Health Trials

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

ConditionsAdvanced Unresectable Gastric AdenocarcinomaEsophageal Squamous Cell CarcinomaAdvanced Gastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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 criteria

Qualifiers

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 African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander

Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC)

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

Disqualifiers

Patient has squamous cell or undifferentiated or other histological type gastric cancer

Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before study treatment.

Patients with evidence of esophageal/bronchial or esophageal/aorta fistula, or complete esophageal obstruction not amenable to treatment.

Diagnosed with GAC/GEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment

Trial design

Treatments tested in this trial

  • Tislelizumab
  • Capecitabine
  • 5-fluorouracil (5-FU)
  • Oxaliplatin
  • Leucovorin

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov