药物临床试验登记与信息公示平台
登记号 Registration number | CTR20222569 | 试验状态 Trial status | 进行中 Ongoing |
---|---|---|---|
申请人联系人 Applicant Contact | 夏言言 Xia Yanyan | 首次公示信息日期 The date on which the information was first published | 2022-10-12 |
申请人名称 Name of applicant | 不适用/ 默克雪兰诺(北京)医药研发有限公司 N/A / Merck Seronno (Beijing) Pharmaceutical R&D Co., Ltd |
一、题目和背景信息 1. Title and background information
登记号 Registration number | CTR20222569 | ||
---|---|---|---|
相关登记号 Relevant registration number | |||
药物名称 The name of the drug |
Xevinapant口服溶液
曾用名:Debio 1143
Xevinapant Oral Solution formerly known as Debio 1143 |
||
药物类型 Type of medication | 化学药物 Chemical drugs | ||
临床申请受理号 Clinical application acceptance number | 企业选择不公示 The company chooses not to make it public | ||
适应症 Indications | Xevinapant联合放疗(RT)适用于具有高复发风险且不适宜含顺铂化疗的已手术切除的局部晚期SCCHN的患者 Xevinapant plus radiotherapy (RT) is indicated for patients with surgically resected locally advanced SCCHN who are at high risk of recurrence and who are not candidates for cisplatin-based chemotherapy |
||
试验专业题目 Experimental professional topics | 一项在具有高复发风险且不适宜高剂量顺铂的已手术切除的头颈部鳞状细胞癌受试者中评估xevinapant和放疗与安慰剂和放疗相比的有效性和安全性并证明无病生存期改善的随机、双盲、安慰剂对照、双臂III期研究 A randomized, double-blind, placebo-controlled, two-arm phase III study to evaluate the efficacy and safety of xevinapant and radiotherapy compared with placebo and radiotherapy and demonstrate improved disease-free survival in subjects with surgically resected head and neck squamous cell carcinoma at high risk of recurrence who are not candidates for high-dose cisplatin |
||
试验通俗题目 Experiment with popular topics | 一项xevinapant和放疗联合治疗具有高风险且不适宜顺铂的已手术切除的LA SCCHN受试者的III期研究 A Phase III study of xevinapant in combination with radiotherapy in subjects with surgically resected LA SCCHN who are at high risk and not candidates for cisplatin |
||
试验方案编号 Protocol number | MS202359_0002 | 方案最新版本号 The latest version of the solution | 第5.0版 Version 5.0 |
版本日期: Version Date: | 2023-07-25 | 方案是否为联合用药 Whether the regimen is a combination of drugs | 否 |
二、申请人信息 2. Applicant's information
申请人名称 Name of applicant |
1
2
|
||||
---|---|---|---|---|---|
联系人姓名 Contact name | 夏言言 Xia Yanyan | 联系人座机 Contact desk phone | 021-22265500 | 联系人手机号 The contact's mobile phone number | 18758189762 |
联系人Email Contact Email | ellie.xia@external.merckgroup.com | 联系人邮政地址 Contact person postal address | 上海市-上海市-浦东新区东育路227弄3号前滩世贸中心(二期)C栋15层 15th Floor, Building C, Qiantan World Trade Center (Phase II), No. 3, Lane 227, Dongyu Road, Shanghai - Pudong New Area |
联系人邮编 Contact zip code | 200126 |
三、临床试验信息 3. Clinical trial information
1、试验目的 1. The purpose of the test
本研究的目的是,证明xevinapant当添加到放疗方案时在不适宜接受以顺铂为基础的放化疗同步治疗的患有已手术切除的LA SCCHN的高风险受试者中的有效性优于安慰剂。
The purpose of this study is to demonstrate that xevinapant, when added to a radiotherapy regimen, is superior to placebo in high-risk subjects with surgically resected LA SCCHN who are not candidates for concomitant cisplatin-based chemoradiotherapy.
2、试验设计 2. Experimental design
试验分类 Classification of trials | 安全性和有效性 Safety and efficacy | 试验分期 Staging of the trial | III期 Stage III | 设计类型 Type of design | 平行分组 Parallel grouping |
---|---|---|---|---|---|
随机化 randomization | 随机化 randomization | 盲法 Blinding | 双盲 Double-blind | 试验范围 Scope of the test | 国际多中心试验 International multicenter trial |
3、受试者信息 3. Subject information
年龄 age | 18岁(最小年龄)至 无上限 (最大年龄) 18 years old (minimum age) to no upper limit (maximum age) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
性别 gender | 男+女 Male + Female | ||||||||||||||||||||||||||||||||||||||||||||||||||||
健康受试者 Healthy subjects | 无 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
入选标准 Inclusion Criteria |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
排除标准 Exclusion Criteria: |
|
4、试验分组 4. Test grouping
试验药 Investigational drug |
|
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
对照药 Comparator |
|
5、终点指标 5. Endpoint indicators
主要终点指标及评价时间 The main endpoint indicators and evaluation time |
|
||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
次要终点指标及评价时间 Secondary endpoint measures and evaluation time |
|
6、数据安全监查委员会(DMC)
6. Data Security Audit Committee (DMC)
有
7、是否购买保险
7. Whether to buy insurance
有
四、研究者信息 4. Investigator information
1、主要研究者信息 1. Information of the principal investigator
1 | 姓名 name | 杨坤禹 Yang Kunyu | 学位 degree | 医学博士 MD | 职称 job title | 正高级 It is advanced |
---|---|---|---|---|---|---|
电话 Phone | 13995595360 | yangky71@aliyun.com | 邮政地址 Postal address | 湖北省-武汉市-江汉路解放大道1277号 Hubei Province - Wuhan City - Jianghan Road Jiefang Avenue No. 1277 | ||
邮编 Zip | 430022 | 单位名称 The name of the organization | 华中科技大学同济医学院附属协和医院 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology |
2、各参加机构信息 2. Information of each participating institution
序号 serial number | 机构名称 Name of the institution | 主要研究者 Principal Investigator | 国家或地区 Country | 省(州) Province (State) | 城市 city |
---|---|---|---|---|---|
1 | 华中科技大学同济医学院附属协和医院 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | 杨坤禹 Yang Kunyu | 中国 China | 湖北省 Hubei Province | 武汉市 Wuhan |
2 | 湖南省肿瘤医院 Hunan Provincial Cancer Hospital | 韩亚骞 Han Yaqian | 中国 China | 湖南省 Hunan Province | 长沙市 Changsha city |
3 | 福建省肿瘤医院 Fujian Provincial Cancer Hospital | 林少俊 Lin Shaojun | 中国 China | 福建省 Fujian Province | 福州市 Fuzhou City |
4 | 浙江大学医学院附属邵逸夫医院 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | 孙晓南 Sun Xiaonan | 中国 China | 浙江省 Zhejiang Province | 杭州市 Hangzhou City |
5 | 浙江省肿瘤医院 Zhejiang Provincial Cancer Hospital | 陈晓钟 Chen Xiaozhong | 中国 China | 浙江省 Zhejiang Province | 杭州市 Hangzhou City |
6 | 苏北人民医院 Subei People's Hospital | 汪步海 Wang Buhai | 中国 China | 江苏省 Jiangsu Province | 扬州市 Yangzhou City |
7 | 四川大学华西医院 West China Hospital, Sichuan University | 刘磊 Liu Lei | 中国 China | 四川省 Sichuan Province | 成都市 Chengdu City |
8 | 山东省肿瘤医院 Shandong Provincial Cancer Hospital | 胡漫 Hu Man | 中国 China | 山东省 Shandong Province | 济南市 Jinan city |
9 | 重庆大学附属肿瘤医院 Affiliated Cancer Hospital of Chongqing University | 谢悦 Xie Yue | 中国 China | 重庆市 Chongqing Municipality | 重庆市 Chongqing Municipality |
10 | 江西省肿瘤医院 Jiangxi Provincial Cancer Hospital | 李金高 Li Jingao | 中国 China | 江西省 Jiangxi Province | 南昌市 Nanchang city |
11 | 四川省肿瘤医院 Sichuan Provincial Cancer Hospital | 冯梅 Feng Mei | 中国 China | 四川省 Sichuan Province | 成都市 Chengdu City |
12 | 吉林大学第一医院 The First Hospital of Jilin University | 姜新 Jiang Xin | 中国 China | 吉林省 Jilin Province | 长春市 Changchun city |
13 | 广西壮族自治区肿瘤医院 (广西医科大学附属肿瘤医院) Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University) |
曲颂 Song Song | 中国 China | 广西壮族自治区 Guangxi Zhuang Autonomous Region | 南宁市 Nanning |
14 | 天津市肿瘤医院 Tianjin Cancer Hospital | 王佩国 Wang Peiguo | 中国 China | 天津市 Tianjin City | 天津市 Tianjin City |
15 | 复旦大学附属肿瘤医院 Fudan University Cancer Hospital | 胡超苏 Hu Chaosu | 中国 China | 上海市 Shanghai | 上海市 Shanghai |
16 | Instituto de Oncologia Angel Roffo | Giglio, Raul Eduardo | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
17 | Centro Oncologico Riojano Integral (CORI) | Kaen, Diego Lucas | Argentina | La Rioja | La Rioja |
18 | Clinica Viedma S.A. | Kowalyszyn, Ruben | Argentina | Rio Negro | Viedma |
19 | CEMAIC - Centro Medico Privado | Salinas, Jorge Emilio | Argentina | Cordoba | Cordoba |
20 | Fundacion Scherbovsky | Sola, Alejandro | Argentina | Mendoza | Mendoza |
21 | Krankenhaus der barmherzigen Schwestern Linz | Burian, Martin | Austria | NA | Linz |
22 | LKH - Universitatsklinikum der PMU Salzburg | Greil, Richard | Austria | NA | Salzburg |
23 | LKH - Universitatsklinikum Graz | Thurnher, Dietmar | Austria | NA | Graz |
24 | Cliniques Universitaires Saint-Luc | Machiels, Jean-Pascal | Belgium | NA | Bruxelles |
25 | UZA | Rasschaert, Marika | Belgium | NA | Namur |
26 | Oncosite - Centro de Pesquisa Clinica e Oncologia | Andre Franke, Fabio | Brazil | Rio Grande do Sul | Ijui |
27 | Irmandade da Santa Casa de Misericordia de Porto Alegre | Arima Tiscoski, Katsuki | Brazil | Rio Grande do Sul | Porto Alegre |
28 | HGB - Hospital Giovanni Battista - Mae de Deus Center HGB - Hospital Giovanni Battista - Mother of God Center |
Arrieira Azambuja, Alan | Brazil | Rio Grande do Sul | Porto Alegre |
29 | Hospital de Cancer de Barretos - Fundacao Pio XII Barretos Cancer Hospital - Pius XII Foundation |
Baston Silva, Carlos | Brazil | Sao Paulo | Barretos |
30 | INCA - Instituto Nacional de Cancer | Dutra, Jamille | Brazil | Rio do Janeiro | Rio do Janeiro |
31 | Hospital de Clínicas de Porto Alegre | Jobim de Azevedo, Sergio | Brazil | Rio Grande do Sul | Porto Alegre |
32 | Instituto de Cancer de Londrina | Menacho de Oliveira, Rivadavio Antunes | Brazil | Parana | Londrina |
33 | Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer Erasto Gaertner Hospital - Paranaense League for the Fight against Cancer |
Martinelli de Oliveira, Fabrício Augusto | Brazil | Martinelli de Oliveira, Fabrício Augusto | Curitiba |
34 | Grupo Oncoclínicas | Martins De Marchi, Pedro Rafael | Brazil | Rio do Janeiro | Rio do Janeiro |
35 | ICESP - Instituto do Cancer do Estado de S?o Paulo Octavio Frias de Oliveira ICESP - Cancer Institute of the State of São Paulo Octavio Frias de Oliveira |
Perez Mak, Milena | Brazil | Sao Paulo | Sao Paulo |
36 | CRIO - Centro Regional Integrado de Oncologia | Pinto Figueiredo Lima, Iane | Brazil | Ceará | Fortaleza |
37 | CEPON - Centro de Pesquisas Oncológicas de Santa Catarina | Pontes Grando, Fabricio | Brazil | Santa Catarina | Florianópolis |
38 | Liga Norte-Rio-Grandense Contra o Cancer | Sales, Silvio | Brazil | Rio Grande do Norte | Natal |
39 | CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia CEPHO - Center for Studies and Research in Hematology and Oncology |
Vaz de Melo Sette, Claudia | Brazil | Sao Paulo | Santo Andre |
40 | Hospital Beneficencia Portuguesa de Sao Paulo | Vieira dos Santos, Lucas | Brazil | Vieira dos Santos, Lucas | Sao Paulo |
41 | Fakultni nemocnice Bulovka | Holeckova, Petra | Czech Republic | NA | Praha |
42 | Fakultni nemocnice Olomouc | Melichar, Bohuslav | Czech Republic | NA | Olomouc |
43 | Hopital Prive Drome Ardeche | Bosset, Matthieu | France | Ardeche | Guilherand Granges |
44 | CHU Tours - Hopital Bretonneau | Chapet, Sophie | France | Indre et Loire | Tours cedex |
45 | CHU Bordeaux | Daste, Amaury | France | Gironde | Bordeaux cedex |
46 | Hopital Tenon | Huguet, Florence | France | Paris | Paris |
47 | Centre Azureen Cancerologie | Lenglet, Alexis | France | Alpes Maritimes | Mougins |
48 | Centre Oscar Lambret | Liem, Xavier | France | Nord | Lille cedex |
49 | ICO - Site René Gauducheau | Rolland, Frederic | France | Loire Atlantique | Saint Herblain |
50 | Hopital de la Timone | Salas, Sebastien | France | Bouches-du-Rh?ne Bouches-du-Rh? ne | Marseille Cedex 5 |
51 | CHU Brest - Hopital Morvan | Schick, Ulrike | France | Finistere | Brest Cedex |
52 | Institut Gustave Roussy | Tao, Yungan | France | Val de Marne | Villejuif cedex |
53 | CHI Toulon La Seyne - Hopital Sainte Musse | Tchiknavorian, Xavier | France | Var | Toulon cedex |
54 | Centre Henri Becquerel | Thureau, Sebastien | France | Seine Maritime | Rouen |
55 | Centre Georges Francois Leclerc | Vulquin, Noemie | France | Cote-d'Or | Dijon Cedex |
56 | Universitaetsklinikum Schleswig-Holstein - Campus Kiel University Medical Center Schleswig-Holstein - Campus Kiel |
Domschikowski, Justus | Germany | Schleswig Holstein | Kiel |
57 | Universitaetsklinikum Jena | Guntinas-Lichius, Orlando | Germany | Thueringen | Jena |
58 | Universitaetsmedizin Rostock | Hildebrandt, Guido | Germany | Mecklenburg Vorpommern | Rostock |
59 | Universitaetsklinikum Leipzig | Kuhnt, Thomas | Germany | Bayern | Regensburg |
60 | Universitaetsklinikum Giessen und Marburg GmbH | Langer, Christine | Germany | Hessen | Marburg |
61 | Vivantes Klinikum Neukoelln | de Wit, Maike | Germany | Berlin | Berlin |
62 | Caritasklinik St. Theresia | Topaly, Julian | Germany | Saarland | Saarbruecken |
63 | Tata Medical Centre | Chatterjee, Sanjoy | India | West Bengal | Kolkata |
64 | Regional Cancer Centre | Kumar, Rejnish | India | Kerala | Thiruvananthapuram |
65 | National Cancer Institute Nagpur | Pathak, Anand | India | Maharashtra | Nagpur |
66 | Chaim Sheba Medical Center | Gluck, Iris | Israel | NA | Ramat Gan |
67 | Soroka University Medical Center | Meirovitz, Amichay | Israel | NA | Beer sheva |
68 | Hadassah University Hospital - Ein Kerem | Popovtzer, Aron | Israel | NA | Yerushalayim |
69 | Rambam Health Care Center | Salman, Saeed | Israel | NA | Haifa |
70 | University of Pittsburgh Medical Center Health System | Ferris, Robert | United States | Pennsylvania | Pittsburgh |
71 | Montefiore Medical Center Radiology | Kabarriti, Rafi | United States | New York | Bronx |
72 | Greenville Hospital System University Medical Center (ITOR) | O'Neal, Richard | United States | South Carolina | Greenville |
73 | Barbara Ann Karmanos Cancer Institute | Sukari, Ammar | United States | Michigan | Detroit |
74 | University of Cincinnati Cancer Institute | Medek, Sara | United States | Ohio | Cincinnati |
75 | Dana-Farber Cancer Institute | Haddad, Robert | United States | Massachusetts | Boston |
76 | University of Alabama at Birmingham | Bonner, James | United States | Alabama | Birmingham |
77 | Perlmutter Cancer Center at NYU Langone Hospital ae Long Island | Li, Zujun | United States | New York | New York |
78 | CHUM Centre de Recherche | Soulieres, Denis | Canada | Quebec | Montreal |
79 | Centro de Atencion e Investigacion Clinica en Oncologia | Molina Alavez, Alejandro | Mexico | Yucatan | Merida |
80 | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Ramirez Godinez, Francisco Javier | Mexico | Jalisco | Guadalajara |
81 | Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González |
Oyervides Juarez, Victor Manuel | Mexico | Nuevo Leon | Monterrey |
82 | Hospital Santa Izabel - Santa Casa de Misericordia da Bahia | Brito, Daniel | Brazil | Bahia | Salvador |
83 | Yokohama City University Hospital | Oridate, Nobuhiko | Japan | Kanagawa-Ken | Yokohama-shi |
84 | NHO Hokkaido Cancer Center | Ueda, Michihiro | Japan | Hokkaido | Sapporo-shi |
85 | Osaka International Cancer Institute | Fujii, Takashi | Japan | Osaka-Fu | Osaka-shi |
86 | Cancer Institute Hospital of JFCR | Tomomatsu, Junichi | Japan | Tokyo-To | Koto-ku |
87 | Aichi Cancer Center Hospital | Hanai, Nobuhiro | Japan | Aichi-Ken | Nagoya-shi |
88 | Kindai University Hospital | Tanaka, Kaoru | Japan | Osaka-Fu | Osakasayama-shi |
89 | Hiroshima University Hospital | Ueda, Tsutomu | Japan | Hiroshima-Ken | Hiroshima-shi |
90 | National Cancer Center Hospital | Murakami, Naoya | Japan | Tokyo-To | Chuo-ku |
91 | Okayama University Hospital | Ando, Mizuo | Japan | Okayama-Ken | Okayama-shi |
92 | National Cancer Center Hospital East | Tahara, Makoto | Japan | Chiba-Ken | Kashiwa-shi |
93 | Nagoya University Hospital | Nishio, Naoki | Japan | Aichi-Ken | Nagoya-shi |
94 | Kobe University Hospital | Kiyota, Naomi | Japan | Hyogo-Ken | Kobe-shi |
95 | Tohoku University Hospital | Katori, Yukio | Japan | Miyagi-Ken | Sendai-shi |
96 | Saitama Cancer Center | Shirakura, Satoshi | Japan | Saitama-Ken | Kitaadachi-gun |
97 | Kagawa University Hospital | Okita, Yoshihiro | Japan | Kagawa-Ken | Kita-gun |
98 | Pusan National University Yangsan Hospital | Oh, So Yeon | Korea, Republic of | Gyeongsangnam-do | Yangsan-si |
99 | Seoul National University Bundang Hospital | Kim, Ji-Won | Korea, Republic of | Gyeonggi-do | Seongnam |
100 | Severance Hospital, Yonsei University Health System | Kim, Hye Ryun | Korea, Republic of | NA | Seoul |
101 | Chonnam National University Hwasun Hospital | Shim, Hyun Jeong | Korea, Republic of | Jeollanam-do | Hwasun-gun |
102 | Seoul National University Hospital | Keam, Bhumsuk | Korea, Republic of | NA | Seoul |
103 | Konkuk University Medical Center | Park, Ji-Hyun | Korea, Republic of | NA | Seoul |
104 | The Catholic University of Korea, St. Vincent's Hospital | An, Ho Jung | Korea, Republic of | Gyeonggi-do | Suwon-si |
105 | Korea University Anam Hospital | Shin, Sang-Won | Korea, Republic of | NA | Seoul |
106 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Wang, Hui-Ching | 中国台湾 Taiwan, China | NA | Kaohsiung |
107 | National Taiwan University Hospital | Lou, Pei-Jen | 中国台湾 Taiwan, China | NA | Taipei |
108 | National Cheng Kung University Hospital | Wu, Shang-Yin | 中国台湾 Taiwan, China | NA | Tainan |
109 | Kaohsiung Chang Gung Memorial Hospital | Chiu, Tai-Jan | 中国台湾 Taiwan, China | NA | Kaohsiung |
110 | Chi Mei Hospital, Liouying | Lin, Chien-Liang | 中国台湾 Taiwan, China | NA | Tainan |
111 | Chang Gung Memorial Hospital,Linkou | Chang, Tung-Chieh | 中国台湾 Taiwan, China | NA | Taoyuan County |
112 | Taipei Veterans General Hospital | Yang, Muh-Hwa | 中国台湾 Taiwan, China | NA | Taipei City |
113 | China Medical University Hospital | Lien, Ming-Yu | 中国台湾 Taiwan, China | NA | Taichung |
114 | Changhua Christian Medical Foundation Changhua Christian Hospital | Lin, Jin-Ching | 中国台湾 Taiwan, China | NA | Changhua |
115 | Tata Memorial Hospital | Noronha, Vanita | India | Maharashtra | Mumbai |
116 | All India Institute of Medical Sciences | Sharma, Atul | India | Delhi | New Delhi |
117 | KABEG-Klinikum Klagenfurt | Eckel, Hans Edmund | Austria | NA | Klagenfurt am Worthersee |
118 | Vitaz | Lybaert, Willem | Belgium | NA | Sint Niklaas |
119 | Fakultni nemocnice Kralovske Vinohrady | Lickova, Katerina | Czech Republic | NA | Praha 10 |
120 | Clinique Victor Hugo - Centre Jean Bernard | Pointreau, Yoann | France | Sarthe | Le Mans Cedex 02 |
121 | Centre Hospitalier Prive Saint-Gregoire (Rennes) | Riet, Francois Georges | France | Ille et Vilaine | Saint Gregoire |
122 | Institut Regional du Cancer de Montpellier | Boisselier, Pierre | France | Herault | Montpellier |
123 | ICO - Site Paul Papin | Goineau, Aurore | France | Maine et Loire | Angers Cedex 2 |
124 | Centre Hospitalier de la Croix Rousse | Lapierre, Ariane | France | Rhone | Criox-Rousse |
125 | Centre Antoine Lacassagne | Saada-Bouzid, Esma | France | Alpes Maritimes | Nice |
126 | CHU Poitiers - Hopital la Miletrie | Evrard, Camille | France | Vienne | Poitiers |
127 | Institut Claudius Regaud | Modesto, Anouchka | France | Haute Garonne | Toulouse cedex 09 |
128 | Institut de Cancerologie de Strasbourg Europe - ICANS | Borel, Christian | France | Bas Rhin | Strasbourg |
129 | Centre Hospitalier de Bretagne Sud | Sire, Christian | France | Morbihan | Lorient cedex |
130 | High Technology Medical Center, University Clinic | Gogishvili, Miranda | Georgia | NA | Tbilisi |
131 | New Hospitals | Giorgadze, Davit | Georgia | NA | Tbilisi |
132 | Interbalkan Hospital of Thessaloniki | Baka, Sofia | Greece | NA | Thessaloniki |
133 | University General Hospital | Psyrri, Amanda | Greece | NA | Athens |
134 | General Hospital of Athens of Chest Diseases | Syrigos, Konstantinos | Greece | NA | Athens |
135 | A.O.U. Policlinico di Modena | Bertolini, Federica | Italy | Modena | Modena |
136 | Azienda Ospedaliera Universitaria Careggi | Livi, Lorenzo | Italy | Firenze | Firenze |
137 | IEO Istituto Europeo di Oncologia | Nole, Franco | Italy | Milano | Milano |
138 | Fondazione del Piemonte per l'Oncologia IRCC Candiolo Piedmont Foundation for Oncology IRCC Candiolo |
Galizia, Danilo | Italy | Torino | Candiolo |
139 | Ospedale San Raffaele | Mirabile, Aurora | Italy | Milano | Milano |
140 | IOV - Istituto Oncologico Veneto IRCCS | Ghi, Mariagrazia | Italy | Padova | Padova |
141 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Agostino Gemelli University Hospital Foundation IRCCS |
Valentini, Vincenzo | Italy | Roma | Roma |
142 | Fondazione IRCCS Istituto Nazionale dei Tumori | Licitra, Lisa | Italy | Milano | Milano |
143 | Ospedale Oncologico Armando Businco | Ghiani, Massimo | Italy | Cagliari | Cagliari |
144 | IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori IRCCS Romagna Scientific Institute for the Study and Treatment of Tumors |
De Rosa, Francesco | Italy | Forli - Cesena | Meldola |
145 | Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza Azienda Ospedaliera Universitaria Policlinico Umberto I - University of Rome La Sapienza |
Botticelli, Andrea | Italy | Roma | Roma |
146 | Azienda Ospedaliera Universitaria- Universita degli Studi della Campania “Luigi Vanvitelli” University Hospital - University of Campania "Luigi Vanvitelli" |
Fasano, Morena | Italy | Napoli | Napoli |
147 | Istituto Nazionale Tumori Fondazione G. Pascale | Perri, Francesco | Italy | Napoli | Napoli |
148 | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Buglione, Michela | Italy | Brescia | Brescia |
149 | UMC Utrecht | De Ridder, Mischa | Netherlands | NA | Utrecht |
150 | Universitair Medisch Centrum Groningen | Oosting, Sjoukje | Netherlands | NA | Groningen |
151 | Amsterdam UMC, Locatie VUMC | Buter, Jan | Netherlands | NA | Amsterdam |
152 | Centrum Onkologii-Instytut im.M.Sklodowskiej Curie Oncology Centre-Institute of M. Skłodowska-Curie |
Rutkowski, Tomasz | Poland | NA | Gliwice |
153 | Hospital de Braga | Ferreira Pereira, Filipa Margarida | Portugal | NA | Braga |
154 | Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE | Vieira, Claudia | Portugal | NA | Porto |
155 | Centro Hospitalar de Sao Joao, E.P.E | Coelho, Andreia | Portugal | NA | Porto |
156 | Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E. | Monteiro, Ana | Portugal | NA | Vila Nova de Gaia |
157 | S.C Medisprof S.R.L | Udrea, Anghel Adrian | Romania | NA | Cluj-Napoca |
158 | S.C Radiotherapy Center Cluj S.R.L | Ungureanu, Andrei | Romania | NA | Comuna Floresti |
159 | S.C Oncocenter Oncologie Clinica S.R.L | Scheusan, Roxana-Ioana | Romania | NA | Timisoara |
160 | S.C Centrul de Oncologie Sf. Nectarie S.R.L | Schenker, Michael | Romania | NA | Craiova |
161 | Centrul medical Focus | Iordan, Ingrid | Romania | NA | Bucuresti |
162 | Hospital Universitario Virgen del Rocio | Flor Oncala, Maria Jose | Spain | Sevilla | Sevilla |
163 | Clinica Universidad de Navarra (MAD) | Serrano, Javier | Spain | Madrid | Madrid |
164 | Hospital Regional Universitario de Malaga | Rueda Dominguez, Antonio | Spain | Malaga | Malaga |
165 | Hospital Universitario Fundacion Jimenez Diaz | Rubio Perez, Jaime | Spain | Madrid | Madrid |
166 | Hospital Universitario Lucus Augusti | Hospital Universitario Lucus Augusti | Spain | Lugo | Lugo |
167 | Complejo Hospitalario Universitario Insular Materno-Infantil | Gomez de Liano Lista, Alfonso | Spain | Las Palmas | Las Palmas de Gran Canaria |
168 | Hospital del Mar | Corbera, Alex | Spain | Barcelona | Barcelona |
169 | ICO l'Hospitalet - Hospital Duran i Reynals | Oliva Bernal, Marc | Spain | Barcelona | L'Hospitalet de Llobregat |
170 | Hospital Universitari Vall d'Hebron | Giralt Lopez de Sagredo, Jordi | Spain | Barcelona | Barcelona |
171 | ICO Badalona - Hospital Universitari Germans Trias i Pujol | Ferrando, Angelica | Spain | Barcelona | Barcelona |
172 | Complejo Hospitalario Universitario A Coruna | Molina, Aurea | Spain | La Coruna | A Coruna |
173 | Hospital Universitario La Paz | Castelo Fernandez, Beatriz | Spain | Madrid | Madrid |
174 | Hospital Clinic de Barcelona | Baste Rotllan, Neus | Spain | Barcelona | Barcelona |
175 | Universitaetsspital Basel | Bunea, Andrei | Switzerland | NA | Basel |
176 | CHUV, Lausanne University Hospital | Cristina, Valérie | Switzerland | NA | Lausanne |
177 | Universitaetsspital Zuerich | Balermpas, Panagiotis | Switzerland | NA | Zuerich |
178 | Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) Institute of Oncology of Southern Switzerland (IOSI) - Ente Ospedaliero Cantonale (EOC) |
Espeli, Vittoria | Switzerland | NA | Bellinzona |
179 | Inonu Uni. Med. Fac. | Harputluoglu, Hakan | Turkey | NA | Malatya |
180 | Gazi University Medical Faculty | Yazici, Ozan | Turkey | NA | Ankara |
181 | Trakya University Medical Faculty | Hacioglu, Bekir | Turkey | NA | Edirne |
182 | Adana City Hospital | Cil, Timucin | Turkey | NA | Adana |
183 | Izmir Medicalpark Hospital | Arslan, Cagatay | Turkey | NA | Izmir |
184 | Medipol University Medical Faculty | Bilici, Ahmet | Turkey | NA | Istanbul |
185 | Mount Vernon Hospital | Chiu, Kevin | United Kingdom | Middlesex | Middlesex |
186 | Royal Surrey County Hospital | Mehta, Ajay | United Kingdom | Surrey | Guildford |
187 | Clatterbridge Cancer Centre | Clatterbridge Cancer Centre | United Kingdom | Merseyside | Wirral |
188 | St James's University Hospital | Sen, Mehmet | United Kingdom | West Yorkshire | Leeds |
189 | Western General Hospital | Western General Hospital | United Kingdom | Lothian Region | Edinburgh |
190 | The Christie Hospital | Hughes, Christopher | United Kingdom | Greater Manchester | Greater Manchester |
191 | 中南大学湘雅医院 Xiangya Hospital, Central South University | 申良方 Shen Liangfang | 中国 China | 湖南省 Hunan Province | 长沙市 Changsha city |
192 | 北京肿瘤医院 Beijing Cancer Hospital | 孙艳 Sun Yan | 中国 China | 北京市 Beijing | 北京市 Beijing |
193 | 上海市第一人民医院 Shanghai First People's Hospital | 董频 Dong Pin | 中国 China | 上海市 Shanghai | 上海市 Shanghai |
194 | 河南省肿瘤医院 Henan Provincial Cancer Hospital | 吴慧 Wu Hui | 中国 China | 河南省 Henan Province | 郑州市 Zhengzhou City |
195 | 安徽省肿瘤医院 Anhui Provincial Cancer Hospital | 高劲 Gao Jin | 中国 China | 安徽省 Anhui Province | 合肥市 Hefei City |
196 | 中山大学肿瘤防治中心 (中山大学附属肿瘤医院) Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital) | 吴少雄 Wu Shaoxiong | 中国 China | 广东省 Guangdong Province | 广州市 Guangzhou City |
197 | 南京鼓楼医院 Nanjing Drum Tower Hospital | 闫婧 Yan Jing | 中国 China | 江苏省 Jiangsu Province | 南京市 Nanjing |
198 | 中国医科大学附属盛京医院 Shengjing Hospital Affiliated to China Medical University | 刘彩刚 Liu Caigang | 中国 China | 辽宁省 Liaoning Province | 沈阳市 Shenyang city |
199 | 蚌埠医学院第一附属医院 The First Affiliated Hospital of Bengbu Medical College | 张亚军 Zhang Yajun | 中国 China | 安徽省 Anhui Province | 蚌埠市 Bengbu City |
200 | 西安交大附属二院 The Second Affiliated Hospital of Xi'an Jiaotong University | 马红兵 Ma Hongbing | 中国 China | 陕西省 Shaanxi Province | 西安市 Xi'an City |
201 | Institut Jules Bordet | Awada, Ahmad | Belgium | NA | Anderlecht |
202 | High Technology Hospital Medcenter LLC | Makharadze, Tamta | Georgia | NA | Batumi |
203 | Evex Hospitals Oncology Center | Natelauri, Eter | Georgia | NA | Kutaisi |
204 | Cancer Research Center Ltd. | Matitashvili, Amiran | Georgia | NA | Tbilisi |
205 | Musgrove Park Hospital | Jankowska, Petra | United Kingdom | Somerset | Taunton |
206 | Royal Marsden Hospital- London | Harrington, Kevin | United Kingdom | Greater London | London |
五、伦理委员会信息 V. Information on the Ethics Committee
序号 serial number | 名称 name | 审查结论 Conclusions of the review | 批准日期/备案日期 Approval Date/Filing Date |
---|---|---|---|
1 | 华中科技大学同济医学院附属协和医院医学伦理委员会 Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology |
同意 agree | 2022-08-02 |
2 | 华中科技大学同济医学院附属协和医院医学伦理委员会 Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology |
同意 agree | 2023-02-27 |
3 | 华中科技大学同济医学院附属协和医院医学伦理委员会 Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology |
同意 agree | 2023-12-06 |
六、试验状态信息 6. Test status information
1、试验状态 1. Test status
进行中
(招募中)
Ongoing (Recruiting)2、试验人数 2. The number of experiments
目标入组人数 Target enrollment | 国内: 83 ; 国际: 700 ; Domestic: 83 ; International: 700 ; |
---|---|
已入组人数 Number of people enrolled | 国内: 19 ; 国际: 89 ; Domestic: 19 ; International: 89 ; |
实际入组总人数 The total number of people actually enrolled |
国内: 登记人暂未填写该信息;
国际: 登记人暂未填写该信息;
Domestic: The registrant has not filled in this information yet; International: The registrant has not filled in this information yet; |
3、受试者招募及试验完成日期 3. Subject recruitment and the date of completion of the trial
第一例受试者签署知情同意书日期 The date on which the first subject signed the informed consent form |
国内:2022-10-06;
国际:2023-01-16;
Domestic:2022-10-06; International:2023-01-16; |
---|---|
第一例受试者入组日期 Date of enrollment of the first subject |
国内:2022-10-21;
国际:2023-02-12;
Domestic:2022-10-21; International: 2023-02-12; |
试验完成日期 The date of completion of the experiment |
国内:登记人暂未填写该信息;
国际:登记人暂未填写该信息;
Domestic: The registrant has not filled in this information yet; International: The registrant has not yet filled in this information; |
七、临床试验结果摘要 7. Summary of clinical trial results
序号 serial number | 版本号 Version number | 版本日期 Version date |
---|---|---|
暂未填写此信息 This information is not filled in yet |