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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
Sponsor: BeOne Medicines
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.
Official title: An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-04-30
Completion Date
2031-12-31
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Tislelizumab
Administered by intravenous infusion
Capecitabine
Administered orally
5-fluorouracil (5-FU)
Administered by intravenous infusion
Oxaliplatin
Administered by intravenous infusion
Leucovorin
Administered by intravenous infusion
Locations (6)
Los Angeles Cancer Network
Los Angeles, California, United States
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, United States
Florida Clinical Trials Group Plantation
Plantation, Florida, United States
Florida Clinical Trials Group Tamarac
Tamarac, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Gabrail Cancer Center Research
Canton, Ohio, United States