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

Part of paid clinical trials in Hialeah, Florida.

Sponsor
BeOne Medicines
Study ID
NCT07554521
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Gastroesophageal Adenocarcinoma
  • Advanced Unresectable Gastric Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    Administered by intravenous infusion
  • Capecitabine — DRUG
    Administered orally
  • 5-fluorouracil (5-FU) — DRUG
    Administered by intravenous infusion
  • Oxaliplatin — DRUG
    Administered by intravenous infusion
  • Leucovorin — DRUG
    Administered by intravenous infusion

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA)
    Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens: * FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W). * CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W). * Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W.
  • Experimental: Esophageal Squamous Cell Carcinoma (ESCC)
    Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bioresearch Partners Holding Hialeah HospitalHialeahFlorida33013-3804-

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By research site
Bioresearch Partners Holding Hialeah Hospital· Hialeah, FL

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