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NCT07043400 · ClinicalTrials.gov registry record · Phase 3
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 study of Gastroesophageal Junction Adenocarcinoma and Metastatic Gastric Adenocarcinoma, sponsored by BeOne Medicines.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT07043400: Recruiting Phase 3 study of Gastroesophageal Junction Adenocarcinoma and Metastatic Gastric Adenocarcinoma, sponsored by BeOne Medicines.
NCT07043400 is a Phase 3 study of Gastroesophageal Junction Adenocarcinoma and Metastatic Gastric Adenocarcinoma that is actively recruiting participants, run by BeOne Medicines. The registered enrollment target is 351 participants, below the 395-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07043400, a Phase 3 study of Gastroesophageal Junction Adenocarcinoma and Metastatic Gastric Adenocarcinoma, is actively recruiting participants, sponsored by BeOne Medicines.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 351 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Leucovorin
- DRUG Subcutaneous Tislelizumab
- DRUG Intravenous Tislelizumab
- DRUG 5-fluorouracil (5-FU)
Study Locations (20)
Other
- Krankenhaus Der Barmherzigen Schwestern Linz - Linz
- Hospital de Amor Barretos - Barretos
- CECAP - Blumenau
Florida
- Bioresearch Partners Holding Hialeah Hospital - Hialeah
- Orlando Health Ufhealth Cancer Center - Orlando
Illinois
- Northwestern University - Chicago
- Hope and Healing Cancer Services - Hinsdale
New Jersey
- Hunterdon Hematology Oncology - Flemington
- Summit Medical Group - Florham Park
Texas
- Md Anderson Cancer Center - Houston
- Scott and White Memorial Hospital - Temple
Arizona
- Ironwood Cancer and Research Centers - Chandler
California
- Cancer and Blood Specialty Clinic - Los Alamitos
Kansas
- University of Kansas Medical Center Research Institute - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2028-04-22 |
| Phase | Phase 3 |
What NCT07043400 shows while recruiting
NCT07043400 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 395-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (11% lower).
The record links to 2 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT07043400 names 20 study sites across 14 states, led by Other, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT07043400 about?
NCT07043400 is a clinical study titled "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". 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 b...
What is the current status of trial NCT07043400?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2025-08-27. Estimated completion is 2028-04-22.
What conditions does trial NCT07043400 study?
This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma.
What interventions are being tested in trial NCT07043400?
The interventions under investigation include: Cisplatin (DRUG), Leucovorin (DRUG), Subcutaneous Tislelizumab (DRUG), Intravenous Tislelizumab (DRUG), 5-fluorouracil (5-FU) (DRUG).
Who is sponsoring clinical trial NCT07043400?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07043400 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Junction Adenocarcinoma
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Where NCT07043400's enrollment target sits among peer trials
351 13th of 40 higher than 28 of 40 other Gastroesophageal Junction Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Junction Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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