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

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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

Locations (85)