Actively Recruiting
A Phase 3 Study of Tislelizumab by Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment for Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Led by BeOne Medicines · Updated on 2026-05-29
351
Participants Needed
93
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the levels of drug exposure in adults with locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma. This phase 3 study compares tislelizumab administered by subcutaneous injection versus intravenous infusion, both given as first-line therapy alongside chemotherapy. The study includes about 351 participants and aims to understand how these two methods of delivering tislelizumab differ in terms of drug concentration and patient outcomes. Participants are randomly assigned to one of two groups: one group receives tislelizumab 300 mg by subcutaneous injection on the first day of each 21-day cycle, followed by chemotherapy tailored to the patient; the other group receives tislelizumab 200 mg by intravenous infusion on the same schedule, also followed by individualized chemotherapy. The chemotherapy regimens may include drugs such as cisplatin, leucovorin, 5-fluorouracil, oxaliplatin, or capecitabine. The study consists of screening, treatment, and follow-up periods. During the study, participants will have tumor tissue collected for biomarker testing and regular assessments of tumor response, survival, and adverse events for up to two years. Researchers will measure drug levels in the blood at specific times, including trough concentrations and area under the curve, to compare the two administration methods. Safety and overall health will be monitored throughout the study and follow-up periods, which continue until April 2028.
CONDITIONS
Brief 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 (GEJ) 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 determined by investigator assessment
- Ability to provide tumor tissue samples for biomarker testing
- 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 the 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 the 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; stable, asymptomatic brain metastases without corticosteroid use for 4 weeks prior to randomization are allowed
- Gastric or GEJ adenocarcinoma positive for human epidermal growth factor receptor 2 (HER2)
- Active autoimmune diseases or history of autoimmune diseases that might relapse
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least weekly) or diuretics within 7 days before randomization
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive either subcutaneous or intravenous tislelizumab plus chemotherapy as first-line treatment for their unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
1 visit every 21 days for treatment administration
Duration - Up to 2 years
Participants are monitored for safety and effectiveness outcomes after treatment ends, including response, survival, and adverse events.
Periodic visits during follow-up as determined by the study
Trial Site Locations
Total: 93 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
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
17
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
18
Scott and White Memorial Hospital
Temple, Texas, United States, 76508-0001
Actively Recruiting
19
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
20
Hospital Aleman
CABA, Argentina, 1425
Actively Recruiting
21
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina, 1426
Actively Recruiting
22
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, Austria, 4010
Actively Recruiting
23
Medical Univeristy Vienna
Vienna, Austria, 1090
Actively Recruiting
24
Hospital de Amor Barretos
Barretos, Brazil, 14784-400
Actively Recruiting
25
CECAP
Blumenau, Brazil, 89035-510
Actively Recruiting
26
Hospital Brasilia
Brasília, Brazil, 71681-603
Actively Recruiting
27
Hospital Universiario Onofre Lopes
Natal, Brazil, 59012-300
Actively Recruiting
28
Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil, 90610-000
Actively Recruiting
29
IMIP
Recife, Brazil, 50070-902
Actively Recruiting
30
Inca Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Actively Recruiting
31
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
32
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Actively Recruiting
33
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil, 01401-004
Actively Recruiting
34
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil, 29043-260
Actively Recruiting
35
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
36
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
37
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
38
Anyang Tumor Hospital
Anyang, Henan, China, 455001
Actively Recruiting
39
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
40
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
41
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
42
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
43
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
44
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
45
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
46
Changzhi Peoples Hospital
Changzhi, Shanxi, China, 046099
Actively Recruiting
47
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
48
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
49
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
50
Masarykuv Onkologicky Ustav
Brno, Czechia, 602 00
Actively Recruiting
51
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 03
Actively Recruiting
52
Fakultni Nemocnice Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
53
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia, 10000
Actively Recruiting
54
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
55
Chru de Brest Hopital Cavale Blanche
Brest, France, 29200
Actively Recruiting
56
Hopital Claude Huriez Chu Lille
Lille, France, 59000
Actively Recruiting
57
Irccs Azienda Ospedaliera Metropolitana (Aom)
Genova, Italy, 16132
Actively Recruiting
58
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy, 20133
Actively Recruiting
59
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
60
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
61
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790 8524
Actively Recruiting
62
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, Japan, 806-0034
Actively Recruiting
63
Nho Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
64
Osaka Rosai Hospital
SakaiShi, Osaka, Japan, 591-8025
Actively Recruiting
65
Osaka Medical and Pharmaceutical University Hospital
Takatsukishi, Osaka, Japan, 569-8686
Actively Recruiting
66
Saitama Cancer Center
Kitaadachigun, Saitama, Japan, 362-0806
Actively Recruiting
67
Hamamatsu University School of Medicine, University Hospital
Hamamatsushi, Shizuoka, Japan, 431-3192
Actively Recruiting
68
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan, 320-0834
Actively Recruiting
69
Institute of Science Tokyo Hospital
Bunkyoku, Tokyo, Japan, 113-8519
Actively Recruiting
70
Tokyo Metropolitan Bokutoh Hospital
SumidaKu, Tokyo, Japan, 130-8575
Actively Recruiting
71
Health Pharma Professional Research Sa de Cv
Mexico City, Mexico, 03100
Actively Recruiting
72
Medical Care and Research Sa de Cv
Mérida, Mexico, 97070
Actively Recruiting
73
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Mexico, 68020
Actively Recruiting
74
Pratia McM Krakow
Krakow, Poland, 30-727
Actively Recruiting
75
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, Poland, 02-781
Actively Recruiting
76
Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
77
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Active, Not Recruiting
78
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, South Korea, 41404
Active, Not Recruiting
79
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Active, Not Recruiting
80
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Active, Not Recruiting
81
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Active, Not Recruiting
82
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Active, Not Recruiting
83
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
84
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
85
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
86
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
87
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye), 01060
Actively Recruiting
88
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
89
Acibadem Adana Hospital
Kuruköprü, Turkey (Türkiye), 01060
Actively Recruiting
90
Medical Park Florya Hospital
Sefaköy, Turkey (Türkiye), 34295
Actively Recruiting
91
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
92
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
93
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
Research Team
B
BeOne Medicines
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here