
St. Vincent'S Hosp
Kim, Hoon Kyo Republic
of Korea
GYEONGGI-DO
-Suwon-si
210 Severance
Hospital, Yonsei
University Health
System
Kim, Joo-Hang Republic
of Korea
Seoul -Seoul
211 Asan Medical Center Kim, Sang-We Republic
of Korea
Seoul -Seoul
212 Ajou University
Hospital
Lee, Hyun Woo Republic
of Korea
GYEONGGI-DO
-Suwon
213 Seoul National
University Bundang
Hospital
Lee, Jong Seok Republic
of Korea
Seongnam-si
-Seongnam-si
214 Chungbuk National
University
Hospital
Lee, Ki Hyeong Republic
of Korea
Cheogju-si
-Cheogju-si
215 National Cancer
Center
Lee, Young Joo Republic
of Korea
GYEONGGI-DO
-Goyang-si
216 Korea University
Anam Hospital
Shin, Sang Won Republic
of Korea
Seoul -SEOUL
217 Keimyung
University Dongsan
Medical Center
Song, Hong Suk Republic
of Korea
Daegu -Daegu
218 Hospital Y Clinica Gonzalez-Perez, Mexico Nuevo Leon
Oca Jose Luis -Monterrey
219 Althian Research
Management Center
Medina-Soto,
Francisco Alejo
Mexico Nuevo Leon
-Monterrey
220 Hospital General De
Occidente
Mondragon,
Rogelio
Mexico Jalisco -Zapopan
221 Centro Medico
Dalinde
Villalobos-Vale
ncia, Ricardo
Mexico Distrito Federal
-Mexico
222 Amphia Ziekenhuis
( Amphia Hospital)
Aerts, Joachim Netherla
nds
Breda -Breda
223 Jeroen Bosch
Ziekenhuis (Jeroen
Bosch Hospital)
Biesma, Bonne Netherla
nds
's-Hertogenbosch
-'s-Hertogenbosc
h
224 St. Jansdal
Ziekenhuis
Gans, Steven
S.J.M
Netherla
nds
Harderwijk
-Harderwijk
225 St. Antonius
Hospital
Herder, Judith
G.J.M
Netherla
nds
Nieuwegein
-Nieuwegein
226 Vu University
Medical Center
Smit, Egbert F Netherla
nds
Amsterdam
-Amsterdam
227 Hospital Nacional
Dos De Mayo/ Unidad
De Quimioterapia
Chumbes, Mirna Peru Lima -Lima
228 Hospital Nacional
Edgardo Rebagliati
Martins
Figueroa,
Alejandro
Peru Lima -Lima
229 Hospital Nacional
Carlos Alberto
Seguin
Escobedo-Essalud
Giraldez, Jorge
Becerra
Peru Arequipa
-Arequipa
230 Clinica Peruano
Americana / Centro
De Invest. Clin
Trujillo
Zorrilla, Jose Peru LA LIBERTAD
-Trujillo
231 Centrum Onkologii-
Oddzial Kliniczny
Onkologii
Chmielowska, Ewa Poland Bydgoszcz
-Bydgoszcz
232 Uniwersyteckie
Centrum Kliniczne,
Klinika
Nefrologii,Transpl
Jassem, Jacek Poland Gdansk -Gdansk
233 Spz Gruzlicy I
Chorob Pluc W
Olsztynie
Kazarnowicz,
Andrzej
Poland Olsztyn -Olsztyn
234 Centrum Onkologii -
Instytut Im. Marii
Krzakowski,
Maciej
Poland Warszawa
-Warszawa
Sklodowskiej-Curie
235 Szpital Morski Im.
Pck
Lesniewski-Kmak
, Krzysztof
Poland Gdynia -Gdynia
236 Wojewodzkie
Centrum Onkologii
Sp Zoz
Nowaczyk, Monika Poland Gdansk -Gdansk
237 Szpital Im. St.
Leszczynskiego
Poborski,
Wojciech
Poland Katowice
-Katowice
238 Oddzial Onkologii
Klinicznej
Ramlau, Rodryg Poland Poznan -Poznan
239 Wojewodzki Szpital
Zespolony W Elblagu
Ryniewicz-
Zander, Iwona
Poland Elblag -Elblag
240 Regionalny Szpital
Specjalistyczny W
Grudziadzu
Sadowska, Uszula Poland Grudziadz
-Grudziadz
241 Wojewodzki Szpital
Zespolony Im. L.
Rydygiera W Toruniu
Sawrycki, Piotr Poland Torun -Torun
242 Specjalistyczny
Szpital Im. Prof.
Alfreda
Sokolowskiego
Sawrycki, Piotr
Serwatowski,
Piotr
Poland Szczecin
-Szczecin
243 Mazowieckie
Centrum Leczenia
Chorob Pluc I
Gruzlicy
Szczesna,
Aleksandra
Poland Otwock -Otwock
244 Inst Portugues De
Oncologia De Lisboa
Francisco
Gentil,E.P.E
Almodovar,
Teresa
Portugal LISBOA -Lisboa
245 Centro Hospitalar
De Entre O Douro E
Vouga, Epe
Araujo, Antonio Portugal SANTA MARIA DA
FEIRA -Santa
Maria Da Feira
246 Centro Hospitalar
De Coimbra
Barata, Fernando Portugal Coimbra -Coimbra
247 Centro Hospitalar
De Vila Nova De
Gaia/Espinho, Epe
Parente, Barbara Portugal Vila Nova De Gaia
-Vila Nova De Gaia
248 Inst Portugues De
Oncologia Do Porto
Francisco Gentil,
E.P.E
Soares, Marta Portugal PORTO -Porto
249 Centro Hospitalar
Lisboa Norte, Epe -
Teixeira, Maria
Encarnacao
Portugal LISBOA -Lisboa
Hospital De Santa
Mari
250 Coltea Clinical
Hospital
Aldea, Ciprian Romania Bucharest
-Bucharest
251 Spitalul Judetean
De Urgenta
Ganea, Doina
Elena
Romania Suceava -Suceava
252 Ianuli Med Consult
Srl
Ianuli,
Carmen-Hariclea
G
Romania Bucuresti
-Bucuresti
253 Oncomed Oprean, Cristina
Marinela
Romania Timisoara, Timis
-Timisoara, Timis
254 Spitalul Judetean
De Urgenta Sibiu
Patran, Monica Romania Sibiu -Sibiu
255 Sc Medisprof Srl Udrea, Anghel
Adrian
Romania Cluj Napoca -Cluj
Napoca
256 Johns Hopkins
International
Medical Centre
Chang, Alex
Yuang-Chi
Singapor
e
Singapore
-Singapore
257 Oncocare Cancer
Centre
Leong, Swan Singapor
e
Singapore
-Singapore
258 Sahlgrenska Ostra
Hospital
Bergman, Bengt Sweden Gothenburg
-Gothenburg
259 Department Of
Oncology
Johansson,
Mikael
Sweden Umea -Umea
260 Skanes University
Hospital
Ohman, Ronny Sweden Lund -Lund
261 Dept Of Oncology Tell, Roger Sweden Stockholm
-Stockholm
262 Guz Republic
Clinical Oncology
Dispensary By Moh
In Tatarst
Akhmetzyanov,
Foat
Russian
Federati
on
Kazan -Kazan
263 Guz Clinical
Oncology
Dispensary #1
Davidenko, Irina Russian
Federati
on
Krasnodar
-Krasnodar
264 State Institution
Of Healthcare
Divnogortseva,
Leniza
Russian
Federati
on
Tula -Tula
265 Russian Scientific
Center Of
Rentgenoradiology
Dobrovolskaya,
Natalia
Russian
Federati
on
Moscow -Moscow
266 Chelyabinsk
Regional Oncology
Dispensary
Gladkov, Oleg Russian
Federati
on
Chelyabinsk
-Chelyabinsk
267 Russian Oncology
Research Center
Named After Blokhin
N.N.
Gorbunova, Vera Russian
Federati
on
Moscow -Moscow
268 City Clinical
Oncology
Dispensary
Karaseva, Nina Russian
Federati
on
St-Peterburg
-St-Peterburg
269 Samara Regional
Oncology
Dispensary
Kopp, Mikhail Russian
Federati
on
Samara -Samara
270 Russian
Oncological
Research Center
N.A. N.N. Blokhin
Rams
Lichinitser,
Mikhail
Russian
Federati
on
Moscow -Moscow
271 Saint Petersburg
State Medical
University
Mosin, Igor Russian
Federati
on
St. Petersburg
-St. Petersburg
272 Republic Clinical
Oncology
Dispensary of
Ministry of Health
of Republic
Tatarsta
Mukhametshina,
Guzel
Russian
Federati
on
Kazan -Kazan
273 NII Oncology n.a.
N.N. Petrov
Protsenko,
Svetlana
Russian
Federati
on
Saint Petersburg
-Saint Petersburg
274 FGBU Med. Radiol.
Research Centre of
Rus. Ministry of
Health
Ragulin, Yury Russian
Federati
on
Obninsk -Obninsk
275 Fgu Hospital With
Polyclinic
Severtsev,
Alexey
Russian
Federati
on
Moscow -Moscow
276 State Healthcare
Inst. Pyatigorsk
Oncology
Dispensary
Vladimirov,
Vladimir
Russian
Federati
on
Pyatigorsk
-Pyatigorsk
277 Department Of
Radiation Oncology
Dalvie, Sameera South
Africa
WESTERN CAPE
-Observatory
278 GVI Oncology
Clinical Trials
Unit
Jacobs, Conrad South
Africa
WESTERN CAPE
-Panorama,cape
Town
279 G V I Oncology, Harris, Jill South WESTERN CAPE
Rondebosch
Oncology Centre
Africa -Rondebosch
280 Hopelands Cancer
Centre
Mall, Riaz South
Africa
KWA ZULU NATAL
-Durban
281 Vaal Triangle
Oncology-Alberts,
Bouwer & Jordaan
Inc.
Rens, Daniel South
Africa
EASTERN CAPE
-Vereeniging
282 Centre
Pluridisciplinaire
D'Oncologie Centre
Hosp Univ
Peters, Solange Switzerl
and
Lausanne
-Lausanne
283 Kantonsspital
Winterthur
Pless, Miklos Switzerl
and
Winterthur
-Winterthur
284 Onkologiezentrum
Thun-Berner
Oberland Spital Sts
Ag
Rauch, Daniel Switzerl
and
Thun -Thun
285 University
Hospital Basel
Zippelius,
Alfred
Switzerl
and
Basel -Basel
286 Hospital Nuestra
Senora. De Sonsoles
Ales Martinez,
Jose Enrique
Spain Avila -Avila
287 Hospital General
Univ De Valencia
Camps Herrero,
Carlos
Spain Valencia
-Valencia
288 Althaia Xarxa
Assistencial De
Manresa
Catot Tort,
Silvia
Spain Manresa -Manresa
289 Hospital Clinical
Benidorm
Esquerdo
Galiana, Gaspar
Spain Benidorm-alicant
e
-Benidorm-alican
te
290 Hospital Santa
Maria Nai
Firvida Perez,
Jose
Spain Ourense -Ourense
291 Hospital Arnau De
Vilanova
Garcia-Sanchez,
Jose
Spain Valencia
-Valencia
292 Hospital 12 De
Octubre
Iglesias
Docampo, Lara
Carmen
Spain Madrid -Madrid
293 Hospital De Mataro Lianes, Pilar Spain Barcelona
-Barcelona
294 Hospital De Cruces Lopez-Vivanco,
Guillermo
Spain Vizcaya -Vizcaya
295 Hospital
Provincial De
Sanchez
Hernandez,
Spain Castellon
-Castellon
Castellon Alfredo
296 Hospital Md
Anderson
Sanchez Torres,
Jose Miguel
Spain Madrid -Madrid
297 Taichung Veterans
General Hospital
Chang, Gee-Chen 中国 台湾 -Taichung
298 China Medical
University
Hospital
Hsia, Te-Chun 中国 台湾 -Taichung
City
299 Chang Gung Medical
Foundation, Linkou
Branch
Kuo, Han-Pin 中国 台湾 -Taoyuan
300 Changhua Christian
Hospital
Li, Chien-Te 中国 台湾 -Changhua
301 Chang Gung Medical
Foundation-Chiayi
Branch
Lu, Chang-Hsien 中国 台湾 -Chiayi
302 Taipei Veterans
General Hospital
Tsai, Chun-Ming 中国 台湾 -Taipei
303 Chang Gung Medical
Foundation-Kaohsiu
ng Branch
Wang, Chin-Chou 中国 台湾 -Kaohsiung
304 National Taiwan
University
Hospital
Yu, Chong-Jen 中国 台湾 -Taipei
305 National Cancer
Institute, Medical
Oncology Unit
Arpornwirat,
Wichit
Thailand Bangkok -Bangkok
306 Holistic Center For
Cancer Study And
Care (Hocc-Psu)
Dechaphunkul,
Arunee
Thailand Songkla -Songkla
307 Phramongkutklao
Hospital
Seetalarom,
Kasan
Thailand Bangkok -Bangkok
308 Division Of Medical
Oncology Unit,
Department Of
Medicine
Srimuninnimit,
Vichien
Thailand Bangkok -Bangkok
309 Faculty Of
Medicine,
Chulalongkorn
University
Sriuranpong,
Virote
Thailand Bangkok -Bangkok
310 Div. Of Medical
Oncology, Dept. Of
Medicine, Faculty
Of Med
Thongprasert,
Sumitra
Thailand Chiang Mai
-Chiang Mai
311 Royal Surrey County
Hospital
Middleton, Gary United
Kingdom
Surrey -Guildford
312 Southampton
University
Hospital Nhs Trust
Ottensmeier,
Christian
United
Kingdom
Hampshire
-Southampton
313 The Royal Marsden
Hospital
Popat, Sanjay United
Kingdom
Greater London
-London
314 Nottingham
University
Hospitals Nhs Trust
Potter, Vanessa United
Kingdom
Nottinghamshire
-Nottingham
315 Ninewells Hospital
And Medical School
Rankin, Elaine
Mary
United
Kingdom
Angus/forfarshir
e -Dundee
316 Royal Cornwall
Hospital
Talbot, Toby United
Kingdom
Cornwall -Truro
317 Weston Park
Hospital
Woll, Penella
Jane
United
Kingdom
Sheffield
-Sheffield
318 Sharp Memorial
Hospital
Bodkin, David USA CA -San Diego
319 Hematology & Med
Oncology Of
Southern Palm Beach
County, Inc
Brito, Rogelio
(Roger) A
USA FL -Boynton Beach
320 Va Connecticut
Healthcare System
Chao, Herta USA FL -Newington
321 Floyd Memorial
Cancer Center Of
Indiana
Chowhan, Naveed USA CT -New Albany
322 Lynn Cancer
Institute Center
For
Hematology-Oncolog
y
DeCesare, Teresa USA IN -Boca Raton
323 Integrated
Community Oncology
Network
Dees, Iii,
Morris
USA FL -Jacksonville
324 Indiana University
Cancer Center
Einhorn,
Lawrence
USA FL -Indianapolis
325 Quincy Medical
Group
El-Khoury,
Christian
USA IL -Quincy
326 University Of
Illinois At Chicago
Medical Center
Feldman,
Lawrence
USA IL -Chicago
327 Southern Illinois
University School
Khan,
Aziz-Ur-Rehman
USA IL -Springfield
Of Medicine
328 Orchard Healthcare
Research Inc.
Oliff, Ira Anton USA IL -Skokie
329 St. Francis
Hospital & Health
Centers
Slaughter,
Michael
USA IN -Beech Grove
330 Clinical Research
Alliance, Inc.
Arena, Francis P USA NY -Lake Success
331 Syracuse Va Medical
Center
Gajra, Ajeet USA NY -Syracuse
332 Kentucky Cancer
Clinic
Ghazal, Hassan H USA KY -Hazard
333 Norton Cancer
Institute
Harandi, Amir USA KY -Louisville
334 Durham Va Medical
Center
Kelley, Michael USA NC -Durham
335 Piedmont
Hematology
Oncology
Associates, Pllc
Paschold, Eugene
H
USA NC -Winston Salem
336 Duke University
Medical Center
Potti, Anil USA NC -Butner
337 Carolina
Biooncology
Institute
Powderly Ii,,
John D
USA NC -Huntersville
338 Presbyterian
Hospital Cancer
Research
Reiling, Richard USA NC -Charlotte
339 Montgomery Cancer
Center
Zaydan,
Muhammad-Ali
USA KY -Mount
Sterling
340 Washington
University School
Of Medicine
Baggstrom, Maria USA MO -Saint Louis
341 Oklahoma Oncology
And Hematology, Pc
Dba
Buck, Steven C USA OK -Tulsa
342 Singing River
Health System
Clarkson, James USA MS -Pascagoula
343 University Of
Minnesota
Dudek, Arkadiusz
Z
USA MN -Minneapolis
344 Gabrail Cancer
Center Research
Gabrail, Nashat
Y
USA OH -Dover
345 Warren Cancer
Research
Lynch, Joseph USA OK -Tulsa
Foundation
346 Kansas City Cancer
Centers -South
Pendergrass,
Kelly
USA MO -Kansas City
347 Dartmouth-Hitchcoc
k Medical Center
Rigas, James USA NH -Lebanon
348 St Joseph Mercy
Hospital
Stella, Philip USA MI -Ann Arbor
349 Tennessee Cancer
Specialists
Dobbs, Tracy W USA TN -Knoxville
350 Associated in
Oncology and
Hematology
Gandhi, Jitendra USA TN -Chattanooga
351 Cancer Center Of
The Carolinas
Gluck, William USA SC -Easley
352 Cancer Center At
Cookeville
Regional Medical
Center
Jacquin, Paul N USA TN -Cookeville
353 Thompson Oncology
Group
Mccachren Jr.,
Samuel S
USA TN -Knoxville
354 Providence
Regional Med Cntr
Everett/Cancer
Partnership
Saikaly, Elie USA WA -Everett
355 Texas Oncology, PA
- South Austin
Cancer Center
Uyeki, James USA TX -Austin
356 Wjb Dorn Va Medical
Center
Wallam, Mohammed USA SC -Columbia
357 Blue Ridge Cancer
Care
Goldschmidt,
Jr., Jerome H
USA VA -Salem
358 Guthrie Clinic, Ltd Lash, Bradley USA PA -Sayre
359 Wisconsin
Institutes for
Medical Research
Leal, Ticiana USA WI -Madison
360 Kaiser Permanente
Northwest Region
Rarick, Mark
Urban
USA OR -Portland
361 Cancer Outreach
Associates, Pc
Swan, Jr.,
Forrest
USA VA -Abingdon
五、伦理委员会信息
序号 名称 审查结论 批准日期/审查日期
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 同意 2014-08-15
会
六、试验状态
1、试验状态
已完成
2、试验人数
目标入组人数 国内: 80 人;国际: 920 人;
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 人;国际: 923 人;
3、受试者招募及试验完成日期
第一例受试者签署知情同意书
日期
国内: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
试验完成日期 国内:2015-12-14;国际:2016-12-09
七、临床试验结果摘要
序号 版本号 版本日期