Esophageal Cancer Clinical Trial

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second 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 second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Key Exclusion Criteria:

Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (immunotherapy-drugs-are-boosting-survival/" >PD-L1)
Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
Active brain or leptomeningeal metastasis.
Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
Known history of Human Immunodeficiency Virus (HIV)
Has cardiovascular risk factors
Pregnant or breastfeeding woman.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

512

Study ID:

NCT03430843

Recruitment Status:

Completed

Sponsor:

BeiGene

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There are 130 Locations for this study

See Locations Near You

St. Joseph Heritage Healthcare
Fullerton California, 92835, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles California, 90089, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Toledo Clinic Cancer Center
Toledo Ohio, 43623, United States
San Antonio Military Medical Center
Fort Sam Houston Texas, 78234, United States
Millennium Oncology
Houston Texas, 77090, United States
Imelda Ziekenhuis
Antwerp , 2600, Belgium
UZ Antwerpen
Antwerp , 2650, Belgium
Cliniques universitaires Saint-Luc
Brussels , 1000, Belgium
University Hospitals Leuven
Leuven , 3000, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman
Liege , 4000, Belgium
Anhui Medical University - The Second Hospital
Hefei Anhui, 23060, China
Beijing Friendship Hospital
Beijing Beijing, 10005, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Peking Union Medical College Hospital
Beijing Beijing, 10073, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou Fujian, 35000, China
Fujian Provincial Cancer Hospital
Fuzhou Fujian, 35001, China
The First Affiliated Hospital of Xiamen University
Xiamen Fujian, 36100, China
The First Hospital, Sun Yat-sen University
Guangzhou Guangdong, 51008, 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
Peking University Shenzhen Hospital
Shenzhen Guangdong, 51803, China
Affiliated Hospital of Hebei University
Baoding Hebei, 71000, China
Fourth Hospital of Hebei Medical University
Shijiazhuang Hebei, 05001, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang Henan, 45310, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Hubei Cancer Hospital
Wuhan Hubei, 40003, China
Xiangyang Central Hospital
Xiangyang Hubei, 44100, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
The First People's Hospital Of Changzhou
Changzhou Jiangsu, 21300, China
Huai'an Second People's Hospital
Huai'an Jiangsu, 22300, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21002, China
Nanjing Drum Tower Hospital
Nanjing Jiangsu, 21008, China
Nantong Tumor Hospital
Nantong Jiangsu, 22600, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Jiangsu, 22100, China
Jiangxi Cancer Hospital
Nanchang Jiangxi, 33002, China
The First Hospital of Jinlin University
Changchun Jilin, 13002, China
Shandong Cancer Hospital
Jinan Shandong, 25011, China
Shandong Linyi Tumor Hospital
Linyi Shandong, 37130, China
WeiFang People's Hospital
Weifang Shandong, 26100, China
Fudan Cancer Hospital
Shanghai Shanghai, 20003, China
Shanxi Provincial People's Hospital
Taiyuan Shanxi, 14010, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
Xi'an Shanxi, 71001, China
Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital
Chengdu Sichuan, 61007, China
Yunnan Cancer Hospital - Oncology
Kunming Yunnan, 65010, China
Hangzhou First People's Hospital
Hangzhou Zhejiang, 31000, China
The First Affiliated Hospital, Zhejiang University
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
CHRU Besançon
Besançon , 25000, France
CHRU de Brest Hôpital Morvan
Brest , 29200, France
Centre Georges-Francois Leclerc
Dijon , 21079, France
Center Oscar Lambret - Alliance Member
Lille , 59000, France
Hopital Prive Jean Mermoz
Lyon , 69008, France
ICM Val d'Aurelle
Montpellier , 34298, France
Comprehensive Cancer Center-Gustave Roussy
Paris , 94805, France
Hôpital Haut-Lévêque
Pessac , 33604, France
CHU de Poitiers
Poitiers , 86021, France
Centre de Lutte Contre le Cancer
Saint-Herblain , 44805, France
Clinique Sainte-Anne
Strasbourg , 67000, France
Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)
Berlin , 13353, Germany
Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik
Dresden , 01307, Germany
Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
Hamburg , 20249, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitatsklinikum Koln, Innere Medizin I
Koln , 50937, Germany
Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)
Leipzig , 04103, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz , 55131, Germany
Universitaetsmedizin Mannheim, II. Medizinische Klinik
Mannheim , 68167, Germany
Kliniken Nordoberpfalz, Klinikum Weiden
Weiden , 92637, Germany
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania , 95122, Italy
AUSL della Romagna, Osp. degli Infermi
Faenza , 48018, Italy
Irccs Irst
Meldola , 47014, Italy
AOU - Seconda Università degli Studi di Napoli
Naples , 80131, Italy
AOU San Luigi di Orbassano
Orbassano , 10043, Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza , 29121, Italy
A.O.U. Pisana, Stabilimento di Santa Chiara
Pisa , 56126, Italy
AO Citta della Salute e della Scienza di Torino - Presidio O
Torino , 10126, Italy
National Cancer Center Hospital East
Kashiwa Chiba, 100-0, Japan
Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
Hyogo Cancer Center
Akashi Hyogo, 673-8, Japan
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan
St. Marianna University School of Medicine Hospital
Kawasaki Kanagawa, 216-8, Japan
Kindai University Nara Hospital
Ikoma Nara, 630-0, Japan
Osaka University Hospital
Suita Osaka, 565-0, Japan
Saitama Cancer Center
Ina Saitama, 362-0, Japan
Shizuoka Cancer Center
Nagaizumi Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku Tokyo, 135-8, Japan
Akita University Hospital
Akita , 010-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
National Kyushu Cancer Center
Fukuoka , 811-1, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
Kagawa University Hospital
Kagawa , 761-0, Japan
Kochi Health Sciences Center
Kochi , 781-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Osaka Medical College Hospital
Osaka , 569-8, Japan
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Asan Medical Center - Oncology
Seoul , 5505, Korea, Republic of
Chonnam National University Hwasun Hospital
Seoul , 58128, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Korea University Guro Hospital
Seoul , 8308, Korea, Republic of
Hospital del Mar
Barcelona Madrid, 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Institut Català d'Oncologia
Madrid , 08908, Spain
Hospital Madrid Norte Sanchinarro
Madrid , 28006, Spain
Hospital Universitario Gregorio Marañon
Madrid , 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia , 30120, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Changhua Christian Hospital
Changhua NAP, 500-0, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 833, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Chi Mei Medical Center
Tainan , 710, Taiwan
Chi Mei Hospital, Liouying
Tainan , 73657, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Guys & St. Thomas Hospital
London , SE1 9, United Kingdom
St. George's Hospital
London , SW17 , United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
Imperial NHS Trust
London , W12 0, United Kingdom
Sarah Cannon Research Institute-London
London , W1G 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Mount Vernon Cancer Centre
Northwood , HA6 2, United Kingdom
The Royal Marsden NHS Foundation Trust - Haemato-Oncology
Sutton , SM2 5, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

512

Study ID:

NCT03430843

Recruitment Status:

Completed

Sponsor:


BeiGene

How clear is this clinincal trial information?

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