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.
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.
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There are 130 Locations for this study
Fullerton California, 92835, United States
Los Angeles California, 90089, United States
Warrenville Illinois, 60555, United States
Detroit Michigan, 48202, United States
Toledo Ohio, 43623, United States
Fort Sam Houston Texas, 78234, United States
Houston Texas, 77090, United States
Antwerp , 2600, Belgium
Antwerp , 2650, Belgium
Brussels , 1000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Hefei Anhui, 23060, China
Beijing Beijing, 10005, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35000, China
Fuzhou Fujian, 35000, China
Fuzhou Fujian, 35001, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51065, China
Shantou Guangdong, 51503, China
Shenzhen Guangdong, 51803, China
Baoding Hebei, 71000, China
Shijiazhuang Hebei, 05001, China
Harbin Heilongjiang, 15008, China
Xinxiang Henan, 45310, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45005, China
Wuhan Hubei, 40003, China
Xiangyang Hubei, 44100, China
Changsha Hunan, 41001, China
Changzhou Jiangsu, 21300, China
Huai'an Jiangsu, 22300, China
Nanjing Jiangsu, 21002, China
Nanjing Jiangsu, 21008, China
Nantong Jiangsu, 22600, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, 33002, China
Changchun Jilin, 13002, China
Jinan Shandong, 25011, China
Linyi Shandong, 37130, China
Weifang Shandong, 26100, China
Shanghai Shanghai, 20003, China
Taiyuan Shanxi, 14010, China
Xi'an Shanxi, 71001, China
Chengdu Sichuan, 61007, China
Kunming Yunnan, 65010, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Besançon , 25000, France
Brest , 29200, France
Dijon , 21079, France
Lille , 59000, France
Lyon , 69008, France
Montpellier , 34298, France
Paris , 94805, France
Pessac , 33604, France
Poitiers , 86021, France
Saint-Herblain , 44805, France
Strasbourg , 67000, France
Berlin , 13353, Germany
Dresden , 01307, Germany
Hamburg , 20249, Germany
Hamburg , 22763, Germany
Koln , 50937, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Weiden , 92637, Germany
Catania , 95122, Italy
Faenza , 48018, Italy
Meldola , 47014, Italy
Naples , 80131, Italy
Orbassano , 10043, Italy
Piacenza , 29121, Italy
Pisa , 56126, Italy
Torino , 10126, Italy
Kashiwa Chiba, 100-0, Japan
Matsuyama Ehime, 791-0, Japan
Akashi Hyogo, 673-8, Japan
Kobe Hyogo, 650-0, Japan
Kawasaki Kanagawa, 216-8, Japan
Ikoma Nara, 630-0, Japan
Suita Osaka, 565-0, Japan
Ina Saitama, 362-0, Japan
Nagaizumi Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto-Ku Tokyo, 135-8, Japan
Akita , 010-8, Japan
Chiba , 260-8, Japan
Fukuoka , 811-1, Japan
Hiroshima , 734-8, Japan
Kagawa , 761-0, Japan
Kochi , 781-8, Japan
Kyoto , 606-8, Japan
Osaka , 541-8, Japan
Osaka , 569-8, Japan
Incheon , 21565, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 5505, Korea, Republic of
Seoul , 58128, Korea, Republic of
Seoul , 6351, Korea, Republic of
Seoul , 8308, Korea, Republic of
Barcelona Madrid, 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 08908, Spain
Madrid , 28006, Spain
Madrid , 28009, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Murcia , 30120, Spain
Zaragoza , 50009, Spain
Changhua NAP, 500-0, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 40447, Taiwan
Tainan , 710, Taiwan
Tainan , 73657, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
London , SE1 9, United Kingdom
London , SW17 , United Kingdom
London , SW3 6, United Kingdom
London , W12 0, United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Sutton , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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