Phase 3 Study Comparing Subcutaneous Injection Versus Intravenous Infusion of Tislelizumab Plus Chemotherapy for First-Line Treatment of Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating the levels of drug exposure in adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This Phase 3 study compares tislelizumab given by subcutaneous injection versus intravenous infusion as first-line therapy combined with chemotherapy. The study involves approximately 351 participants and aims to understand the treatments effects in this patient group. Participants will be randomly assigned to receive either tislelizumab 300 mg by subcutaneous injection or 200 mg by intravenous infusion on Day 1 of each 21-day cycle. Both groups will also receive chemotherapy tailored to each patient. The study includes a screening period, a treatment period with repeated cycles, and a follow-up period to assess long-term outcomes. During the study, participants will be monitored through various assessments, including tumor evaluations and biomarker tests. Researchers will measure drug concentration levels, response rates, progression-free survival, overall survival, and adverse events for up to two years. Safety and treatment effectiveness will be closely followed throughout the study duration, which ends in April 2028.

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