Subcutaneous versus intravenous tislelizumab with chemotherapy for unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares subcutaneous (SC) versus intravenous (IV) administration of the PD‑1 antibody tislelizumab, each given with standard chemotherapy (cisplatin, leucovorin, and 5‑fluorouracil), as first‑line therapy for adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Approximately 351 patients will undergo screening, receive assigned treatment during a defined treatment period, and be followed for safety and outcomes. The primary focus is on systemic drug exposure and pharmacokinetics after SC versus IV dosing, with tumor tissue collection for biomarker analyses and response assessment by RECIST v1.1. Eligibility requires ECOG 0–1, adequate organ function, and availability of tumor tissue.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Ironwood Cancer and Research Centers Chandler Ii
  Chandler, Arizona, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• UC Health Cancer Care and Hematology Clinic Memorial Hospital Central
  Colorado Springs, Colorado, United States Recruiting
• Bioresearch Partners Holding Hialeah Hospital
  Hialeah, Florida, United States Recruiting
• Orlando Health Cancer Institute Downtown Orlando
  Orlando, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

+45 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BeOne Medicines
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.