NCT03777657

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 997 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric, or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg intravenously (IV) on Day 1 of each 21-day cycle
DRUG	Placebo	Placebo to match tislelizumab IV on Day 1 of each 21-day cycle
DRUG	Cisplatin	80 mg/m² IV on Day 1 of each 21-day cycle
DRUG	Oxaliplatin	130 mg/m² IV on Day 1 of each 21-day cycle
DRUG	Capecitabine	1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle
DRUG	5-Fluorouracil	800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Timeline

• Start date: 2018-12-13
• Primary completion: 2023-02-28
• Completion: 2024-08-27
• First posted: 2018-12-17
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

149 sites across 13 countries: United States, China, France, Italy, Japan, Poland, Puerto Rico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study