Trials / Recruiting
RecruitingNCT07043400
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
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 351 (estimated)
- Sponsor
- BeOne Medicines · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Subcutaneous Tislelizumab | Administered by subcutaneous injection |
| DRUG | Intravenous Tislelizumab | Administered by intravenous infusion |
| DRUG | Cisplatin | Administered by intravenous infusion |
| DRUG | Leucovorin | Administered by intravenous infusion |
| DRUG | 5-fluorouracil (5-FU) | Administered by intravenous infusion |
| DRUG | Oxaliplatin | Administered by intravenous infusion |
| DRUG | Capecitabine | Administered orally |
Timeline
- Start date
- 2025-08-27
- Primary completion
- 2027-10-30
- Completion
- 2028-04-22
- First posted
- 2025-06-29
- Last updated
- 2026-04-16
Locations
82 sites across 13 countries: United States, Austria, Brazil, China, Czechia, France, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07043400. Inclusion in this directory is not an endorsement.