Actively Recruiting
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
Led by BeOne Medicines · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identifies as a member of racial and/or ethnic minority populations as defined by the 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 or esophageal squamous cell carcinoma
- No previous systemic therapy for locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma or esophageal squamous cell carcinoma
- At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment
- Positive tumor programmed death-ligand 1 (PD-L1) expression with documented results
- Eastern Cooperative Oncology Group Performance Status score 64 1
- Adequate organ function based on laboratory values within 14 days prior to study treatment
- Women of childbearing potential must use highly effective birth control during the study and for at least 120 days after the last dose of tislelizumab and 180 days after the last dose of chemotherapy, and have a negative pregnancy test within 7 days prior to treatment
- Non-sterile males must use highly effective birth control during the study and for at least 120 days after the last dose of tislelizumab and 180 days after the last dose of chemotherapy
You will not qualify if you...
- Squamous cell, undifferentiated, or other histological types of gastric cancer
- Active leptomeningeal disease or uncontrolled brain metastasis; asymptomatic and stable brain metastases without corticosteroids for at least 4 weeks are allowed
- Evidence of esophageal/bronchial or esophageal/aorta fistula or complete esophageal obstruction not treatable
- Gastric or gastroesophageal adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2) status
- Active autoimmune diseases or history of autoimmune diseases that may relapse, except controlled Type I diabetes, hypothyroidism managed with hormone therapy, controlled celiac disease, skin diseases not requiring systemic treatment, or other diseases unlikely to recur without triggers
- Any active malignancy within 2 years prior to study treatment, except the cancer under study or locally recurring cancers treated curatively
- Uncontrollable pleural effusion, pericardial effusion, or ascites needing frequent drainage or diuretics within 7 days prior to treatment
- Clinically significant gastrointestinal bleeding within 1 month prior to treatment
- History of gastrointestinal perforation or fistula within 6 months prior to treatment
- Clinically significant bowel obstruction
- Use of systemic corticosteroids (>10 mg prednisone daily or equivalent) or other immunosuppressive medications within 14 days prior to treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, United States, 33013-3804
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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