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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

NCT07554521 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2031-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554521 on ClinicalTrials.gov