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Tislelizumab for Unresectable or Metastatic Gastric or GEJ Adenocarcinoma

This study is testing two ways of giving a drug called tislelizumab: as a shot under the skin (subcutaneous) or through a vein (intravenous infusion), along with chemotherapy (cisplatin, leucovorin, and 5-fluorouracil). It's for adults with stomach (gastric) or gastroesophageal junction (GEJ) cancer that has spread or cannot be removed by surgery, and who haven't had prior treatment for advanced disease. The main goal is to see how much tislelizumab is in your body and for how long, comparing the shot to the infusion. We're looking at drug levels at 21 and 85 days. The study is currently unclear on its recruitment status and plans to enroll about 351 patients.

Study design
This interventional study plans to enroll about 351 participants. It compares subcutaneous tislelizumab to intravenous tislelizumab, both given with chemotherapy.
What's involved
The study involves a screening period, a treatment period, and a follow-up period. Specific details about visits or procedures are not provided.
Compensation
Not stated in the trial record.
Follow-up
The study includes a follow-up period after treatment. Drug levels are measured at 21 and 85 days.

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

NCT07043400

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~351 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Subcutaneous TislelizumabIntravenous TislelizumabCisplatinLeucovorin5-fluorouracil (5-FU)Oxaliplatin

At a glance

Recruiting sites
89 of 95 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab
Measured over 85 Days
+1 more outcome measured

Conditions

Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Explore related trials

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT07043400

Where you'd take part

This study runs at 95 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Acibadem Adana Hospital

    Kuruköprü, Turkey (Türkiye)no site contact published

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, Chinano site contact published

    Recruiting

  • Anyang Tumor Hospital

    Anyang, Henan, Chinano site contact published

    Recruiting

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, Italyno site contact published

    Recruiting

  • Bioresearch Partners Holding Hialeah Hospital

    Hialeah, Floridano site contact published

    Recruiting

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, United Kingdomno site contact published

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, Californiano site contact published

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

BeOne Medicines
[email protected]
1-877-828-5568
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab85 Days
  • Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab21 Days