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).
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.
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There are 150 Locations for this study
New Haven Connecticut, 06510, United States
Detroit Michigan, 48201, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29425, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77389, United States
Coffs Harbour Pacific Highway, 2450, Australia
Douglas Queensland, 4814, Australia
Kurralta Park South Australia, 6008, Australia
Hobart Tasmania, 7000, Australia
Fitzroy Victoria, 3065, Australia
Wendouree Victoria, 3355, Australia
Edegem Antwerpen, 2650, Belgium
Anderlecht Brussels Capital Region, 1070, Belgium
Charleroi Hainaut, 6000, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Brugge West-Vlaanderen, 8000, Belgium
Liège , 4000, Belgium
Liège , 4000, Belgium
Hefei Anhui, 23008, China
Hefei Anhui, 23060, China
Hefei Anhui, 23060, China
Beijing Beijing, 10005, China
Beijing Beijing, 10007, China
Beijing Beijing, 10008, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35001, China
Fuzhou Fujian, 35005, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51000, China
Guangzhou Guangdong, 51012, China
Guangzhou Guangdong, 51065, China
Shantou Guangdong, 51503, China
Nanning Guangxi, , China
Haikou Hainan, , China
Haerbin Heilongjiang, 15008, China
Henan Henan, 45005, China
Xinxiang Henan, 45310, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43007, China
Xiangyang Hubei, 44102, China
Changsha Hunan, 41001, China
Changzhou Jiangsu, 21300, China
Nanjing Jiangsu, 21002, China
Nantong Jiangsu, , China
Wuxi Jiangsu, 21406, China
Xuzhou Jiangsu, , China
Yangzhou Jiangsu, 22500, China
Nanchang Jiangxi, 33000, China
Shenyang Liaoning, 11001, China
Quanzhou Quanzhou, , China
Jinan Shandong, 25011, China
Linyi Shandong, 27600, China
Weifang Shandong, , China
Shanghai Shanghai, , China
Taiyuan Shanxi, , China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Hefei , 23000, China
Xiamen , 36100, China
Olomouc , 779 0, Czechia
Praha 4 , 140 5, Czechia
Praha 8 , 180 8, Czechia
Brest Cedex Bretagne, 29609, France
Besançon Cedex Doubs, 25030, France
Pessac Cedex Gironde, 33608, France
Levallois-Perret Hauts-de-Seine, 92300, France
Saint-Herblain Loire-Atlantique, 44805, France
Lille Nord, 59000, France
Paris Cedex 12 Paris, 75571, France
Lyon Rhône, 69008, France
Poitiers Vienne, 86000, France
Paris , 75015, France
Paris , 75074, France
Heilbronn Baden-Württemberg, 74078, Germany
Tuebingen Baden-Württemberg, 72076, Germany
Minden Nordrhein-Westfalen, 32429, Germany
Mainz Rheinland-Pfalz, 55101, Germany
Leipzig Sachsen, 04103, Germany
Hamburg , 20251, Germany
Torino Ancona, 60126, Italy
Meldola Emilia-Romagna, 47014, Italy
Ancona , 60126, Italy
Milano , 20141, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pisa , 56126, Italy
Kashiwa Chiba, 277-8, Japan
Fukuoka Hukuoka, 810-8, Japan
Fukuoka Hukuoka, 811-1, Japan
Kobe Hyogo, 650-0, Japan
Kita-gun Kagawa, 761-0, Japan
Yokohama Kanagawa, 241-8, Japan
Kamigyō-ku Kyoto, 602-8, Japan
Ikoma Osaka, 630-0, Japan
Suita Osaka, 565-0, Japan
Chuo Ku Tokyo, 104-0, Japan
Akashi , 673-8, Japan
Akita-shi , 010-8, Japan
Amagasaki , 660-8, Japan
Hiroshima , 734-8, Japan
Kumamoto , 860-8, Japan
Kyoto , 606-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Saitama , 362-0, Japan
Seongnam-si Gyeonggido [Kyonggi-do], 13620, Korea, Republic of
Seongnam-si Gyeonggido, 13496, Korea, Republic of
Incheon Incheon Gwang'yeogsi [Inch'n-K, 21565, Korea, Republic of
Hwasun Jeonranamdo [Chollanam-do], 58128, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp], 6591, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 06351, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 07061, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 08308, Korea, Republic of
Daegu , 42601, Korea, Republic of
Seoul , 05505, Korea, Republic of
Warszawa Mazowieckie, 02-03, Poland
Brzozow Podkarpackie, 36-20, Poland
Koszalin Pomorskie, 75-58, Poland
Olsztyn Warminsko-mazurskie, 10-22, Poland
Poznan Wielkopolskie, 60-84, Poland
Cluj-Napoca Cluj, 40001, Romania
Floreşti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Bucuresti , 02232, Romania
Bucuresti , 03017, Romania
Cluj-Napoca , 40064, Romania
Iaşi , 70010, Romania
Arkhangelsk Arkhangel'skaya Oblast', 16304, Russian Federation
Kuz'molovskiy Leningradskaya Oblast, 18866, Russian Federation
Orenburg Orenburgskaya Oblast, 46002, Russian Federation
Rostov-Na-Donu Rostovskaya Oblast, 34403, Russian Federation
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Ivanovo , 15301, Russian Federation
Saint Petersburg , 19775, Russian Federation
Oviedo Asturias, 33011, Spain
L'Hospitalet De Llobregat Barcelona, 08907, Spain
Sanchinarro Madrid, 28050, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Murcia , 30120, Spain
Málaga , 29010, Spain
Zaragoza , 50009, Spain
Kaohsiung , 813, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 40447, Taiwan
Tainan , 71004, Taiwan
Tainan , 73657, Taiwan
London City Of London, SE1 9, United Kingdom
London City Of London, SM2 5, United Kingdom
London City Of London, SW3 6, United Kingdom
Northwood England, HA6 2, United Kingdom
Maidstone Kent, ME16 , United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Manchester , M20 4, United Kingdom
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