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Tislelizumab Plus Chemotherapy for Gastric or Esophageal Cancers in Racial and Ethnic Minority Patients

This study is looking at how safe and effective a combination of medicines is for people with advanced stomach (gastric), gastroesophageal (where the stomach meets the esophagus), or esophageal (food pipe) cancers that cannot be removed by surgery. The main drug being studied is tislelizumab, given with chemotherapy drugs like capecitabine, 5-fluorouracil (5-FU), oxaliplatin, and leucovorin. You might be able to join if you identify as a racial or ethnic minority, are at least 18 years old, and your cancer has specific markers called HER2-negative and PD-L1-positive. The study will mainly track any side effects (adverse events) over about 12 months to see how safe the treatment is. The study plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for approximately 12 months. The overall study duration will be up to approximately 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07554521

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
BeOne Medicines
~30 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:TislelizumabCapecitabine5-fluorouracil (5-FU)OxaliplatinLeucovorin

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over Approximately 12 months

Conditions

Advanced Unresectable Gastric Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Advanced Gastroesophageal Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaEsophageal Squamous Cell CarcinomaGastric AdenocarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

8 sites across 4 states
Florida4
California2
Missouri1
Ohio1

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1-877-828-5568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable
Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1
Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment
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 and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment
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 and ≥ 180 days after the last dose of chemotherapy

Exclusion

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
Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:
Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)
Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment
Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and/or fistulae (including prior gastric fistula operation) within 6 months prior to study treatment
Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)
Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.

What this trial measures

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Approximately 12 months

    Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively