At a glance
ClinicalIndex Comparison Record- ✓Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, histologically confirmed
- ✓No prior systemic therapy for advanced/metastatic disease (prior neoadjuvant/adjuvant allowed if completed with ≥6 months recurrence-free interval)
- ✓ECOG performance status 0-1
- ✓Adequate organ function assessed ≤7 days prior to randomization
- ✕Squamous cell, undifferentiated, or other non-adenocarcinoma histological types
- ✕Active leptomeningeal disease or uncontrolled brain metastasis
- ✕HER2-positive gastric or GEJ adenocarcinoma
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell co-stimulation/checkpoint pathway inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
In Brief
A Phase 3 clinical trial evaluating Tislelizumab, Placebo, and 4 other interventions for Gastric, or Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 997 participants across 149 sites in 13 countries.
Detailed Summary
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study Details
Timeline
Interventions
200 mg intravenously (IV) on Day 1 of each 21-day cycle
Placebo to match tislelizumab IV on Day 1 of each 21-day cycle
80 mg/m² IV on Day 1 of each 21-day cycle
130 mg/m² IV on Day 1 of each 21-day cycle
1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle
800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle