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一项比较 Sacituzumab Tirumotecan (MK-2870) 单药治疗与医生选择的治疗作为复发或转移性宫颈癌参与者二线治疗的研究 (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

2026年8月27日更新者：Merck Sharp & Dohme LLC

一项 3 期随机、活性对照、开放标签、多中心研究，比较 MK-2870 单药疗法与医生选择的治疗作为复发性或转移性宫颈癌参与者的二线治疗的疗效和安全性 (TroFuse-020/GOG -3101/ENGOT-cx20)

该研究将分为两个阶段：sacituzumab tirumotecan 安全磨合阶段和第 3 阶段部分。安全磨合阶段将用于评估 sacituzumab tirumotecan 在第 3 期部分评估剂量下的疗效和安全性。本研究的目的是比较 sacituzumab tirumotecan 与医生选择的治疗作为二线治疗对 3 期部分的复发性或转移性宫颈癌参与者的疗效和安全性。

主要研究假设是，在第 3 阶段部分，与 TPC 相比，在滋养层细胞表面抗原 2 (TROP2) 高表达水平的参与者和所有参与者中，sacituzumab tirumotecan 都能带来更好的总体生存率。

研究概览

地位

主动，不招人

条件

宫颈癌

干预/治疗

研究类型

介入性

注册 (估计的)

686

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- Anhui
  - Hefei、Anhui、中国、230000
    - Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
  - Hefei、Anhui、中国、230071
    - Anhui Provincial Hospital ( Site 5011)
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100730
    - Beijing Peking Union Medical College Hospital ( Site 5045)
- Chongqing Municipality
  - Chongqing、Chongqing Municipality、中国、400030
    - Chongqing University Cancer Hospital ( Site 5003)
- Fujian
  - Fuzhou、Fujian、中国、350014
    - Fujian Provincial Cancer Hospial ( Site 5012)
  - Xiamen、Fujian、中国、361003
    - The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
- Guangdong
  - Guangzhou、Guangdong、中国、510000
    - Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
  - Guangzhou、Guangdong、中国、511400
    - Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
  - Zhanjiang、Guangdong、中国、524004
    - Affiliated Hospital of Guangdong Medical University ( Site 5004)
- Guangxi
  - Nanning、Guangxi、中国、530200
    - Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
- Hainan
  - Haikou、Hainan、中国、570311
    - Hainan General Hospital ( Site 5032)
- Heilongjiang
  - Harbin、Heilongjiang、中国、150000
    - Harbin Medical University Cancer Hospital ( Site 5010)
- Henan
  - Xinxiang、Henan、中国、453100
    - The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
  - Zhengzhou、Henan、中国、450008
    - Henan Cancer Hospital ( Site 5026)
- Hubei
  - Wuhan、Hubei、中国、430048
    - Wuhan Union Hospital ( Site 5020)
  - Wuhan、Hubei、中国、430079
    - Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
- Hunan
  - Changsha、Hunan、中国、410013
    - Hunan Cancer Hospital ( Site 5021)
  - Changsha、Hunan、中国、410028
    - Xiangya Hospital Central South University ( Site 5009)
- Jiangsu
  - Nanjing、Jiangsu、中国、210036
    - Jiangsu Province Hospital-Oncology Department ( Site 5018)
- Jiangxi
  - Nanchang、Jiangxi、中国、330077
    - Jiangxi Maternal and Child Health Hospital ( Site 5031)
- Jilin
  - Changchun、Jilin、中国、130000
    - Jilin Province Tumor Hospital ( Site 5036)
- Shaanxi
  - Xi'an、Shaanxi、中国、710061
    - The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
- Shandong
  - Jinan、Shandong、中国、250117
    - Shandong Cancer Hospital ( Site 5014)
  - Linyi、Shandong、中国、276000
    - LinYi Cancer Hospital-Gastrology department ( Site 5039)
- Shanghai Municipality
  - Shanghai、Shanghai Municipality、中国、200011
    - Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
- Shanxi
  - Taiyuan、Shanxi、中国、030000
    - Shanxi Cancer Hospital ( Site 5043)
- Sichuan
  - Chengdu、Sichuan、中国、610000
    - West China Second University Hospital, Sichuan University ( Site 5017)
  - Chengdu、Sichuan、中国、610042
    - Sichuan Cancer hospital-Oncology ( Site 5030)
- Yunnan
  - Kunming、Yunnan、中国、650107
    - Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
- Zhejiang
  - Hangzhou、Zhejiang、中国、310006
    - Women s Hospital School of Medicine Zhejiang University ( Site 5022)
  - Hangzhou、Zhejiang、中国、310022
    - Zhejiang Cancer Hospital ( Site 5008)
  - Wenzhou、Zhejiang、中国、325015
    - The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
丹麦
- Capital Region
  - Copenhagen、Capital Region、丹麦、2100
    - Rigshospitalet-Dept. of Oncology ( Site 1300)
- Central Jutland
  - Aarhus、Central Jutland、丹麦、8200
    - Aarhus Universitetshospital, Skejby ( Site 1301)
- Region Syddanmark
  - Odense C、Region Syddanmark、丹麦、5000
    - Odense Universitetshospital-Department of oncology ( Site 1302)
以色列
- - Haifa、以色列、3109601
    - Rambam Health Care Campus ( Site 2002)
  - Holon、以色列、5810001
    - Edith Wolfson Medical Center ( Site 2003)
  - Jerusalem、以色列、9112001
    - Hadassah Medical Center ( Site 2000)
  - Ramat Gan、以色列、5265601
    - Sheba Medical Center ( Site 2001)
保加利亚
- - Pleven、保加利亚、5804
    - MHAT - Heart and Brain ( Site 1100)
  - Plovdiv、保加利亚、4004
    - Complex Oncology Center - Plovdiv EOOD ( Site 1102)
- Pazardzhik
  - Panagyurishte、Pazardzhik、保加利亚、4500
    - MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
加拿大
- British Columbia
  - Kelowna、British Columbia、加拿大、V1Y 5L3
    - BC Cancer Kelowna ( Site 4007)
  - Surrey、British Columbia、加拿大、V3V 1Z2
    - BC Cancer Surrey ( Site 4006)
  - Victoria、British Columbia、加拿大、V8R 6V5
    - BC Cancer Victoria ( Site 4008)
- Ontario
  - Barrie、Ontario、加拿大、L4M 6M2
    - Royal Victoria Regional Health Centre ( Site 4009)
  - Hamilton、Ontario、加拿大、L8V 5C2
    - Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
- Quebec
  - Montreal、Quebec、加拿大、H2X 0C1
    - Centre Hospitalier de l'Université de Montréal ( Site 4001)
  - Montreal、Quebec、加拿大、H4A 3J1
    - McGill University Health Centre ( Site 4000)
  - Québec、Quebec、加拿大、G1J 1Z4
    - Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
哥伦比亚
- Bogota D.C.
  - Bogotá、Bogota D.C.、哥伦比亚、110131
    - FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
- Cesar Department
  - Valledupar、Cesar Department、哥伦比亚、200001
    - Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
- Cundinamarca
  - Bogota、Cundinamarca、哥伦比亚、111151
    - Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)
- Departamento de Córdoba
  - Montería、Departamento de Córdoba、哥伦比亚、230002
    - IMAT S.A.S ( Site 0402)
- Risaralda Department
  - Pereira、Risaralda Department、哥伦比亚、660001
    - Oncologos del Occidente ( Site 0405)
- Valle del Cauca Department
  - Cali、Valle del Cauca Department、哥伦比亚、760032
    - Fundación Valle del Lili ( Site 0406)
墨西哥
- - Aguascalientes、墨西哥、20124
    - Centro de Investigación Oncológica Galerías SC ( Site 0508)
  - San Luis Potosí City、墨西哥、78200
    - Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0506)
- Mexico City
  - Mexico City、Mexico City、墨西哥、03100
    - CENEIT Oncologicos ( Site 0507)
- Nuevo León
  - San Pedro Garza García、Nuevo León、墨西哥、66220
    - Oncare - Unidad Valle ( Site 0509)
- Oaxaca
  - Oaxaca City、Oaxaca、墨西哥、68020
    - Centro de Investigacion Clinica de Oaxaca ( Site 0505)
奥地利
- - Vienna、奥地利、1090
    - Medizinische Universität Wien ( Site 1001)
- Styria
  - Graz、Styria、奥地利、8036
    - Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
- Tyrol
  - Innsbruck、Tyrol、奥地利、6020
    - Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
- Upper Austria
  - Linz、Upper Austria、奥地利、4020
    - Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
巴西
- - Rio de Janeiro、巴西、22775-001
    - Americas Centro de Oncologia Integrado ( Site 0202)
  - São Paulo、巴西、01321-001
    - Hospital Paulistano ( Site 0209)
- Paraná
  - Curitiba、Paraná、巴西、80510130
    - Instituto do Câncer e Transplante de Curitiba ( Site 0205)
- Rio Grande do Sul
  - Porto Alegre、Rio Grande do Sul、巴西、90035-001
    - Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
  - Porto Alegre、Rio Grande do Sul、巴西、90110-270
    - Hospital do Câncer Mãe de Deus ( Site 0201)
- Santa Catarina
  - Joinville、Santa Catarina、巴西、89202-050
    - Centro de Hematologia e Oncologia ( Site 0203)
- São Paulo
  - São Paulo、São Paulo、巴西、04014-002
    - IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
希腊
- Attica
  - Athens、Attica、希腊、115 28
    - Aretaieio Hospital ( Site 1700)
  - Athens、Attica、希腊、151 23
    - Mitera Hospital ( Site 1702)
  - Chaïdári、Attica、希腊、124 62
    - ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
- Peloponnese
  - Patras、Peloponnese、希腊、263 35
    - Agios Andreas Hospital Patras ( Site 1701)
德国
- - Hamburg、德国、20246
    - Universitaetsklinikum Hamburg-Eppendorf-Department of Gynecology ( Site 1611)
- Baden-Wurttemberg
  - Heidelberg、Baden-Wurttemberg、德国、69120
    - Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen ( Site 1612)
  - Heilbronn、Baden-Wurttemberg、德国、74078
    - SLK-Kliniken Heilbronn ( Site 1617)
  - Schwäbisch Hall、Baden-Wurttemberg、德国、74523
    - Diakonie-Klinikum Schwaebisch-Hall gGmbH Frauenklinik ( Site 1614)
- Bavaria
  - Munich、Bavaria、德国、81377
    - Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 1605)
- Hesse
  - Marburg、Hesse、德国、35043
    - Universitätsklinikum Marburg ( Site 1604)
- North Rhine-Westphalia
  - Düsseldorf、North Rhine-Westphalia、德国、40225
    - Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1607)
  - Essen、North Rhine-Westphalia、德国、45136
    - Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)
  - Essen、North Rhine-Westphalia、德国、45147
    - Universitaetsklinikum Essen ( Site 1613)
- Rhineland-Palatinate
  - Worms、Rhineland-Palatinate、德国、67550
    - Klinikum Worms ( Site 1619)
- Saarland
  - Homburg、Saarland、德国、66421
    - Universitaetsklinikum des Saarlandes ( Site 1618)
意大利
- - Brescia、意大利、25123
    - Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
  - Catania、意大利、95126
    - Ospedale Cannizzaro ( Site 2104)
  - Milan、意大利、20132
    - Ospedale San Raffaele. ( Site 2106)
  - Naples、意大利、80131
    - Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
  - Padova、意大利、35128
    - Istituto Oncologico Veneto IRCCS ( Site 2109)
  - Roma、意大利、00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
- Emilia-Romagna
  - Bologna、Emilia-Romagna、意大利、40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
- Lombardy
  - Milan、Lombardy、意大利、20133
    - Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
  - Milan、Lombardy、意大利、20159
    - Ospedale Humanitas San Pio X ( Site 2113)
  - Milan、Lombardy、意大利、20141
    - Istituto Europeo di Oncologia IRCCS ( Site 2108)
  - Monza、Lombardy、意大利、20900
    - Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
- Milano
  - Rozzano、Milano、意大利、20089
    - Humanitas University ( Site 2112)
- Piedmont
  - Turin、Piedmont、意大利、10128
    - Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
挪威
- - Oslo、挪威、0379
    - Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
新加坡
- Central Singapore
  - Singapore、Central Singapore、新加坡、119228
    - National University Hospital ( Site 3301)
  - Singapore、Central Singapore、新加坡、168583
    - National Cancer Centre Singapore ( Site 3300)
日本
- - Fukuoka、日本、811-1395
    - National Hospital Organization Kyushu Cancer Center ( Site 5104)
  - Kagoshima、日本、890-8760
    - Kagoshima City Hospital ( Site 5115)
  - Niigata、日本、951-8566
    - Niigata Cancer Center Hospital ( Site 5100)
  - Osaka、日本、541-8567
    - Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5103)
- Aichi-ken
  - Nagoya、Aichi-ken、日本、464-8681
    - Aichi Cancer Center ( Site 5110)
- Chiba
  - Kashiwa、Chiba、日本、277-8577
    - National Cancer Center Hospital East ( Site 5113)
- Ehime
  - Matsuyama、Ehime、日本、791-0280
    - National Hospital Organization Shikoku Cancer Center ( Site 5109)
  - Tōon、Ehime、日本、791-0295
    - Ehime University Hospital ( Site 5102)
- Fukuoka
  - Kurume、Fukuoka、日本、830-0011
    - Kurume University Hospital ( Site 5105)
- Gunma
  - Ohta、Gunma、日本、373-8550
    - Gunma Prefectural Cancer Center ( Site 5116)
- Hokkaido
  - Sapporo、Hokkaido、日本、060-8648
    - Hokkaido University Hospital ( Site 5106)
- Ibaraki
  - Tsukuba、Ibaraki、日本、305-8576
    - University of Tsukuba Hospital ( Site 5114)
- Iwate
  - Shiwa-gun、Iwate、日本、028-3695
    - Iwate Medical University Hospital ( Site 5112)
- Saitama
  - Hidaka、Saitama、日本、350-1298
    - Saitama Medical University International Medical Center ( Site 5117)
- Shizuoka
  - Sunto-gun,、Shizuoka、日本、411-8777
    - Shizuoka Cancer Center ( Site 5107)
- Tokyo
  - Chūō、Tokyo、日本、104-0045
    - National Cancer Center Hospital ( Site 5108)
  - Koto、Tokyo、日本、135-8550
    - Cancer Institute Hospital of JFCR ( Site 5111)
  - Minato、Tokyo、日本、105-8471
    - The Jikei University Hospital ( Site 5118)
  - Shinjyuku、Tokyo、日本、160-8582
    - Keio University Hospital ( Site 5101)
智利
- Region M. de Santiago
  - Santiago、Region M. de Santiago、智利、7500921
    - FALP-UIDO ( Site 0300)
  - Santiago、Region M. de Santiago、智利、832000
    - Pontificia Universidad Catolica de Chile ( Site 0302)
- Valparaiso
  - Viña del Mar、Valparaiso、智利、2520598
    - ONCOCENTRO APYS-ACEREY ( Site 0303)
比利时
- - Namur、比利时、5000
    - CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
- Oost-Vlaanderen
  - Aalst、Oost-Vlaanderen、比利时、9300
    - AZORG Campus Aalst-Moorselbaan ( Site 2905)
  - Ghent、Oost-Vlaanderen、比利时、9000
    - UZ Gent-Medical oncology ( Site 2901)
- Vlaams-Brabant
  - Leuven、Vlaams-Brabant、比利时、3000
    - UZ Leuven-Gynecologic Oncology ( Site 2900)
- Wallonne, Region
  - Belgium、Wallonne, Region、比利时、4000
    - Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
法国
- - Paris、法国、75020
    - Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
- Aquitaine
  - Bordeaux、Aquitaine、法国、33076
    - Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
- Auvergne
  - Clermont-Ferrand、Auvergne、法国、63011
    - Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
- Auvergne-Rhône-Alpes
  - Lyon Cedex08、Auvergne-Rhône-Alpes、法国、69373
    - CENTRE LEON BERARD ( Site 1505)
- Bas-Rhin
  - Strasbourg、Bas-Rhin、法国、67098
    - Hopitaux Universitaires de Strasbourg ( Site 1501)
- Bouches-du-Rhone
  - Marseille、Bouches-du-Rhone、法国、13009
    - Institut Paoli-Calmettes ( Site 1504)
- Cotes-d Armor
  - Plérin、Cotes-d Armor、法国、22190
    - Hôpital Privé Des Côtes d'Armor ( Site 1510)
- Franche-Comte
  - Besançon、Franche-Comte、法国、25030
    - CHU Besançon ( Site 1507)
- Haute-Garonne
  - Toulouse、Haute-Garonne、法国、31059
    - Oncopole Claudius Regaud ( Site 1502)
- Herault
  - Montpellier、Herault、法国、34298
    - Institut Regional du Cancer Montpellier ( Site 1511)
- Loire-Atlantique
  - Nantes、Loire-Atlantique、法国、44277
    - Hôpital privé du Confluent SAS ( Site 1509)
- Île-de-France Region
  - Villejuif、Île-de-France Region、法国、94805
    - Gustave Roussy ( Site 1512)
波兰
- Greater Poland Voivodeship
  - Poznan、Greater Poland Voivodeship、波兰、60-569
    - Uniwersytecki Szpital Kliniczny w Poznaniu-Klinika Ginekologii Onkologicznej ( Site 2404)
- Masovian Voivodeship
  - Warsaw、Masovian Voivodeship、波兰、02-781
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
- Podlaskie Voivodeship
  - Bialystok、Podlaskie Voivodeship、波兰、15-027
    - Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
波多黎各
- - San Juan、波多黎各、00935
    - UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
澳大利亚
- New South Wales
  - Sydney、New South Wales、澳大利亚、2148
    - Blacktown Hospital ( Site 3006)
  - Sydney、New South Wales、澳大利亚、2560
    - Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
- Queensland
  - Herston、Queensland、澳大利亚、4029
    - Royal Brisbane and Women's Hospital ( Site 3001)
- Victoria
  - Clayton、Victoria、澳大利亚、3168
    - Monash Health-Oncology Research ( Site 3002)
  - Melbourne、Victoria、澳大利亚、3000
    - Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
- Western Australia
  - Nedlands、Western Australia、澳大利亚、6009
    - Sir Charles Gairdner Hospital ( Site 3003)
爱尔兰
- - Cork、爱尔兰、T12 E8YV
    - Cork University Hospital ( Site 1900)
  - Dublin、爱尔兰、D07 R2WY
    - Mater Misericordiae University Hospital ( Site 1901)
  - Dublin、爱尔兰、D08 E9P6
    - St. James's Hospital-Cancer clinical trials office ( Site 1902)
瑞典
- Skåne County
  - Lund、Skåne County、瑞典、221 85
    - Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
- Stockholm County
  - Stockholm、Stockholm County、瑞典、171 64
    - Karolinska Universitetssjukhuset Solna ( Site 2601)
- Uppsala County
  - Uppsala、Uppsala County、瑞典、751 85
    - Akademiska sjukhuset ( Site 2603)
- Östergötland County
  - Linköping、Östergötland County、瑞典、581 85
    - Universitetssjukhuset i Linköping ( Site 2600)
瑞士
- - Bern、瑞士、3010
    - Inselspital Bern-Oncology ( Site 2700)
- Canton of Basel-City
  - Basel、Canton of Basel-City、瑞士、4031
    - University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
美国
- Alabama
  - Mobile、Alabama、美国、36604
    - USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
- Alaska
  - Anchorage、Alaska、美国、99508
    - Providence Alaska Medical Center ( Site 4137)
- Arizona
  - Phoenix、Arizona、美国、85016
    - HonorHealth (HH) ( Site 8002)
  - Tucson、Arizona、美国、85711
    - Arizona Oncology Associates - HOPE ( Site 8001)
- California
  - La Jolla、California、美国、92093
    - Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
  - Los Angeles、California、美国、90095
    - UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
  - Newport Beach、California、美国、92663
    - Hoag Memorial Hospital Presbyterian ( Site 4104)
- Florida
  - Miami Beach、Florida、美国、33140
    - Mount Sinai Comprehensive Cancer Center ( Site 4143)
  - Orlando、Florida、美国、32804
    - Advent Health ( Site 4140)
  - West Palm Beach、Florida、美国、33401
    - Florida Cancer Specialists East ( Site 7001)
- Georgia
  - Atlanta、Georgia、美国、30342
    - Northside Hospital ( Site 4127)
  - Augusta、Georgia、美国、30912
    - Georgia Cancer Center at Augusta University ( Site 4112)
  - Savannah、Georgia、美国、31405
    - Lewis Cancer and Research Pavilion ( Site 4114)
- Louisiana
  - New Orleans、Louisiana、美国、70112
    - University Medical Center New Orleans ( Site 4132)
  - Shreveport、Louisiana、美国、71103
    - Willis Knighton Medical Center ( Site 4101)
- Nevada
  - Reno、Nevada、美国、89511
    - The Center of Hope ( Site 4106)
- New Jersey
  - Teaneck、New Jersey、美国、07666
    - Holy Name Medical Center ( Site 4117)
- New Mexico
  - Albuquerque、New Mexico、美国、87109
    - Optimum Clinical Research Group ( Site 4138)
- New York
  - Mineola、New York、美国、11501
    - Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)
  - New York、New York、美国、10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)
- North Carolina
  - Durham、North Carolina、美国、27710
    - Duke Cancer Institute ( Site 4120)
- Ohio
  - Cincinnati、Ohio、美国、45219
    - University of Cincinnati Medical Center ( Site 4128)
  - Hilliard、Ohio、美国、43026
    - The Ohio State University ( Site 4103)
- Oklahoma
  - Tulsa、Oklahoma、美国、74146
    - Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
- Oregon
  - Eugene、Oregon、美国、97401
    - Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
  - Portland、Oregon、美国、97210
    - Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19107
    - Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
  - Willow Grove、Pennsylvania、美国、19090
    - Asplundh Cancer Pavilion ( Site 4113)
- Tennessee
  - Germantown、Tennessee、美国、38138
    - The West Clinic, PLLC dba West Cancer Center ( Site 4108)
- Texas
  - Austin、Texas、美国、78731
    - Texas Oncology - Central/South Texas ( Site 8010)
  - Fort Worth、Texas、美国、76104
    - Texas Oncology - DFW ( Site 8003)
  - Houston、Texas、美国、77030
    - Houston Methodist Hospital OB/GYN ( Site 4102)
  - San Antonio、Texas、美国、78240
    - Texas Oncology - San Antonio ( Site 8006)
  - Tyler、Texas、美国、75702
    - Texas Oncology - Northeast Texas ( Site 8009)
  - Webster、Texas、美国、77598
    - Texas Oncology - Gulf Coast ( Site 8008)
- Virginia
  - Charlottesville、Virginia、美国、22908
    - University of Virginia Cancer Center ( Site 4123)
  - Fairfax、Virginia、美国、22031-4867
    - Inova Schar Cancer Institute ( Site 4139)
- Washington
  - Seattle、Washington、美国、98104
    - Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
芬兰
- Pirkanmaa
  - Tampere、Pirkanmaa、芬兰、33520
    - Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
- Southwest Finland
  - Turku、Southwest Finland、芬兰、20520
    - Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
- Uusimaa
  - Helsinki、Uusimaa、芬兰、00029
    - Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
英国
- - Leeds、英国、LS9 7TF
    - St James's University Hospital ( Site 2804)
  - Manchester、英国、m20 4bx
    - The Christie NHS Foundation Trust-Research and Development ( Site 2802)
- England
  - London、England、英国、SW10 9NH
    - ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
  - Sutton、England、英国、SM2 5PT
    - Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
- Glasgow City
  - Glasgow、Glasgow City、英国、G12 0YN
    - Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
- London, City of
  - London、London, City of、英国、NW1 2PG
    - University College London Hospital ( Site 2805)
荷兰
- - Groningen、荷兰、9713 GZ
    - University Medical Center Groningen ( Site 2204)
- Gelderland
  - Nijmegen、Gelderland、荷兰、6525 GA
    - Radboudumc-Medical Oncology ( Site 2202)
- North Brabant
  - Eindhoven、North Brabant、荷兰、5623 EJ
    - Catharina Ziekenhuis-Oncology ( Site 2203)
- North Holland
  - Amsterdam、North Holland、荷兰、1081 HV
    - Amsterdam UMC, locatie VUmc ( Site 2201)
- South Holland
  - Rotterdam、South Holland、荷兰、3015 GD
    - Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
西班牙
- - Barcelona、西班牙、08035
    - Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
  - Córdoba、西班牙、14004
    - Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
  - Madrid、西班牙、28046
    - Hospital Universitario La Paz-Oncología Médica ( Site 2504)
- Catalonia
  - Barcelona、Catalonia、西班牙、08036
    - HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
  - L'Hospitalet de Llobregat、Catalonia、西班牙、08908
    - Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
- Gerona
  - Girona、Gerona、西班牙、17007
    - Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
- Madrid, Comunidad de
  - Madrid、Madrid, Comunidad de、西班牙、28027
    - Clinica Universidad de Navarra ( Site 2510)
  - Madrid、Madrid, Comunidad de、西班牙、28034
    - Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
  - Madrid、Madrid, Comunidad de、西班牙、28041
    - Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
- Valenciana, Comunitat
  - Valencia、Valenciana, Comunitat、西班牙、46009
    - Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
  - Valencia、Valenciana, Comunitat、西班牙、46010
    - HOSPITAL CLINICO DE VALENCIA ( Site 2505)
阿根廷
- - Buenos Aires、阿根廷、C1118AAT
    - Hospital Aleman-Oncology ( Site 0100)
  - CABA、阿根廷、C1431FWO
    - Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
  - La Rioja、阿根廷、F5300COE
    - Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1280AEB
    - Hospital Británico de Buenos Aires-Oncology ( Site 0102)
  - Mar del Plata、Buenos Aires、阿根廷、B7600FZO
    - Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
- Buenos Aires F.D.
  - Buenos Aires、Buenos Aires F.D.、阿根廷、C1417
    - Instituto de Oncología Angel H. Roffo ( Site 0103)
  - Buenos Aires、Buenos Aires F.D.、阿根廷、C1426ANZ
    - Instituto Alexander Fleming ( Site 0108)
- Córdoba Province
  - Córdoba、Córdoba Province、阿根廷、5000
    - Sanatorio Allende - Cerro-Oncology ( Site 0106)
韩国
- - Seoul、韩国、03080
    - Seoul National University Hospital ( Site 3403)
  - Seoul、韩国、03722
    - Severance Hospital, Yonsei University Health System ( Site 3402)
  - Seoul、韩国、05505
    - Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
  - Seoul、韩国、06351
    - Samsung Medical Center ( Site 3400)
马来西亚
- - Kuala Lumpur、马来西亚、59100
    - Pantai Hospital Kuala Lumpur ( Site 3100)
  - Pulau Pinang、马来西亚、10350
    - Penang Adventist Hospital ( Site 3101)
- Kuala Lumpur
  - Lembah Pantai、Kuala Lumpur、马来西亚、59100
    - University Malaya Medical Centre ( Site 3102)
- Selangor
  - Petaling Jaya、Selangor、马来西亚、47500
    - Sunway Medical Centre ( Site 3105)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

纳入标准：

经组织学确诊为鳞状细胞癌、腺鳞癌或宫颈腺癌
患有复发性或转移性宫颈癌
根据研究者评估，实体瘤疗效评估标准 (RECIST) 1.1 具有可测量的疾病。如果位于先前照射区域的病变已显示出进展，则认为该病变是可测量的
出生时性别为女性，提供知情同意书时年满 18 岁
在 Sacituzumab Tirumotecan Run-in 分配前 7 天内或在 3 期部分随机化前 7 天内，ECOG 表现状态为 0 或 1
已提供来自先前未照射过的肿瘤病灶的核心或切除活检的肿瘤组织（最好是最新的样本）
感染 HIV 的参与者必须在抗逆转录病毒治疗 (ART) 中控制好人类免疫缺陷病毒 (HIV)
乙型肝炎表面抗原 (HBsAg) 阳性的参与者如果已接受乙型肝炎病毒 (HBV) 抗病毒治疗至少 4 周，并且在分配（Sacituzumab Tirumotecan Run-in）或随机化之前未检测到 HBV 病毒载量，则符合资格。第三阶段部分）
如果筛查时未检测到丙型肝炎病毒 (HCV) 病毒载量，则有丙型肝炎病毒 (HCV) 感染史的参与者符合资格
具有足够的器官功能

排除标准：

患有≥2级周围神经病变
有严重干眼综合症、严重睑板腺疾病和/或睑缘炎或阻止/延迟角膜愈合的角膜疾病的病史
患有需要免疫抑制药物的活动性炎症性肠病或既往有炎症性肠病病史（例如克罗恩病、溃疡性结肠炎或慢性腹泻）
患有不受控制的严重心血管疾病或脑血管疾病。
既往接受过全身抗癌治疗
研究干预开始后 2 周内接受过放射治疗，或有放射相关毒性，需要皮质类固醇
在第一剂研究干预前 30 天内接种过活疫苗或减毒活疫苗。允许接种灭活疫苗
经组织学确诊为玻璃状细胞癌变异型、腺样囊性癌、腺样基底癌、神经内分泌肿瘤、类癌、非典型类癌、小癌、大细胞神经内分泌癌或未分化癌
过去 3 年内已知正在进展或需要积极治疗的其他恶性肿瘤
已知的活动性中枢神经系统 (CNS) 转移和/或癌性脑膜炎
活动性感染需要全身治疗
有卡波西肉瘤和/或多中心卡斯尔曼病病史的艾滋病毒感染者
同时感染活动性乙型肝炎和活动性丙型肝炎病毒
对 sacituzumab tirumotecan 或医生选择的治疗 (TPC) 和/或其任何赋形剂或其他生物疗法严重过敏（≥3 级）
尚未从大手术中充分恢复或有持续手术并发症的参与者

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：沙妥珠单抗替鲁莫替康参与者将通过静脉 (IV) 输注每两周 (Q2W) 接受一次 4 mg/kg 的 sacituzumab tirumotecan，直至疾病进展或停药。	生物：沙妥珠单抗替鲁莫替康静脉输液其他名称： SKB264 MK-2870 囊TMT
有源比较器：治疗医师的选择（TPC）通过医师的酌情决定，参与者将通过IV输注在每3周周期的第1天获得500 mg/m^2的pemetrexe，或每3周循环的第1天通过IV液或1 mg/m^2（OR 1.25 mg/m^2（如果可耐受），每3周周期的Tisotumab vedotin在每3周周期的第1天（或1 mg/m^2）每3周通过IV通过静脉输注的3周周期或每3周周期的Vinorelbine或30 mg/m^2通过IV输注或每3周的1000 mg/m^2通过IV循环的第1和8天和第8个周期的第1和第8个周期，或每次100 mg/m^2（或每次125 mg/m^2（如果耐受），iriinotecan and 15 grecan and iriinotecan and 15 gressecan and iriinotecan and 15 grand and iriinotecan and 1 15 IV输注，直到进行性疾病或中止。	药品：吉西他滨静脉输液药品：培美曲塞静脉输液药品：伊立替康静脉输液生物：替索单抗维多汀静脉输液药品：拓扑替康静脉输液药品：长春瑞滨静脉输液

参与者组/臂

干预/治疗

实验性的：沙妥珠单抗替鲁莫替康

参与者将通过静脉 (IV) 输注每两周 (Q2W) 接受一次 4 mg/kg 的 sacituzumab tirumotecan，直至疾病进展或停药。

生物：沙妥珠单抗替鲁莫替康

静脉输液

其他名称：

SKB264
MK-2870
囊TMT

有源比较器：治疗医师的选择（TPC）

通过医师的酌情决定，参与者将通过IV输注在每3周周期的第1天获得500 mg/m^2的pemetrexe，或每3周循环的第1天通过IV液或1 mg/m^2（OR 1.25 mg/m^2（如果可耐受），每3周周期的Tisotumab vedotin在每3周周期的第1天（或1 mg/m^2）每3周通过IV通过静脉输注的3周周期或每3周周期的Vinorelbine或30 mg/m^2通过IV输注或每3周的1000 mg/m^2通过IV循环的第1和8天和第8个周期的第1和第8个周期，或每次100 mg/m^2（或每次125 mg/m^2（如果耐受），iriinotecan and 15 grecan and iriinotecan and 15 gressecan and iriinotecan and 15 grand and iriinotecan and 1 15 IV输注，直到进行性疾病或中止。

药品：吉西他滨

静脉输液

药品：培美曲塞

静脉输液

药品：伊立替康

静脉输液

生物：替索单抗维多汀

静脉输液

药品：拓扑替康

静脉输液

药品：长春瑞滨

静脉输液

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in 大体时间：Up to approximately 46 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.	Up to approximately 46 months
Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in 大体时间：Up to approximately 46 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 46 months
Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in 大体时间：Up to approximately 46 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 46 months
Overall Survival (OS) in Phase 3 Portion 大体时间：Up to approximately 35 months	OS is defined as the time from randomization to death due to any cause.	Up to approximately 35 months

次要结果测量

结果测量	措施说明	大体时间
Progression-free Survival (PFS) in Phase 3 Portion 大体时间：Up to approximately 35 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.	Up to approximately 35 months
ORR in Phase 3 Portion 大体时间：Up to approximately 35 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by BICR in the Phase 3 portion will be presented.	Up to approximately 35 months
Duration of Response (DOR) in Phase 3 Portion 大体时间：Up to approximately 35 months	For participants who demonstrate CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR will be presented as assessed by BICR and analyzed by the Kaplan-Meier method for censored data.	Up to approximately 35 months
Number of Participants Experiencing One or More AEs in Phase 3 Portion 大体时间：Up to approximately 46 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 46 months
Number of Participants Discontinuing Study Treatment Due to an AE in Phase 3 Portion 大体时间：Up to approximately 46 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 46 months
Time to First Deterioration (TTD) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion 大体时间：Baseline and up to approximately 46 months	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. TTD in Global Health Status (GHS)/Quality of Life (QoL) is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in combined GHS/QoL score. The TTD in GHS/QoL (Items 29 and 30) combined score will be reported.	Baseline and up to approximately 46 months
Change from Baseline in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion 大体时间：Baseline and up to approximately 46 months	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be reported.	Baseline and up to approximately 46 months
Change from Baseline in EORTC QLQ-C30 Physical Functioning Score in Phase 3 Portion 大体时间：Baseline and up to approximately 46 months	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.	Baseline and up to approximately 46 months
Change from Baseline in EORTC QLQ-C30 Role Functioning Score in Phase 3 Portion 大体时间：Baseline and up to approximately 46 months	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.	Baseline and up to approximately 46 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

合作者

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

调查人员

研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

Merck Clinical Trials Information

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月24日

初级完成 (估计的)

2028年6月15日

研究完成 (估计的)

2028年6月15日

研究注册日期

首次提交

2024年6月10日

首先提交符合 QC 标准的

2024年6月10日

首次发布 (实际的)

2024年6月14日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

一项比较 Sacituzumab Tirumotecan (MK-2870) 单药治疗与医生选择的治疗作为复发或转移性宫颈癌参与者二线治疗的研究 (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

一项 3 期随机、活性对照、开放标签、多中心研究，比较 MK-2870 单药疗法与医生选择的治疗作为复发性或转移性宫颈癌参与者的二线治疗的疗效和安全性 (TroFuse-020/GOG -3101/ENGOT-cx20)

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

出版物和有用的链接

有用的网址

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

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