drugset / Trial / NCT07554521
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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-30
- Primary completion
- 2031-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-Fluorouracil (5-FU) | Small molecule | 800 mg | Intravenous |
| Subject | 5-Fluorouracil (5-FU) | Small molecule | 2400 mg | Intravenous |
| Subject | 5-Fluorouracil (5-FU) | Small molecule | 2800 mg | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 150 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |