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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

StatusRecruiting
PhasePhase 3
Started2025-08-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v28
Study sites95 entries, revised
The University of Texas Md Anderson Cancer Center
2026-08-21
Study Status, Contacts/Locations v27
Study sitesdetails revised at 1 of 95 sites
2026-08-06
Study Status, Contacts/Locations v26
Study sites95 entries, revised
NhoNational Hospital Organization Hokkaido Cancer Center
2026-07-21
Study Status, Contacts/Locations v25
Study sites94→95
2026-06-18
Study Status, Contacts/Locations v24
Study sites93→94
2026-05-28
Study Status, Contacts/Locations v23
Trial sites expanded: 86 → 93 locations
2026-05-08
Study Status, Contacts/Locations v22
Study sites85→86
2026-04-21
Study Status, Contacts/Locations v21
Trial sites expanded: 82 → 85 locations
2026-04-15
Study Status, Contacts/Locations v20
Trial sites expanded: 78 → 82 locations
2026-03-18
Study Status, Contacts/Locations v19
Study sites75→78
2026-03-03
Study Status, Contacts/Locations v18
Study sites69→75
2026-02-19
Study Status, Contacts/Locations v17
Study sites65→69
2026-02-09
Study Status, Contacts/Locations v16
Study sites60→65
2026-01-21
Study Status, Contacts/Locations v15
Study sites51→60
2026-01-15
Study Status, Contacts/Locations v14
Study sites44→51
2026-01-05
Study Status, Study Description, Contacts/Locations v13
Study sites37→44
Study description+209 characters
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
2025-12-15
Study Status, Contacts/Locations v12
Study sites32→37
2025-11-20
Study Status, Contacts/Locations v11
Study sites28→32
2025-11-11
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v10
Study sites21→28
Lead sponsorBeiGene→BeOne Medicines
2025-10-23
Study Identification, Study Status, Contacts/Locations v9
Study sites95→21
2025-09-23
Study Status, Contacts/Locations v8
Study sites96→95
2025-09-12
Study Status, Contacts/Locations v7
Study sites95→96
2025-09-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-08-27
Study sitesdetails revised at 95 of 95 sites
2025-08-19
Study Status v5
Re-verified, no change to tracked fields
2025-08-05
Study Status, Contacts/Locations v4
Study sites97→95
2025-07-24
Study Status v3
Re-verified, no change to tracked fields
2025-07-17
Study Status, Contacts/Locations v2
Study sites87→97
2025-07-07
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2025-06-20
Original filing
BeOne Medicines
59 trials monitored
See 7 trials at risk
Gastric Cancer
1,194 trials monitored
See 60 trials at risk
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.
Trial Details
NCT Number NCT07043400
Lead Sponsor BeOne Medicines
Conditions Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 351 participants
Start Date 2025-08-27
Primary Completion 2027-10-30 (estimated)
Study Completion 2028-04-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-14