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, 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.

Trial Details

NCT ID
NCT07554521
Phase
PHASE2
Sponsor
BeOne Medicines
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Tislelizumab
  • Capecitabine
  • 5-fluorouracil (5-FU)
  • Oxaliplatin
  • Leucovorin
Locations (sample)
  • Hialeah, Florida, United States|25.8576,-80.27811

Key Eligibility Criteria

  • Self-identifies as a member of racial and/or ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or Afr…
  • Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous c…
  • No previous systemic therapy for locally advanced unresectable or metastatic GAC/GEA or ESCC
  • At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment

For full eligibility, visit ClinicalTrials.gov.

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