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
NCT ID: NCT07043400
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
351 participants
INTERVENTIONAL
2025-08-27
2028-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Tislelizumab Subcutaneous + Chemotherapy
Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
Subcutaneous Tislelizumab
Administered by subcutaneous injection
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
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy
Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
* Must be able to provide tumor tissues for biomarker assessment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
* Adequate organ function.
* Women of childbearing potential 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.
* 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.
Exclusion Criteria
* 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.
* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
* Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Summit Medical Group
Florham Park, New Jersey, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Northwest Medical Specialties
Tacoma, Washington, United States
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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
Shandong Cancer Hospital
Jinan, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, Japan
Nho Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsukishi, Osaka, Japan
Saitama Cancer Center
Kitaadachigun, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Tokyo Metropolitan Bokutoh Hospital
SumidaKu, Tokyo, Japan
Institute of Science Tokyo Hospital
Tokyo, , Japan
Pan American Oncology Trials, Llc
Rio Piedras, , Puerto Rico
Seoul National University Bundang Hospital
BundangGu SeongnamSi, 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
Countries
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Central Contacts
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Other Identifiers
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2025-522862-58-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-A317-316
Identifier Type: -
Identifier Source: org_study_id