Esophageal Cancer Clinical Trial

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

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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 (immunotherapy-drugs-are-boosting-survival/" >PD-L1) or PD-L2
Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
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
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.
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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

649

Study ID:

NCT03783442

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 150 Locations for this study

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Smilow Cancer Hospital at Yale-New Haven - Neurology
New Haven Connecticut, 06510, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Allegheny General Hospital (AGH)
Pittsburgh Pennsylvania, 15212, United States
Medical University of South Carolina Hollings Cancer Center
Charleston South Carolina, 29425, United States
University of Texas Health Science Center of San Antonio
San Antonio Texas, 78229, United States
Renovatio Clinical
The Woodlands Texas, 77389, United States
Coffs Harbour Hospital
Coffs Harbour Pacific Highway, 2450, Australia
Townsville Hospital
Douglas Queensland, 4814, Australia
Ashford Cancer Centre Research
Kurralta Park South Australia, 6008, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
St Vincent's Hospital
Fitzroy Victoria, 3065, Australia
Ballarat Oncology & Haematology Services
Wendouree Victoria, 3355, Australia
Antwerp University Hospital
Edegem Antwerpen, 2650, Belgium
Institut Jules Bordet - Oncologie Médicale
Anderlecht Brussels Capital Region, 1070, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi Hainaut, 6000, Belgium
UZ Gent - Radiologie
Gent Oost-Vlaanderen, 9000, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven Vlaams Brabant, 3000, Belgium
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
Brugge West-Vlaanderen, 8000, Belgium
CHC Mont Legia
Liège , 4000, Belgium
CHU Liège Sart Tilman
Liège , 4000, Belgium
Anhui Provincial Cancer Hospital
Hefei Anhui, 23008, China
Anhui Medical University - The Second Hospital
Hefei Anhui, 23060, China
The Second Affiliated Hospital of Anhui Medical University
Hefei Anhui, 23060, China
Beijing Friendship Hospital - Oncology
Beijing Beijing, 10005, China
The Fifth Medical Center of Chinese PLA General Hospital
Beijing Beijing, 10007, China
Chinese PLA General Hospital
Beijing Beijing, 10008, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Peking Union Medical College Hospital - Oncology
Beijing Beijing, 10073, China
Fujian Provincial Cancer Hospital - Oncology
Fuzhou Fujian, 35001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou Fujian, 35005, China
Zhongshan Hospital Xiamen University
Xiamen Fujian, 36100, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou Guangdong, 51000, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou Guangdong, 51012, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou Guangdong, 51065, China
Cancer Hospital of Shantou University Medical College
Shantou Guangdong, 51503, China
Cancer Hospital of Guangxi Medical University
Nanning Guangxi, , China
Hainan General Hospital - Oncology
Haikou Hainan, , China
Affiliated Tumor Hospital of Harbin Medical University
Haerbin Heilongjiang, 15008, China
The First Affiliated Hospital of Zhengzhou University - Oncology
Henan Henan, 45005, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang Henan, 45310, China
Henan Cancer Hospital - Oncology
Zhengzhou Henan, 45000, China
Hubei Cancer Hospital - Oncology
Wuhan Hubei, 43007, China
Xiangyang Central Hospital
Xiangyang Hubei, 44102, China
Hunan Cancer Hospital - GCP Office
Changsha Hunan, 41001, China
The First People's Hospital of Changzhou - Oncology
Changzhou Jiangsu, 21300, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21002, China
Nantong Cancer Hospital
Nantong Jiangsu, , China
Affiliated Hospital of Jiangnan University
Wuxi Jiangsu, 21406, China
The Affiliated Hospital of Xuzhou Medical University - Radiology
Xuzhou Jiangsu, , China
Northern Jiangsu People's Hospital
Yangzhou Jiangsu, 22500, China
The Second Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
Shenyang Liaoning, 11001, China
Quanzhou First Hospital - Radiotherapy/Nuclear Medicine
Quanzhou Quanzhou, , China
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan Shandong, 25011, China
Linyi Cancer Hospital
Linyi Shandong, 27600, China
WeiFang People's Hospital
Weifang Shandong, , China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, , China
Shanxi Provincial People's Hospital
Taiyuan Shanxi, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China
The First Affiliated Hospital of Zhejiang University
Hangzhou Zhejiang, 31000, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Anhui Provincial Hospital - Oncology
Hefei , 23000, China
The First Affiliated Hospital of Xiamen University - Oncology
Xiamen , 36100, China
Fakultní Nemocnice Olomouc
Olomouc , 779 0, Czechia
Thomayerova nemocnice
Praha 4 , 140 5, Czechia
Nemocnice Na Bulovce
Praha 8 , 180 8, Czechia
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
Brest Cedex Bretagne, 29609, France
CHRU de Besançon- Hôpital Jean Minjoz
Besançon Cedex Doubs, 25030, France
CHU Bordeaux Hôpital Du Haut-Lévêque
Pessac Cedex Gironde, 33608, France
Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber
Levallois-Perret Hauts-de-Seine, 92300, France
ICO
Saint-Herblain Loire-Atlantique, 44805, France
Center Oscar Lambret - Alliance Member
Lille Nord, 59000, France
Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie
Paris Cedex 12 Paris, 75571, France
Centre Léon Bérard
Lyon Rhône, 69008, France
Centre Hospitalier Universitaire de Poitiers
Poitiers Vienne, 86000, France
Hopital Europeen Georges Pompidou - Digestive Oncology
Paris , 75015, France
Groupe Hospitalier Paris Saint Joseph - Oncologie
Paris , 75074, France
SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin
Heilbronn Baden-Württemberg, 74078, Germany
University Hospital Tuebingen
Tuebingen Baden-Württemberg, 72076, Germany
Johannes Wesling Klinikum Minden
Minden Nordrhein-Westfalen, 32429, Germany
Universitätsmedizin Mainz
Mainz Rheinland-Pfalz, 55101, Germany
University Hospital Of Leipzig
Leipzig Sachsen, 04103, Germany
University Hospital Hamburg- Eppendorf
Hamburg , 20251, Germany
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
Torino Ancona, 60126, Italy
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio
Meldola Emilia-Romagna, 47014, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
Ancona , 60126, Italy
Ieo, Irccs
Milano , 20141, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
Napoli , 80131, Italy
Istituto Oncologico Veneto IOV-IRCCS
Padova , 35128, Italy
SO S.Chiara, AOU Pisana - Oncologia 2
Pisa , 56126, Italy
National Cancer Center Hospital East - Gastrointestinal Oncology
Kashiwa Chiba, 277-8, Japan
Kyushu Medical Center - Gastroenterological Surgery
Fukuoka Hukuoka, 810-8, Japan
National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology
Fukuoka Hukuoka, 811-1, Japan
Kobe City Medical Center General Hospital - Medical Oncology
Kobe Hyogo, 650-0, Japan
Kagawa University Hospital - Oncology
Kita-gun Kagawa, 761-0, Japan
Kanagawa Cancer Center - Gastroenterological surgery
Yokohama Kanagawa, 241-8, Japan
University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology
Kamigyō-ku Kyoto, 602-8, Japan
Kindai University Nara Hospital
Ikoma Osaka, 630-0, Japan
Osaka University Hospital - Medical Oncology
Suita Osaka, 565-0, Japan
National Cancer Center Hospital - Gastrointestinal Oncology
Chuo Ku Tokyo, 104-0, Japan
Hyogo Cancer Center
Akashi , 673-8, Japan
Akita University Hospital - Pediatrics
Akita-shi , 010-8, Japan
Kansai Rosai Hospital - Gastroenterological Surgery
Amagasaki , 660-8, Japan
Hiroshima University Hospital - Gastrointestinal Surgery
Hiroshima , 734-8, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Osaka International Cancer Institute - Clinical Oncology
Osaka , 541-8, Japan
Saitama Cancer Center - Gastroenterology
Saitama , 362-0, Japan
Seoul National University Bundang Hospital - Hematology/Oncology
Seongnam-si Gyeonggido [Kyonggi-do], 13620, Korea, Republic of
CHA Bundang Medical Center, CHA University - Oncology
Seongnam-si Gyeonggido, 13496, Korea, Republic of
Gachon University Gil Medical Center - Oncology
Incheon Incheon Gwang'yeogsi [Inch'n-K, 21565, Korea, Republic of
Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic
Hwasun Jeonranamdo [Chollanam-do], 58128, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul Seoul Teugbyeolsi [Seoul-T'ukp], 6591, Korea, Republic of
Samsung Medical Center - Hematology-Oncology
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 06351, Korea, Republic of
SMG-SNU Boramae Medical Center - Oncology
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 07061, Korea, Republic of
Korea University Guro Hospital - Hematology-Oncology
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 08308, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , 42601, Korea, Republic of
Asan Medical Center - Oncology
Seoul , 05505, Korea, Republic of
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa Mazowieckie, 02-03, Poland
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
Brzozow Podkarpackie, 36-20, Poland
Szpital Wojewodzki w Koszalinie
Koszalin Pomorskie, 75-58, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn Warminsko-mazurskie, 10-22, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan Wielkopolskie, 60-84, Poland
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
Cluj-Napoca Cluj, 40001, Romania
Radiotherapy Center Cluj
Floreşti Cluj, 40728, Romania
Centrul de Oncologie Sf. Nectarie
Craiova Dolj, 20034, Romania
Institutul Clinic Fundeni
Bucuresti , 02232, Romania
Spitalul Clinic Coltea
Bucuresti , 03017, Romania
Medisprof
Cluj-Napoca , 40064, Romania
Centrul de Oncologie Euroclinic
Iaşi , 70010, Romania
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk Arkhangel'skaya Oblast', 16304, Russian Federation
Leningrad Regional Oncology Dispensary
Kuz'molovskiy Leningradskaya Oblast, 18866, Russian Federation
Orenburg Regional Clinical Oncology Center
Orenburg Orenburgskaya Oblast, 46002, Russian Federation
Rostov Research Institute of Oncology (RRIO)
Rostov-Na-Donu Rostovskaya Oblast, 34403, Russian Federation
The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
City Oncology Dispensary
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15301, Russian Federation
Petrov Research Institute of Oncology
Saint Petersburg , 19775, Russian Federation
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Institut Catalá d´Oncología (I.C.O.)
L'Hospitalet De Llobregat Barcelona, 08907, Spain
Hospital Madrid Norte Sanchinarro
Sanchinarro Madrid, 28050, Spain
Hospital Universitario Vall d'Hebrón
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
H.U.V.Arrixaca
Murcia , 30120, Spain
Hospital Universitario Virgen De La Victoria
Málaga , 29010, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Kaohsiung Veterans General Hospital - Thoracic Surgery
Kaohsiung , 813, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung , 833, Taiwan
China Medical University Hospital - Oncology - Taichung
Taichung , 40447, Taiwan
Chi Mei Medical Center - YongKang - Chi Mei Medical Center
Tainan , 71004, Taiwan
Chi Mei Hospital, Liouying - Department of Oncology
Tainan , 73657, Taiwan
Guys and St Thomas' Hospital
London City Of London, SE1 9, United Kingdom
Royal Marsden NHS Foundation Trust Sutton
London City Of London, SM2 5, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London City Of London, SW3 6, United Kingdom
Mount Vernon Cancer Centre
Northwood England, HA6 2, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre
Maidstone Kent, ME16 , United Kingdom
Beatson West of Scotland Cancer Centre - Oncology
Glasgow Scotland, G12 0, United Kingdom
The Christie NHS Foundation Trust - Oak Road Treatment Centr
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

649

Study ID:

NCT03783442

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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