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El ensayo clínico NCT05904886 (SKYSCRAPER-14) para Carcinoma hepatocelular está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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RocheA Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152) (SKYSCRAPER-14) Fase III 687 Anticuerpo monoclonal
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05904886 (SKYSCRAPER-14) está diseñado para estudiar el tratamiento de Carcinoma hepatocelular. Es un estudio intervencionista de Fase III. Su estado actual es: activo, no reclutando. El estudio se inició el 14 de septiembre de 2023, con el objetivo de reclutar a 687 participantes. Dirigido por Roche, se espera que finalice el 1 de septiembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 31 de diciembre de 2025.
Resumen
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC.
Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus ti...
Mostrar másTítulo oficial
A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Condiciones médicas
Carcinoma hepatocelularPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- SKYSCRAPER-14
- CO44668
- 2023-503422-39-00 (Identificador de registro) (EU CT Number)
Número del NCT
Inicio del estudio (real)
2023-09-14
Última actualización
2025-12-31
Fecha de finalización (estimada)
2026-09-01
Inscripción (prevista)
687
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Activo, no reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalAtezolizumab + Bevacizumab + Tiragolumab Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Atezolizumab Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Bevacizumab Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle. Tiragolumab Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle. |
Comparador placeboAtezolizumab + Bevacizumab + Placebo Atezolizumab, bevacizumab plus placebo will be administered Q3W until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Atezolizumab Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Bevacizumab Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle. PLACEBO Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Investigator-assessed Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first (up to approximately 21 months) | |
Overall Survival (OS) | From randomization to death from any cause (up to approximately 36 months) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Investigator-assessed Confirmed Objective Response Rate (ORR) According to RECIST v1.1 | From randomization up to approximately 21 months | |
Investigator-assessed Duration of Response (DOR) According to RECIST v1.1 | From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months) | |
Investigator-assessed PFS Rate According to RECIST v1.1 at 6 and 12 Months | Month 6, Month 12 | |
OS Rate at 1 and 2 Years | Year 1, Year 2 | |
Investigator-assessed PFS According to HCC mRECIST | From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months) | |
Investigator-assessed Confirmed ORR According to HCC mRECIST | From randomization up to approximately 21 months | |
Investigator-assessed DOR According to HCC mRECIST | From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months) | |
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30 (EORTC QLQ-C30) Subscales | The following subscales of the EORTC QLQ-C30 will be used for the assessment: global health status/quality-of-life (GHS/QoL), physical functioning and role functioning. GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome. | Up to approximately 21 months |
Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30 | GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome. | Up to approximately 21 months |
Percentage of Participants With Adverse Events (AEs) | Up to approximately 36 months | |
Serum Concentrations of Atezolizumab | Prior to the first infusion and 30 minutes after atezolizumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months) | |
Serum Concentrations of Tiragolumab | Prior to the first infusion and 30 minutes after tiragolumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months) | |
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months) | |
Percentage of Participants With ADAs to Atezolizumab | Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
- Disease that is not amenable to curative surgical and/or locoregional therapies
- No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization
- Child-pugh Class A within 7 days prior to randomization
- Adequate hematologic and end-organ function
- Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
- Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.
- Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
- Treatment with systemic immunostimulatory agents
- Treatment with systemic immunosuppressive medication
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
- Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Chugai PharmaceuticalNo hay datos de contacto.
171 Centros del estudio en 27 países
Navarre
Hospital de Navarra, Navarra, Navarre, 31008, Spain
Clinica Universitaria de Navarra, Pamplona/iruña, Navarre, 31008, Spain
Principality of Asturias
Hospital Universitario Central de Asturias, Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain
Hospital Duran i Reynals, Barcelona, 08907, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico, Jaén, 23007, Spain
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia, Madrid, 28027, Spain
Hospital Clinico San Carlos, Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro, Madrid, 28222, Spain
Hospital Clinico de Valencia, Valencia, 46010, Spain
Mexico CITY (federal District)
OncoMed, Mexico City, Mexico CITY (federal District), 03100, Mexico
Centro Medico Nacional Siglo Xxi - Imss, Mexico City, Mexico CITY (federal District), 06720, Mexico
Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán, Mexico City, Mexico CITY (federal District), 14000, Mexico
Oaxaca
Centro de Investigacion Clinica de Oaxaca, Oaxaca City, Oaxaca, 68020, Mexico
PanOncology Trials, San Juan, 00935, Puerto Rico
Arkansas
Genesis Cancer Center, Hot Springs, Arkansas, 71913, United States
California
UCSF Fresno at Community Cancer Institute, Clovis, California, 93611, United States
City of Hope Cancer Center, Duarte, California, 91010, United States
University of California San Diego Moores Cancer Center, La Jolla, California, 92037, United States
University of Southern California, Los Angeles, California, 90033, United States
Stanford Cancer Center, Palo Alto, California, 94304, United States
Va Palo Alto Health Care System, Palo Alto, California, 94304, United States
UCLA Cancer Center, Santa Monica, California, 90404, United States
Connecticut
Hartford Healthcare Cancer Institute at Hartford Hospital, Hartford, Connecticut, 06106, United States
District of Columbia
MedStar Washington Hosp Center, Washington D.C., District of Columbia, 20010, United States
Florida
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, 33901, United States
Miami VA Healthcare System, Miami, Florida, 33125, United States
Florida Cancer Specialist, North Region, St. Petersburg, Florida, 33705, United States
Illinois
University of Illinois, Chicago, Illinois, 60612, United States
Kentucky
Norton Cancer Institute - Audubon, Louisville, Kentucky, 40217, United States
Louisiana
Ochsner Cancer Inst., New Orleans, Louisiana, 70121, United States
Maryland
Mercy Medical Center, Baltimore, Maryland, 21202, United States
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503, United States
Minnesota
Mayo Clinic Rochester, Rochester, Minnesota, 55905, United States
Minnesota Oncology Hematology Woodbury, Woodbury, Minnesota, 55125, United States
Missouri
Washington Uni School of Medicine, St Louis, Missouri, 63110, United States
New York
NYU Langone, New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
Columbia University, New York, New York, 10032-3725, United States
Montefiore Medical Center, The Bronx, New York, 10461, United States
James J Peters VA Hospital / Mental Illness Research Education and Clinic Center, The Bronx, New York, 10468, United States
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Pennsylvania
Thomas Jefferson Uni, Philadelphia, Pennsylvania, 19107, United States
Texas
North Texas VA Medical Center, Dallas, Texas, 75216, United States
Kelsey Seybold Clnic, Houston, Texas, 77005, United States
Washington
Virginia Mason Medical Center, Seattle, Washington, 98101, United States
Swedish Cancer Inst., Seattle, Washington, 98104, United States
Wisconsin
Univ of Wisconsin-Madison, Madison, Wisconsin, 53792, United States
Cliniques Universitaires St-Luc, Brussels, 1200, Belgium
UZ Antwerpen, Edegem, 2650, Belgium
AZ Delta (Campus Rumbeke), Roeselare, 8800, Belgium
Espírito Santo
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, 29055-450, Brazil
Minas Gerais
Oncoclínicas do Brasil - BELO HORIZONTE, Belo Horizonte, Minas Gerais, 30170-080, Brazil
Pernambuco
Hospital do Cancer de Pernambuco - HCP, Recife, Pernambuco, 50040-000, Brazil
Rio Grande do Sul
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
São Paulo
Hospital de Cancer de Barretos, Barretos, São Paulo, 14784-400, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo, São Paulo, 01246-000, Brazil
Clinicas Oncologicas Integradas - COI, Rio de Janeiro, 22290-160, Brazil
Ontario
Juravinski Hospital, Hamilton, Ontario, L8V 1C3, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N 3M5, Canada
Quebec
Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre - Glen Site, Montreal, Quebec, H4A 3J1, Canada
Baoji Central Hospital, Baoji, 721008, China
Beijing Cancer Hospital, Beijing, 100142, China
The First Hospital of Jilin University, Changchun, 130021, China
Peoples Hospital of Hunan Province, Changsha, 410007, China
Hunan Cancer Hospital, Changsha, 410013, China
West China Hospital - Sichuan University, Chengdu, 610047, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University, Fuzhou, 350025, China
Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China
Sun yat-sen University Cancer Center, Guangzhou, China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, 310003, China
Zhejiang Provincial People?s Hospital, Hangzhou, 310014, China
Harbin Medical University Cancer Hospital, Harbin, 150081, China
Anhui Provincial Hospital, Hefei, 230001, China
The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China
Lishui Central Hospital, Lishui, 323000, China
Zhongshan Hospital Fudan Unvierstiy, Shanghai, 200032, China
Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, 200127, China
Shengjing Hospital of China Medical University, Shenyang, 110004, China
Tianjin Cancer Hospital, Tianjin, 300060, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, 430030, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, 710061, China
Xi'an Inernational Medical Center Hospital, Xi'an, 710119, China
Polyclinique Internationale Sainte Anne- Marie (PISAM), Abidjan, BP 1463 Abidjan, Côte d’Ivoire
Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO), Abidjan, Côte d’Ivoire
CHU CAEN - Hôpital de la Côte de Nacre, Caen, 14033, France
CHRU de Lille - Hopital Claude Huriez, Lille, 59037, France
Hopital Dupuytren, Limoges, 87042, France
Fondation Hopital Saint Joseph, Marseille, 13285, France
Hopital Hotel Dieu Et Hme, Nantes, 44093, France
APHP - Hopital Saint Antoine, Paris, 75571, France
Hopital Robert Debre, Reims, 51092, France
Centre Hospitalier Valence, Valence, 26953, France
Hopitaux de Brabois - Gastro-Entereologie, Vandœuvre-lès-Nancy, 54511, France
Hopital Paul Brousse, Villejuif, 94804, France
Klinikum Esslingen, Esslingen am Neckar, 73730, Germany
Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie, Magdeburg, 39120, Germany
Uniklinik Mainz, Mainz, 55131, Germany
Universität Tübingen, Tübingen, 72076, Germany
KBTH, Accra, 0000, Ghana
Sweden Ghana Medical Center, Accra, Ghana
Queen Mary Hospital, Hong Kong, Hong Kong
Prince of Wales Hosp, Shatin, Hong Kong
Apulia
Az. Osp. G. Panico, Tricase, Apulia, Italy
Emilia-Romagna
A.O. S. Orsola Malpighi, Bologna, Emilia-Romagna, 40138, Italy
Lazio
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Lazio, 00168, Italy
Liguria
Az. Osp. Uni Ria San Martino, Genoa, Liguria, 16132, Italy
Lombardy
IRCCS Istituto Clinico Humanitas, Rozzano, Lombardy, 20089, Italy
Sicily
A.O.U. Policlinico Paolo Giaccone, Palermo, Sicily, 90127, Italy
Veneto
A.O.U.I. Verona-Ospedale Policlinico G.B. Rossi Borgo Roma, Verona, Veneto, 37134, Italy
Fujita Health University Hospital, Aichi, 470-1192, Japan
Chiba University Hospital, Chiba, 260-8677, Japan
National Cancer Center Hospital East, Chiba, 277-8577, Japan
Ehime Prefectural Central Hospital, Ehime, 790-0024, Japan
Kurume University Hospital, Fukuoka, 830-0011, Japan
Hiroshima University Hospital, Hiroshima, 734-8551, Japan
Sapporo Kosei General Hospital, Hokkaido, 060-0033, Japan
Hokkaido University Hospital, Hokkaido, 060-8648, Japan
Kanazawa University Hospital, Ishikawa, 920-8641, Japan
Toranomon Branch Hospital, Kanagawa, 213-8587, Japan
Kanagawa Cancer Center, Kanagawa, 241-8515, Japan
Kitasato University Hospital, Kanagawa, 252-0375, Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto, 602-8566, Japan
Kyoto University Hospital, Kyoto, 606-8507, Japan
Iwate Medical University Hospital, Numakunai, 028-3695, Japan
The University of Osaka Hospital, Osaka, 565-0871, Japan
Kindai University Hospital, Osaka, 589-8511, Japan
Jichi Medical University Hospital, Tochigi, 329-0498, Japan
Toranomon Hospital, Tokyo, 105-8470, Japan
Japanese Red Cross Musashino Hospital, Tokyo, 180-8610, Japan
University of Nairobi - Institute of Tropical and Infectious Diseases, Nairobi, Kenya
Auckland City Hospital, Auckland, 1023, New Zealand
Christchurch Hospital, Christchurch, 8011, New Zealand
Wellington Hospital, Wellington, 6021, New Zealand
Jos University Teaching Hospital, Jos, 930232, Nigeria
Lagos University Teaching Hospital Lagos (LUTH), Lagos State, Lagos, Nigeria
ID Clinic, Mysłowice, 41-400, Poland
NIO im Marii Sklodowskiej-Curie, Warsaw, 02-034, Poland
National Cancer Centre, Singapore, 168583, Singapore
Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, 2193, South Africa
Limpopo Cancer Research Institute, Polokwane, 0700, South Africa
National Cancer Center, Goyang-si, 10408, South Korea
CHA Bundang Medical Center, Gyeonggi-do, 13496, South Korea
Chonnam National University Hwasun Hospital, Jeollanam-do, 58128, South Korea
Severance Hospital, Yonsei University Health System, Seoul, 003-722, South Korea
Seoul National University Hospital, Seoul, 03080, South Korea
Asan Medical Center, Seoul, 05505, South Korea
Samsung Medical Center, Seoul, 06351, South Korea
Ulsan University Hosiptal, Ulsan, 44033, South Korea
China Medical University Hospital, Taichung, 404, Taiwan
National Cheng Kung University Hospital, Tainan, 00704, Taiwan
Chi-Mei Medical Centre, Tainan, 710, Taiwan
National Taiwan Uni Hospital, Taipei, 100, Taiwan
Chang Gung Medical Foundation - Linkou, Taoyuan District, 333, Taiwan
Chulalongkorn Hospital, Bangkok, 10330, Thailand
Ramathibodi Hospital, Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, 50200, Thailand
Khon Kaen Uni, Khon Kaen, 40002, Thailand
Adana Baskent University Medical Faculty, Adana, 01220, Turkey (Türkiye)
Ankara Bilkent City Hospital, Ankara, 06490, Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital, Ankara, 06500, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, 22030, Turkey (Türkiye)
?zmir Medical Point, Kar?iyaka, 35575, Turkey (Türkiye)
Uganda Cancer Institute, Kampala, Uganda
Western General Hospital, Edinburgh, EH4 2XU, United Kingdom
Royal Free Hospital, London, NW3 2QG, United Kingdom
Hammersmith Hospital, London, W12 0HS, United Kingdom