Actively Recruiting
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
Led by BeOne Medicines · Updated on 2026-05-11
351
Participants Needed
86
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- No previous systemic therapy for locally advanced unresectable or metastatic gastric or GEJ cancer
- At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as assessed by investigator
- Ability to provide tumor tissues for biomarker assessment
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Adequate organ function
- Women of childbearing potential must agree to use highly effective birth control during the study and for at least 120 days after last dose of tislelizumab
- Non-sterile males must agree to use highly effective birth control during the study and for at least 120 days after last dose of tislelizumab
You will not qualify if you...
- Squamous cell, undifferentiated, or other histological types of gastric cancer
- Active leptomeningeal disease or uncontrolled brain metastasis (except stable, asymptomatic brain metastases without corticosteroids for at least 4 weeks before randomization)
- Gastric or GEJ adenocarcinoma positive for human epidermal growth factor receptor 2 (HER2)
- Active or history of autoimmune diseases that may relapse
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or diuretics within 7 days prior to randomization
- Other protocol-defined inclusion and exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224-5665
Actively Recruiting
2
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
3
UC Health Cancer Care and Hematology Clinic Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
4
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, United States, 33013-3804
Actively Recruiting
5
Orlando Health Ufhealth Cancer Center
Orlando, Florida, United States, 32806-2134
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521-0509
Actively Recruiting
8
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160-8500
Actively Recruiting
9
New England Cancer Specialists
Westbrook, Maine, United States, 04092
Actively Recruiting
10
St Louis Cancer Care, Llp
Bridgeton, Missouri, United States, 63044
Actively Recruiting
11
Nebraska Hematology Oncology
Lincoln, Nebraska, United States, 68506-7548
Actively Recruiting
12
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169-3321
Actively Recruiting
13
Hunterdon Hematology Oncology
Flemington, New Jersey, United States, 08822-4603
Actively Recruiting
14
Summit Medical Group
Florham Park, New Jersey, United States, 07932-1049
Actively Recruiting
15
Oregon Oncology Specialists
Salem, Oregon, United States, 97301
Actively Recruiting
16
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
17
Scott and White Memorial Hospital
Temple, Texas, United States, 76508-0001
Actively Recruiting
18
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
19
Hospital Aleman
CABA, Argentina, 1425
Actively Recruiting
20
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, Austria, 4010
Actively Recruiting
21
Medical Univeristy Vienna
Vienna, Austria, 1090
Actively Recruiting
22
Hospital de Amor Barretos
Barretos, Brazil, 14784-400
Actively Recruiting
23
CECAP
Blumenau, Brazil, 89035-510
Actively Recruiting
24
Hospital Brasilia
Brasília, Brazil, 71681-603
Actively Recruiting
25
Hospital Universiario Onofre Lopes
Natal, Brazil, 59012-300
Actively Recruiting
26
Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil, 90610-000
Actively Recruiting
27
IMIP
Recife, Brazil, 50070-902
Actively Recruiting
28
Inca Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Actively Recruiting
29
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
30
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Actively Recruiting
31
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil, 01401-004
Actively Recruiting
32
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil, 29043-260
Actively Recruiting
33
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
34
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
35
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
36
Anyang Tumor Hospital
Anyang, Henan, China, 455001
Actively Recruiting
37
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
38
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
39
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
40
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
41
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
42
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
43
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
44
Changzhi Peoples Hospital
Changzhi, Shanxi, China, 046099
Actively Recruiting
45
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
46
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
47
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
48
Masarykuv Onkologicky Ustav
Brno, Czechia, 602 00
Actively Recruiting
49
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 03
Actively Recruiting
50
Fakultni Nemocnice Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
51
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia, 10000
Actively Recruiting
52
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
53
Chru de Brest Hopital Cavale Blanche
Brest, France, 29200
Actively Recruiting
54
Hopital Claude Huriez Chu Lille
Lille, France, 59000
Actively Recruiting
55
Irccs Azienda Ospedaliera Metropolitana (Aom)
Genova, Italy, 16132
Actively Recruiting
56
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy, 20133
Actively Recruiting
57
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
58
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
59
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790 8524
Actively Recruiting
60
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, Japan, 806-0034
Actively Recruiting
61
Nho Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
62
Osaka Rosai Hospital
SakaiShi, Osaka, Japan, 591-8025
Actively Recruiting
63
Osaka Medical and Pharmaceutical University Hospital
Takatsukishi, Osaka, Japan, 569-8686
Actively Recruiting
64
Saitama Cancer Center
Kitaadachigun, Saitama, Japan, 362-0806
Actively Recruiting
65
Hamamatsu University School of Medicine, University Hospital
Hamamatsushi, Shizuoka, Japan, 431-3192
Actively Recruiting
66
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan, 320-0834
Actively Recruiting
67
Institute of Science Tokyo Hospital
Bunkyoku, Tokyo, Japan, 113-8519
Actively Recruiting
68
Tokyo Metropolitan Bokutoh Hospital
SumidaKu, Tokyo, Japan, 130-8575
Actively Recruiting
69
Pratia McM Krakow
Krakow, Poland, 30-727
Actively Recruiting
70
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, Poland, 02-781
Actively Recruiting
71
Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
72
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Active, Not Recruiting
73
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, South Korea, 41404
Active, Not Recruiting
74
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Active, Not Recruiting
75
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Active, Not Recruiting
76
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Active, Not Recruiting
77
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Active, Not Recruiting
78
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
79
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
80
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
81
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
82
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye), 01060
Actively Recruiting
83
Acibadem Adana Hospital
Kuruköprü, Turkey (Türkiye), 01060
Actively Recruiting
84
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
85
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
86
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
Research Team
B
BeOne Medicines
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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