RecruitingPhase 2NCT07554521

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

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


Sponsor

BeOne Medicines

Enrollment

30 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-fluorouracil (5-FU), a drug called Capecitabine, and others for people with advanced gastroesophageal adenocarcinoma, advanced unresectable gastric adenocarcinoma, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Administered by intravenous infusion

DRUGCapecitabine

Administered orally

DRUG5-fluorouracil (5-FU)

Administered by intravenous infusion

DRUGOxaliplatin

Administered by intravenous infusion

DRUGLeucovorin

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

View Full Details on ClinicalTrials.gov

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NCT07554521


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