Last updated 12 days ago
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
351 patients around the world
Available in Puerto Rico, Brazil, Argentina, United States, Mexico
BeiGene
18Research sites
351Patients around the world
This study is for people with
Gastroesophageal cancer
Gastric adenocarcinoma
Gastroesophageal adenocarcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.Must be able to provide tumor tissues for biomarker assessment.Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.Adequate organ function.Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.
- Squamous cell or undifferentiated or other histological type gastric cancer (GC).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 randomization.Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).Active autoimmune diseases or history of autoimmune diseases that may relapse.Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Hospital Alemán
Hospital de Gastroenterología Dr.Carlos Bonorino Udaondo
Hospital Brasília
Hospital Universitário Onofre Lopes - HUOL
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
SponsorBeiGene
Study typeInterventional
Conditions
Gastric adenocarcinomaGastroesophageal adenocarcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07043400
