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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 20 Feb 2025

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At a glance

  • Drugs Tislelizumab (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 305
  • Sponsors BeiGene

    • Most Recent Events

    • 27 Dec 2024 According to a BeiGene media release, company announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma based on the results of RATIONALE-305 trial.
    • 27 Nov 2024 According to a BeiGene media release, company announced that the European Commission has approved TEVIMBRA (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma based on the data from the RATIONALE-305 and 306 trials.
    • 21 Oct 2024 According to a BeiGene media release, based on results form this trial the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for TEVIMBRA (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

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