Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction 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: NCT03777657
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric, or Gastroesophageal Junction Adenocarcinoma Drug: Tislelizumab (BGB-A317) combined with oxaliplatin and capecitabine or Tislelizumab (BGB-A317) combined with Cisplatin and 5-FU Drug: Placebo combined with oxaliplatin and capecitabine or Placebo combined with Cisplatin and 5-FU Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab (BGB-A317) + chemotherapy
Patients received Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
Drug: Tislelizumab (BGB-A317) combined with oxaliplatin and capecitabine or Tislelizumab (BGB-A317) combined with Cisplatin and 5-FU
Tislelizumab (BGB-A317) + Oxaliplatin + Capecitabine: Subjects will be treated with BGB A317 200 mg IV on Day 1, cisplatin 80 mg/m² IV on Day 1, and 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21- day cycle. Tislelizumab (BGB-A317) + Cisplatin + 5- FU: Subjects will be treated with BGB A317 200 mg IV on Day 1, oxaliplatin 130 mg/m² IV on Day 1, and capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle.

Placebo Comparator: Placebo + chemotherapy
Patients receive placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
Drug: Placebo combined with oxaliplatin and capecitabine or Placebo combined with Cisplatin and 5-FU
Placebo + Oxaliplatin + Capecitabine: Subjects will be treated with Placebo 200 mg IV on Day 1, cisplatin 80 mg/m² IV on Day 1, and 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. Placebo + Cisplatin + 5-FU: Subjects will be treated with Placebo 200 mg IV on Day 1, oxaliplatin 130 mg/m² IV on Day 1, and capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle




Primary Outcome Measures :
  1. Progression-free survival - defined as the time from the date of randomization to the date of the first objectively documented tumor progression [ Time Frame: Up to 27 months ]
  2. Overall Survival - defined as the time from the date of randomization to the date of death due to any cause [ Time Frame: Up to 43 months ]

Secondary Outcome Measures :
  1. Overall response rate - defined as the proportion of patients whose best overall response is complete response or partial response per Response Evaluation Criteria in Solid Tumors v1.1 [ Time Frame: Up to 43 months ]
  2. Duration of response - defined as the time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first [ Time Frame: Up to 43 months ]
  3. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  4. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  5. Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  6. The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 [ Time Frame: Up to 43 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Able to provide written informed consent and can understand and comply with the requirements of the study
  2. Adult patients (≥ 18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent
  3. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
  4. At least 1 measurable lesion as defined per RECIST v1.1 as determined by investigator assessment.
  5. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
  6. Patients must be able to provide tumor tissues.
  7. ECOG PS ≤ 1 within 7 days prior to randomization
  8. Adequate organ function as indicated by the following laboratory values ≤ 7 days prior to randomization:
  9. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab or placebo and 180 days after the last dose of chemotherapy.
  10. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab or placebo and 180 days after the last dose of chemotherapy.

Exclusion Criteria:

  1. Patient has squamous cell or undifferentiated or other histological type GC
  2. Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.
  3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  4. Any active malignancy ≤ 2 years before randomization, with the exception of the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
  5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage within 7 days prior to randomization (The cytological confirmation of any effusion is permitted).
  6. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  7. Any condition that requires systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
  8. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc. NOTE: Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence. Patients with severe but stable radiation-induced pneumonitis may be required to undergo routine pulmonary function studies
  9. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
  10. A known history of HIV infection
  11. Patients with untreated chronic hepatitis B virus (HBV) or HBV carriers at screening or patients with active Hepatitis C virus (HCV) infection should be excluded.
  12. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  13. Prior allogeneic stem cell transplantation or organ transplantation
  14. A history of severe hypersensitivity reactions to other monoclonal antibodies or any components of study treatment
  15. Known dihydropyrimidine dehydrogenase (DPD) deficiency
  16. Underlying medical conditions or alcohol or drug abuse or dependence that, in the investigator's opinion, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or adverse events; or insufficient compliance during the study according to investigator's judgement.

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): NCT03777657


Contacts
Layout table for location contacts
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

  Hide Study Locations
Locations
Layout table for location information
United States, California
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
United States, Florida
Lynn Cancer Institute Center Recruiting
Boca Raton, Florida, United States, 33486
United States, Georgia
Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
United States, Illinois
Midwestern Regional Medical Center Not yet recruiting
Zion, Illinois, United States, 60099
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
United States, North Carolina
New Mexico Cancer Care Alliance/University of New Mexico Comprehensive Cancer Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Lineberger Cancer Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Wilmington Health Not yet recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cancer Treatment Centers of America Recruiting
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Thomas Jefferson University Hospital - Central Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29245
United States, Tennessee
Tennessee Oncology, PLLC - Nashville Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Scott & White Health Recruiting
Temple, Texas, United States, 76508
China, Anhui
The First Affiliated Hospital of Bengbu Medical College Not yet recruiting
Bengbu, Anhui, China, 233004
Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital Not yet recruiting
Hefei, Anhui, China, 230088
The Second Hospital of Anhui Medical Hospital Recruiting
Hefei, Anhui, China, 231200
China, Beijing
Beijing Chao Yang Hospital Recruiting
Beijing, Beijing, China, 100020
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100021
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100032
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
No. 3 Hospital, Beijing University Recruiting
Beijing, Beijing, China, 100083
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Chinese PLA General Hospital Medical School of Chinese PLA Recruiting
Beijing, Beijing, China, 100853
Beijing Luhe Hospital Recruiting
Beijing, Beijing, China, 101100
China, Fujian
The First Affiliated Hospital of Fujian Medical University Not yet recruiting
Fuzhou, Fujian, China, 350005
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
China, Guangdong
The First People's Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Sun Yat-sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510080
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
China, Guangxi
The 1st Affiliated Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
China, Hainan
Hainan General Hospital Not yet recruiting
Haikou, Hainan, China, 570311
China, Hebei
Fourth Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 50051
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
China, Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430023
Hubei Cancer Hospital Recruiting
Wuhan, Hubei, China, 430079
China, Hunan
Hunan Cancer Hospital Not yet recruiting
Changsha, Hunan, China, 410006
Xiangya Hospital Central South University Not yet recruiting
Changsha, Hunan, China, 410008
China, Jiangsu
The Affiliated Drum Tower Hospital of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210008
Jiangsu Cancer Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210009
Jiangsu Province Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210029
Nantong Tumor Hospital Not yet recruiting
Nantong, Jiangsu, China, 226361
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130000
China, Liaoning
The First Hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110001
General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 110016
Liaoning Cancer Hospital & Institute Recruiting
Shenyang, Liaoning, China, 110042
China, Shandong
Shandong Cancer Hospital Recruiting
Jinan, Shandong, China, 250117
Linyi Cancer Hospital Recruiting
Linyi, Shandong, China, 276001
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266071
China, Shanghai
Renji Hospital Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200001
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. Not yet recruiting
Shanghai, Shanghai, China, 200020
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 200080
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
China, Sichuan
Daping Hospital of The 3rd Military University Not yet recruiting
Chongqing, Sichuan, China, 400042
China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjin, Tianjin, China, 300060
China, Yunnan
Yunnan Cancer Hospital Not yet recruiting
Kunming, Yunnan, China, 650118
China, Zhejiang
The First Affiliated Hospital, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310003
The Second Affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
France
Centre Antoine Lacassagne Not yet recruiting
Nice cedex 02, Alpes Maritimes, France, 06189
Centre Paul Strauss Not yet recruiting
Strasbourg cedex, Bas Rhin, France, 67000
Centre Georges François Leclerc Not yet recruiting
Dijon cedex, Côte-d'Or, France, 21079
CHU Bordeaux - Hôpital Haut-Lévêque Not yet recruiting
Pessac, Gironde, France, 33604
ICO - Site René Gauducheau Not yet recruiting
Saint Herblain, Loire Atlantique, France, 44805
ICL - Alexis Vautrin Not yet recruiting
Vandœuvre-lès-Nancy cedex, Meurthe Et Moselle, France, 54519
Centre Oscar Lambret Not yet recruiting
Lille cedex, Nord, France, 59020
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Not yet recruiting
Torrette, Ancona, Italy, 60020
IRCCS Ospedale Casa Sollievo della Sofferenza Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
A.O Ospedali Riuniti Marche Nord Not yet recruiting
Pesaro, Pesaro - Urbino, Italy, 61121
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Not yet recruiting
Bologna, Italy, 40138
Istituto Nazionale Tumori Fondazione G. Pascale Not yet recruiting
Napoli, Italy, 80131
Università degli studi della Campania Luigi Vanvitelli Not yet recruiting
Napoli, Italy, 80131
IOV - Istituto Oncologico Veneto IRCCS Not yet recruiting
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Not yet recruiting
Roma, Italy, 133
Umberto I Pol. di Roma-Università di Roma La Sapienza Not yet recruiting
Roma, Italy, 161
A.O.U. Senese Policlinico Santa Maria alle Scotte Not yet recruiting
Siena, Italy, 53100
Azienda Ospedaliera Città della Salute e della Scienza di Torino Not yet recruiting
Torino, Italy, 10126
Japan
Chiba Cancer Center Recruiting
Chiba-shi, Chiba-Ken, Japan, 260-8717
NHO Kyushu Cancer Center Recruiting
Fukuoka-shi, Fukuoka-Ken, Japan, 811-1395
Hokkaido University Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8648
Kagawa University Hospital Recruiting
Kita-gun, Kagawa-Ken, Japan, 761-0793
Oita University Hospital Recruiting
Yufu-shi, Oita-Ken, Japan, 879-5593
Izumi City General Hospital Recruiting
Izumi-shi, Osaka-Fu, Japan, 594-0073
Saitama Cancer Center Recruiting
Ina, Saitama, Japan
Hamamatsu University School of Medicine, University Hospital Recruiting
Hamamatsu-shi, Shizuoka-Ken, Japan, 431-3192
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo-To, Japan, 104-0045
Cancer Institute Hospital of JFCR Recruiting
Koto-ku, Tokyo-To, Japan, 135-8550
Center Hospital of the National Center for Global Health and Medicine Recruiting
Shinjuku-ku, Tokyo-To, Japan, 162-8655
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Severance Hospital, Yonsei University Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 03722
The Catholic University of Korea, St. Vincent's Hospital Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
Ajou University Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Gyeongsangbuk-do, Korea, Republic of, 41404
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 2841
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 3080
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 5505
Poland
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdansk, Poland, 80-952
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna Not yet recruiting
Lodz, Poland, 90-242
Przychodnia Med-Polonia Sp. z o.o. Not yet recruiting
Poznan, Poland, 60-693
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Not yet recruiting
Warszawa, Poland, 02-034
Puerto Rico
Pan American Oncology Trials, LLC Recruiting
San Juan, Puerto Rico, 902
Romania
S.C Oncopremium Team S.R.L Not yet recruiting
Baia Mare, Romania, 430291
S.C Gral Medical S.R.L Not yet recruiting
Bucuresti, Romania, 31422
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca Not yet recruiting
Cluj-Napoca, Romania, 400015
Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Not yet recruiting
Constanta, Romania, 900591
S.C Centrul de Oncologie Sf. Nectarie S.R.L Not yet recruiting
Craiova, Romania, 200347
S.C Pelican Impex S.R.L Not yet recruiting
Oradea, Romania, 410469
S.C Oncomed S.R.L Not yet recruiting
Timisoara, Romania, 300239
Russian Federation
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" Not yet recruiting
Arkhangelsk, Russian Federation, 163045
RBIH "Ivanovo Regional Oncological Dispensary" Not yet recruiting
Ivanovo, Russian Federation, 153040
"VitaMed" LLC Not yet recruiting
Moscow, Russian Federation, 129515
BHI of Omsk region "Clinical Oncology Dispensary" Not yet recruiting
Omsk, Russian Federation, 644013
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)" Not yet recruiting
Pesochnyy, Russian Federation, 197758
SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary" Not yet recruiting
Pyatigorsk, Russian Federation, 357502
Private Educational Institution of Higher Education "Medical University "REAVIZ" Not yet recruiting
Samara, Russian Federation, 443011
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" Not yet recruiting
Yaroslavl, Russian Federation, 150054
Spain
ICO l'Hospitalet - Hospital Duran i Reynals Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 8908
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 8036
Hospital General Universitario Gregorio Marañon Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario HM Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Hospital Regional Universitario de Malaga Not yet recruiting
Málaga, Spain, 29010
Hospital Universitario Virgen del Rocio Not yet recruiting
Sevilla, Spain, 41013
Hospital Universitario Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Turkey
Acibadem Adana Hospital Not yet recruiting
Adana, Turkey, 1130
Baskent University Adana Application and Research Center Not yet recruiting
Adana, Turkey, 1220
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Not yet recruiting
Ankara, Turkey, 6105
Akdeniz University Medical Faculty Not yet recruiting
Antalya, Turkey, 7058
Dicle University Medical Faculty Not yet recruiting
Diyarbakir, Turkey, 21080
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Not yet recruiting
Istanbul, Turkey, 34098
Inonu Uni. Med. Fac. Not yet recruiting
Malatya, Turkey, 44280
Namik Kemal University Not yet recruiting
Tekirdag, Turkey, 59100
Karadeniz Tecnical Uni. Med. Fac. Not yet recruiting
Trabzon, Turkey, 61100
Sponsors and Collaborators
BeiGene
Investigators
Layout table for investigator information
Principal Investigator: Crystal Denlinger, MD Fox Chase Cancer Center

Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03777657     History of Changes
Other Study ID Numbers: BGB-A317-305
2018-000312-24 ( EudraCT Number )
CTR20181841 ( Registry Identifier: Center for drug evaluation, CFDA )
JapicCTI-194799 ( Registry Identifier: Japic )
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Esophageal Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Cisplatin
Capecitabine
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs