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
Public ClinicalTrials.gov record NCT07043400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07043400
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 351 participants
Conditions and interventions
Interventions
- Subcutaneous Tislelizumab Drug
- Intravenous Tislelizumab Drug
- Cisplatin Drug
- Leucovorin Drug
- 5-fluorouracil (5-FU) Drug
- Oxaliplatin Drug
- Capecitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2025 (Actual)
- Primary completion
- Oct 30, 2027 (Estimated)
- Completion
- Apr 22, 2028 (Estimated)
- Last update posted
- Oct 14, 2026
2025 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers Chandler Ii | Chandler | Arizona | 85224-5665 | Recruiting |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | Recruiting |
| UC Health Cancer Care and Hematology Clinic Memorial Hospital Central | Colorado Springs | Colorado | 80909 | Recruiting |
| Bioresearch Partners Holding Hialeah Hospital | Hialeah | Florida | 33013-3804 | Recruiting |
| Orlando Health Cancer Institute Downtown Orlando | Orlando | Florida | 32806 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | 60521-0509 | Recruiting |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160-8500 | Recruiting |
| New England Cancer Specialists | Westbrook | Maine | 04092 | Recruiting |
| St Louis Cancer Care, Llp | Bridgeton | Missouri | 63044 | Recruiting |
| Nebraska Hematology Oncology | Lincoln | Nebraska | 68506-7548 | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169-3321 | Recruiting |
| Hunterdon Hematology Oncology | Flemington | New Jersey | 08822-4603 | Recruiting |
| Summit Medical Group | Florham Park | New Jersey | 07932-1049 | Recruiting |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | Recruiting |
| Vanderbilt University | Nashville | Tennessee | 37232 | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | 77030-4009 | Recruiting |
| Baylor Scott and White Medical Center Temple | Temple | Texas | 76508-0001 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07043400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07043400 live on ClinicalTrials.gov.