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NCT03783442CompletedPhase 3

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 29 Jul 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
649 (actual)
First submitted
18 Dec 2018
Start date
11 Dec 2018
Primary completion date
28 Feb 2022
Lead sponsor
BeiGene
NCT number
NCT03783442
EudraCT number
2018-000587-28

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 649
  • From 11 Dec 2018 to the primary completion date, 28 Feb 2022
  • 124 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  • Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  • Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
  • Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) \< 83.5 per investigator's choice
  • Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.

Other illness

  • Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  • Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
  • Evidence of complete esophageal obstruction not amenable to treatment

Who the study is looking for

  • Pathologically (histologically) confirmed diagnosis of ESCC
  • Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (124)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Coffs Harbour Base Hospital
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Coffs HarbourAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Institut Jules Bordet
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AnderlechtBelgiumUnknown status
Az Sint Jan Brugge
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BrugesBelgiumUnknown status
Grand Hopital de Charleroi - Site Notre Dame
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CharleroiBelgiumUnknown status
UZ Gent
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GhentBelgiumUnknown status
University Hospitals Leuven
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LeuvenBelgiumUnknown status
CHC MontLégia
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LiègeBelgiumUnknown status
The Fifth medical center of Chinese PLA General Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
The First Peoples Hospital of Changzhou
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ChangzhouChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Guangdong Province Traditional Chinese Medical Hospitsal
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GuangzhouChinaUnknown status
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Hainan General Hospital
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HaikouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
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HefeiChinaUnknown status
The Second Hospital of Anhui Medical University
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HefeiChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
LinYi Cancer Hospital
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LinyiChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
The Tumor Hospital Affiliated to Guangxi Medical University
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NanningChinaUnknown status
Nantong Tumor Hospital Branch North
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NantongChinaUnknown status
Quanzhou First Affliated Hospital of Fujian Medical University
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QuanzhouChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Cancer Hospital of Shantou University Medical College
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ShantouChinaUnknown status
Liaoning Cancer Hospital and Institute
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ShenyangChinaUnknown status
Shanxi Provincial Peoples Hospital
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TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Weifang Peoples Hospital
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WeifangChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital )
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WuxiChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Zhongshan Hospital Xiamen University
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XiamenChinaUnknown status
Xiangyang Central Hospital
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XiangyangChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni Thomayerova nemocnice
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PragueCzechiaUnknown status
Universitätsklinikum Hamburg-Eppendorf
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HamburgGermanyUnknown status
Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin
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HeilbronnGermanyUnknown status
Universitäres Krebszentrum Leipzig
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LeipzigGermanyUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Institut Catala Doncologia
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BarcelonaSpainUnknown status
Hospital Universitario Vall Dhebron
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BarcelonaSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Regional Universitario de Malaga
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MálagaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status
Chru de Brest Hopital Cavale Blanche
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BrestFranceUnknown status
Chu Besancon Hopital Jean Minjoz
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DoubsFranceUnknown status
Hopital Franco Britannique
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LevalloisPerretFranceUnknown status
Centre Oscar Lambret
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LilleFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Hopital Saint Antoine Service Dhepato Gastro Enterologie
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ParisFranceUnknown status
CHU Bordeaux - Hopital Haut-Leveque
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PessacFranceUnknown status
Chu de Poitiers Site de La Mileterie
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PoitiersFranceUnknown status
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblainFranceUnknown status
The Christie Hospital
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Greater ManchesterUnited KingdomUnknown status
Guys and St Thomas Hospital Nhs Foundation Trust
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LondonUnited KingdomUnknown status
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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MeldolaItalyUnknown status
Istituto Europeo di Oncologia
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MilanItalyUnknown status
Istituto Nazionale Tumori Fondazione G. Pascale
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NaplesItalyUnknown status
IOV - Istituto Oncologico Veneto IRCCS
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PadovaItalyUnknown status
Azienda Ospedaliera Universitaria Delle Marche
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TorretteItalyUnknown status
Hyogo Cancer Center
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AkashiShiJapanUnknown status
Akita University Hospital
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AkitashiJapanUnknown status
Johas Kansai Rosai Hospital
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AmagasakishiJapanUnknown status
National Cancer Center Hospital
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ChūōkuJapanUnknown status
NHO Kyushu Cancer Center
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Medical Center
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FukuokacityJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Saitama Cancer Center
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KitaadachigunJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
University Hospital, Kyoto Prefectural Univ of Medicine
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KyotoShiJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Osaka International Cancer Institute
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OsakashiJapanUnknown status
The University of Osaka Hospital
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SuitashiJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Seoul National University Bundang Hospital
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BundangGu SeongnamSiSouth KoreaUnknown status
Cha Bundang Medical Center, Cha University
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BundangGu SeongnamSiSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DalseoguSouth KoreaUnknown status
Smg Snu Boramae Medical Center
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DongjakGuSouth KoreaUnknown status
Korea University Guro Hospital
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GuroGuSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunGunSouth KoreaUnknown status
Gachon University Gil Medical Center
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NamdongGuSouth KoreaUnknown status
The Catholic University of Korea, Seoul St Marys Hospital
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SeochoGuSouth KoreaUnknown status
Samsung Medical Center - Hematology & Oncology
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SongpaGuSouth KoreaUnknown status
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
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BrzozówPolandUnknown status
Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie
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KoszalinPolandUnknown status
Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii
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OlsztynPolandUnknown status
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
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WarsawPolandUnknown status
Medisprof Cancer Center
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ClujNapocaRomaniaUnknown status
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
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ClujNapocaRomaniaUnknown status
Radiotherapy Center Cluj
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ClujNapocaRomaniaUnknown status
Sc Centrul de Oncologie Sf Nectarie Srl
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CraiovaRomaniaUnknown status
Arkhangelsk Regional Clinical Oncological Dispensary
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ArkhangelskRussiaUnknown status
RBIH "Ivanovo Regional Oncological Dispensary"
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IvanovoRussiaUnknown status
State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary
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KuzmolovskyRussiaUnknown status
Orenburg Regional Clinical Oncology Center
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OrenburgRussiaUnknown status
Rostov State Medical University
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RostovonDonRussiaUnknown status
Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf
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SaintPetersburgRussiaUnknown status
Pavlov First Saint Petersburg State Medical University
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SaintPetersburgRussiaUnknown status
Chiayi Chang Gung Memorial Hospital
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Chiayi CityTaiwanUnknown status
Chi Mei Hospital Liouying
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Liuying DistTaiwanUnknown status
China Medical University Hospital
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North Dist.TaiwanUnknown status
Chi Mei Medical Center
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Yongkang DistTaiwanUnknown status
Smilow Cancer Hospital At Yale
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New HavenUnited StatesUnknown status
Renovatio Clinical
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The WoodlandsUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.