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NCT07554521 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
A Phase 2 study, sponsored by BeOne Medicines.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT07554521: Recruiting Phase 2 study, sponsored by BeOne Medicines.
NCT07554521 is a Phase 2 study that is actively recruiting participants, run by BeOne Medicines. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07554521, a Phase 2 study, is actively recruiting participants, sponsored by BeOne Medicines.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.
Primary Outcome
Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively
Interventions
- DRUG Capecitabine
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Tislelizumab
- DRUG 5-fluorouracil (5-FU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What NCT07554521 shows while recruiting
NCT07554521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT07554521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07554521 about?
NCT07554521 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States". The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unr...
What is the current status of trial NCT07554521?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-04-30. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07554521?
The interventions under investigation include: Capecitabine (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Tislelizumab (DRUG), 5-fluorouracil (5-FU) (DRUG).
Who is sponsoring clinical trial NCT07554521?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07554521's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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