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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783442
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in patients with advanced unresectable/metastatic ESCC.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU) Drug: Platinum (cisplatin or oxaliplatin) + capecitabine Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Tislelizumab + chemotherapy
Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • 5-FU 750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • Capecitabine 1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 or 2 Q3W

    • Depending on local guidelines, cisplatin may be given in 3 divided doses on Days 1, 2, and 3. The total dose given must be between 60 to 80 mg/m2 per cycle.
  • Paclitaxel 175 mg/m2 IV on Day 1 Q3W

Active Comparator: Arm B
Placebo + chemotherapy
Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • 5-FU 750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • Capecitabine 1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 or 2 Q3W

    • Depending on local guidelines, cisplatin may be given in 3 divided doses on Days 1, 2, and 3. The total dose given must be between 60 to 80 mg/m2 per cycle.
  • Paclitaxel 175 mg/m2 IV on Day 1 Q3W




Primary Outcome Measures :
  1. PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  2. OS - defined as the time from the date of randomization until the date of death due to any cause [ Time Frame: Approximately 31 months from date of the first patient randomization ]

Other Outcome Measures:
  1. ORR - defined as the proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by BIRC per RECIST v1.1 [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  2. DOR- defined as the time from the first determination of an objective response until the first documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes first [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  3. Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  4. Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  5. Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using the generic health state instrument European Quality of Life- 5 Dimensions (EuroQol 5D EQ-5D-5L). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  6. The incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 [ Time Frame: Approximately 31 months from date of the first patient randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy, chemo-radiation therapy or surgery) was given.

Inclusion Criteria:

  1. Pathologically (histologically) confirmed diagnosis of ESCC
  2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease with a treatment free interval of at least 6 months after definitive treatment.

Exclusion Criteria:

  1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  3. Received prior therapies targeting PD-1, PD-L1 or PD-L2
  4. Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  5. 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)
  6. Evidence of complete esophageal obstruction not amenable to treatment
  7. Unintentional weight loss ≥ 5% within one month prior to randomization or other indicators of severe malnutrition (Severe malnutrition may be determined using the Nutritional Risk Index (Shirasu, et al. 2018))
  8. Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have peripheral neuropathy ≥ Grade 2 at baseline
  9. Patients who recur after definitive surgery and are eligible for non-palliative radiation therapy and/or chemoradiotherapy.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783442


Contacts
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Contact: BeiGene 1 (877) 828-5568 clinicaltrials@beigene.com

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Locations
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United States, Connecticut
Smilow Cancer Hospital at Yale-New Haven - Neurology Recruiting
New Haven, Connecticut, United States, 06510-3220
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Allegheny General Hospital (AGH) Recruiting
Pittsburgh, Pennsylvania, United States, 15212-4756
United States, South Carolina
Medical University of South Carolina Hollings Cancer Center Not yet recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Health Science Center of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77389
Australia, Pacific Highway
Coffs Harbour Hospital Recruiting
Coffs Harbour, Pacific Highway, Australia, 2450
Australia, Queensland
Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 6008
Australia, Tasmania
Royal Hobart Hospital Not yet recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
St Vincent's Hospital Recruiting
Fitzroy, Victoria, Australia, 3065
Ballarat Oncology & Haematology Services Not yet recruiting
Wendouree, Victoria, Australia, 3355
Belgium
UZ Antwerpen - Oncologie Recruiting
Edegem, Antwerpen, Belgium, 2650
Institut Jules Bordet - Oncologie Médicale Recruiting
Brussels, Brussels Capital Region, Belgium, 1000
Grand Hôpital de Charleroi - Site Notre-Dame Recruiting
Charleroi, Hainaut, Belgium, 6000
UZ Gent - Radiologie Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
UZ Leuven - Campus Gasthuisberg Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
CHC Clinique Saint-Joseph Recruiting
Liège, Belgium, 4000
CHU de Liège - Domaine Universitaire du Sart Tilman Recruiting
Liège, Belgium, 4000
China, Anhui
Anhui Provincial Cancer Hospital Recruiting
Hefei, Anhui, China, 230088
Anhui Medical University - The Second Hospital Recruiting
Hefei, Anhui, China, 230601
China, Beijing
Beijing Friendship Hospital - Oncology Recruiting
Beijing, Beijing, China, 100050
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Peking Union Medical College Hospital - Oncology Not yet recruiting
Beijing, Beijing, China, 100730
China, Fujian
Fujian Provincial Cancer Hospital - Oncology Recruiting
Fuzhou, Fujian, China, 350014
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 35005
Zhongshan Hospital Xiamen University Recruiting
Xiamen, Fujian, China, 361004
China, Guangdong
The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology Recruiting
Guangzhou, Guangdong, China, 510000
The Sixth Affiliated Hospital ,Sun Yat-Sen University - Oncology Recruiting
Guangzhou, Guangdong, China, 510000
Guangdong Province Traditional Chinese Medical Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Cancer Hospital of Shantou University Medical College Recruiting
Shantou, Guangdong, China, 515031
China, Guangxi
Guangxi Medical University Affiliated tumor hospital Recruiting
Nanning, Guangxi, China
China, Hainan
Hainan General Hospital - Oncology Recruiting
Haikou, Hainan, China
China, Heilongjiang
Harbin Medical University Cancer Hospital - Oncology Recruiting
Haerbin, Heilongjiang, China, 150081
China, Henan
The First Affiliated Hospital of Zhengzhou University - Oncology Recruiting
Henan, Henan, China, 450052
The First Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, Henan, China, 453100
Henan Cancer Hospital - Oncology Recruiting
Zhengzhou, Henan, China, 450008
China, Hubei
Hubei Cancer Hospital - Oncology Recruiting
Wuhan, Hubei, China, 400037
Xiangyang Central Hospital Recruiting
Xiangyang, Hubei, China, 441000
China, Hunan
Hunan Cancer Hospital - GCP Office Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
The First People's Hospital of Changzhou - Oncology Recruiting
Changzhou, Jiangsu, China, 213003
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Nantong Tumor Hospital - Medical Oncology Recruiting
Nantong, Jiangsu, China
Wuxi Fourth People's Hospital - Oncology Recruiting
Wuxi, Jiangsu, China, 214062
The Affiliated Hospital of Xuzhou Medical University - Radiology Recruiting
Xuzhou, Jiangsu, China
Subei People's Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
China, Liaoning
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology Recruiting
Shenyang, Liaoning, China, 110017
China, Quanzhou
Quanzhou First Hospital - Radiotherapy/Nuclear Medicine Recruiting
Quanzhou, Quanzhou, China
China, Shandong
Shandong Cancer Hospital - oncology - Oncology Recruiting
Jinan, Shandong, China
Shandong Linyi Tumor Hospital Recruiting
Linyi, Shandong, China, 276001
WeiFang People's Hospital Recruiting
Weifang, Shandong, China
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China
China, Shanxi
Shanxi Provincial People's Hospital Recruiting
Taiyuan, Shanxi, China
China, Tianjin
Tianjin Cancer Hospital - Gastroinstinal Oncology Recruiting
Tianjin, Tianjin, China, 300060
China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Sir Run Run Shaw Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
China
The First Affiliated Hospital, Sun Yat-Sen University - Alliance Member Recruiting
Guangzhou, China
Anhui Provincial Hospital - Oncology Recruiting
Hefei, China, 230001
The First Affiliated Hospital of Xiamen University - Oncology Recruiting
Xiamen, China, 361005
Czechia
Fakultní Nemocnice Olomouc Not yet recruiting
Olomouc, Czechia, 779 00
Thomayerova nemocnice Recruiting
Praha 4, Czechia, 140 59
Nemocnice Na Bulovce Recruiting
Praha 8, Czechia, 180 81
France
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie Recruiting
Brest Cedex, Bretagne, France, 29609
CHU De Besançon-Jean Minjoz - Oncologie Médicale Recruiting
Besançon Cedex, Doubs, France, 25030
CHU Bordeaux Hôpital Du Haut-Lévêque Recruiting
Pessac, Gironde, France, 33604
Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber Recruiting
Levallois-Perret, Hauts-de-Seine, France, 92300
ICO Recruiting
Saint-Herblain, Loire-Atlantique, France, 44805
Center Oscar Lambret - Alliance Member Not yet recruiting
Lille, Nord, France, 59000
Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie Recruiting
Paris Cedex 12, Paris, France, 75012
Centre Léon Bérard Not yet recruiting
Lyon, Rhône, France, 69373
Hospital of Poitiers Recruiting
Poitiers, Vienne, France, 86021
Hopital Europeen Georges Pompidou - Digestive Oncology Recruiting
Paris, France, 75015
Groupe Hospitalier Paris Saint Joseph - Oncologie Recruiting
Paris, France, 75074
Germany
SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin Recruiting
Heilbronn, Baden-Württemberg, Germany, 74078
Medizinische Universitaetsklinik Not yet recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Johannes Wesling Klinikum Minden Not yet recruiting
Minden, Nordrhein-Westfalen, Germany, 32429
Universitätsmedizin Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55101
Universitätsklinikum Leipzig Not yet recruiting
Leipzig, Saarland, Germany, 4103
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica Not yet recruiting
Ancona, Italy, 60126
Irccs Irst Recruiting
Meldola, Italy, 47014
Ieo, Irccs Recruiting
Milano, Italy, 20141
Ospedale Niguarda Ca' Granda Recruiting
Milano, Italy, 20162
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori Recruiting
Napoli, Italy, 80131
Istituto Oncologico Veneto IOV-IRCCS Not yet recruiting
Padova, Italy, 35128
SO S.Chiara, AOU Pisana - Oncologia 2 Not yet recruiting
Pisa, Italy, 56126
AOU Città della Salute e della Scienza di Torino - Molinette Not yet recruiting
Torino, Italy, 10126
Japan
National Cancer Center Hospital East - Gastrointestinal Oncology Recruiting
Kashiwa, Chiba, Japan, 104-0045
Kyushu Medical Center - Gastroenterological Surgery Recruiting
Fukuoka, Hukuoka, Japan, 810-8563
National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology Not yet recruiting
Fukuoka, Hukuoka, Japan, 811-1395
Kobe University Hospital - Gastroenterology Not yet recruiting
Kobe, Hyogo, Japan, 650-0017
Kobe City Medical Center General Hospital - Medical Oncology Recruiting
Kobe, Hyogo, Japan, 650-0047
Kagawa University Hospital - Oncology Recruiting
Kita-gun, Kagawa, Japan, 761-0793
Kanagawa Cancer Center - Gastroenterological surgery Recruiting
Yokohama, Kanagawa, Japan, 241-8515
University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology Recruiting
Kamigyō-ku, Kyoto, Japan, 602-8566
Osaka International Cancer Institute - Clinical Oncology Recruiting
Higashinari-ku, Osaka, Japan, 537-8511
Kindai University Nara Hospital Recruiting
Ikoma, Osaka, Japan, 630-0293
Osaka University Hospital - Medical Oncology Recruiting
Suita, Osaka, Japan, 565-0871
Saitama Cancer Center - Gastroenterology Recruiting
Kitaadachi-gun, Saitama, Japan, 362-0806
National Cancer Center Hospital - Gastrointestinal Oncology Not yet recruiting
Chuo Ku, Tokyo, Japan, 104-0045
Hyogo Cancer Center Not yet recruiting
Akashi, Japan, 673-8558
Akita University Hospital - Pediatrics Not yet recruiting
Akita-shi, Japan, 010-8543
Kansai Rosai Hospital - Gastroenterological Surgery Recruiting
Amagasaki, Japan, 660-8511
Hiroshima University Hospital - Gastrointestinal Surgery Recruiting
Hiroshima, Japan, 734-8551
Kumamoto University Hospital Not yet recruiting
Kumamoto, Japan, 860-8556
Kyoto University Hospital Not yet recruiting
Kyoto, Japan, 606-8507
Niigata Cancer Center Hospital Not yet recruiting
Niigata, Japan, 951-8566
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Daegu Gwang'yeogsi [Taegu-Kwan, Korea, Republic of, 41931
Seoul National University Bundang Hospital - Hematology/Oncology Not yet recruiting
Seongnam-si, Gyeonggido [Kyonggi-do], Korea, Republic of, 13620
CHA Bundang Medical Center, CHA University - Oncology Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Gachon University Gil Medical Center - Oncology Recruiting
Incheon, Incheon Gwang'yeogsi [Inch'n-K, Korea, Republic of, 21565
Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic Recruiting
Jeollanam-do, Jeonranamdo [Chollanam-do], Korea, Republic of, 58128
Samsung Medical Center - Hematology-Oncology Recruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06351
SMG-SNU Boramae Medical Center - Oncology Recruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 07061
Korea University Guro Hospital - Hematology-Oncology Recruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 08308
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 137-701
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 42601
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Poland
Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Recruiting
Warszawa, Mazowieckie, Poland, 02-034
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi Recruiting
Brzozow, Podkarpackie, Poland, 36-200
Szpital Wojewodzki w Koszalinie Recruiting
Koszalin, Pomorskie, Poland, 75-581
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Recruiting
Olsztyn, Warminsko-mazurskie, Poland, 10-228
Clinical Research Center Sp. z o.o., Medic-R Sp. K. Recruiting
Poznan, Wielkopolskie, Poland, 60-848
Romania
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca Not yet recruiting
Cluj-Napoca, Cluj, Romania, 400015
Radiotherapy Center Cluj Not yet recruiting
Floreşti, Cluj, Romania, 407280
Centrul de Oncologie Sf. Nectarie Not yet recruiting
Craiova, Dolj, Romania, 200347
Institutul Clinic Fundeni Not yet recruiting
Bucuresti, Romania, 022328
Spitalul Clinic Coltea Not yet recruiting
Bucuresti, Romania, 030171
Medisprof Not yet recruiting
Cluj-Napoca, Romania, 400641
Centrul de Oncologie Euroclinic Not yet recruiting
Iaşi, Romania, 700106
Russian Federation
Arkhangelsk Regional Clinical Oncological Dispensary Recruiting
Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045
Leningrad Regional Oncology Dispensary Not yet recruiting
Kuz'molovskiy, Leningradskaya Oblast, Russian Federation, 188663
Orenburg Regional Clinical Oncology Center Recruiting
Orenburg, Orenburgskaya Oblast, Russian Federation, 460021
Rostov Research Institute of Oncology (RRIO) Recruiting
Rostov-Na-Donu, Rostovskaya Oblast, Russian Federation, 344037
The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov Not yet recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 194291
City Oncology Dispensary Not yet recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153015
Russian Academy of Medical Sciences (RAMS) Not yet recruiting
Moscow, Russian Federation, 115478
Petrov Research Institute of Oncology Not yet recruiting
Saint Petersburg, Russian Federation, 197758
Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Institut Catalá d´Oncología (I.C.O.) Not yet recruiting
L'Hospitalet De Llobregat, Barcelona, Spain, 08907
Hospital Madrid Norte Sanchinarro Recruiting
Sanchinarro, Madrid, Spain, 28050
Hospital Universitario Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28009
H.U.V.Arrixaca Not yet recruiting
Murcia, Spain, 30120
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29010
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Taiwan
Kaohsiung Veterans General Hospital - Thoracic Surgery Recruiting
Kaohsiung, Taiwan, 813
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology Recruiting
Kaohsiung, Taiwan, 833
China Medical University Hospital - Oncology - Taichung Recruiting
Taichung, Taiwan, 40447
Chi Mei Medical Center - YongKang - Chi Mei Medical Center Recruiting
Tainan, Taiwan, 71004
Chi Mei Hospital, Liouying - Department of Oncology Recruiting
Tainan, Taiwan, 73657
United Kingdom
Guys and St Thomas' Hospital Not yet recruiting
London, City Of London, United Kingdom, SE1 9RT
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi Not yet recruiting
London, City Of London, United Kingdom, SW3 6JJ
Mount Vernon Cancer Centre Recruiting
Northwood, England, United Kingdom, HA6 2RN
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Beatson West of Scotland Cancer Centre - Oncology Not yet recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
The Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom, LS9 7TF
The Christie NHS Foundation Trust - Oak Road Treatment Centr Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Virginia Paton, Pharm.D. BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03783442     History of Changes
Other Study ID Numbers: BGB-A317-306
2018-000587-28 ( EudraCT Number )
CTR20181013 ( Other Identifier: Center for drug evaluation, CFDA )
JapicCTI-194741 ( Registry Identifier: Japic )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Esophageal Diseases
Carcinoma
Carcinoma, Squamous Cell
Digestive System Diseases
Gastrointestinal Diseases
Paclitaxel
Cisplatin
Capecitabine
Oxaliplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors