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RECRUITING
NCT07554521
PHASE2

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

View on ClinicalTrials.gov

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

2026-05-11

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

Administered by intravenous infusion

DRUG

Capecitabine

Administered orally

DRUG

5-fluorouracil (5-FU)

Administered by intravenous infusion

DRUG

Oxaliplatin

Administered by intravenous infusion

DRUG

Leucovorin

Administered by intravenous infusion

Locations (1)

Bioresearch Partners Holding Hialeah Hospital

Hialeah, Florida, United States