NCT07043400 · BeiGene
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
What this study is about
This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a injected under the skin (SC) injection compared to given through a vein (IV) infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment
View original scientific description
This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study.
Interventions
DRUG
Subcutaneous Tislelizumab
Administered by subcutaneous injection
DRUG
Intravenous Tislelizumab
Administered by intravenous infusion
DRUG
Cisplatin
Administered by intravenous infusion
DRUG
Leucovorin
Administered by intravenous infusion
DRUG
5-fluorouracil (5-FU)
Administered by intravenous infusion
DRUG
Oxaliplatin
Administered by intravenous infusion
DRUG
Capecitabine
Administered orally
Primary outcome measures
Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab
Time frame: 85 Days
Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab
Time frame: 21 Days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 leptomenin
Where
- Chandler, Arizona
- Los Alamitos, California
- Colorado Springs, Colorado
- Hialeah, Florida
- Orlando, Florida
- Chicago, Illinois
- Hinsdale, Illinois
- Kansas City, Kansas
- Westbrook, Maine
- Bridgeton, Missouri
- Lincoln, Nebraska
- Las Vegas, Nevada
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations