Compares tislelizumab by injection or infusion with chemotherapy in advanced stomach cancer
Compares tislelizumab as an injection or an infusion in adults with advanced stomach cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Mérida, Mexico City, and Oaxaca City, MexicoSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you had medicine for the cancer (such as chemotherapy) since it was found that it cannot be removed by surgery or has spread?
- Has your doctor told you that the cancer cannot be removed by surgery, or that it has spread to other parts of the body?
- Has a test of your tumour shown that it is HER2-positive?
Source: NCT07043400, who can take part
Where in Mexico
- Medical Care and Research Sa de CvMérida, MexicoTaking people
- Health Pharma Professional Research SA de CVMexico City, MexicoTaking people
- Centro de Investigacion Clinica de OaxacaOaxaca City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT07043400EU 2025-522862-58-00
- Record updated
- 14 October 2026
- Original 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. The study is composed of a screening period, a treatment period, and a follow-up period.Read full original descriptionShow less
A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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. The study is composed of a screening period, a treatment period, and a follow-up period.
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: 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; 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; Squamous cell or undifferentiated or other histological type gastric cancer (GC); Active autoimmune diseases or history of autoimmune diseases that may relapse; Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).