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A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: BeOne Medicines
Summary
This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.
Official title: A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
351
Start Date
2025-08-27
Completion Date
2028-04-22
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Subcutaneous Tislelizumab
Administered by subcutaneous injection
Intravenous Tislelizumab
Administered by intravenous infusion
Cisplatin
Administered by intravenous infusion
Leucovorin
Administered by intravenous infusion
5-fluorouracil (5-FU)
Administered by intravenous infusion
Oxaliplatin
Administered by intravenous infusion
Capecitabine
Administered orally
Locations (78)
Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, United States
Orlando Health Ufhealth Cancer Center
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
New England Cancer Specialists
Westbrook, Maine, United States
St Louis Cancer Care, Llp
Bridgeton, Missouri, United States
Nebraska Hematology Oncology
Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Md Anderson Cancer Center
Houston, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, Austria
Hospital de Amor Barretos
Barretos, Brazil
CECAP
Blumenau, Brazil
Hospital Brasilia
Brasília, Brazil
Hospital Universiario Onofre Lopes
Natal, Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil
IMIP
Recife, Brazil
Inca Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Anyang Tumor Hospital
Anyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
Ganzhou, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Changzhi Peoples Hospital
Changzhi, Shanxi, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Masarykuv Onkologicky Ustav
Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Institut Sainte Catherine
Avignon, France
Chru de Brest Hopital Cavale Blanche
Brest, France
Hopital Claude Huriez Chu Lille
Lille, France
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, Japan
Nho Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Osaka Rosai Hospital
SakaiShi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsukishi, Osaka, Japan
Saitama Cancer Center
Kitaadachigun, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Institute of Science Tokyo Hospital
Bunkyoku, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
SumidaKu, Tokyo, Japan
Pratia McM Krakow
Krakow, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, Poland
Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
Ninewells Hospital and Medical School
Dundee, United Kingdom