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A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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Trial Profile

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Tislelizumab (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Oxaliplatin; Paclitaxel
  • Indications Adenocarcinoma; Oesophageal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 306
  • Sponsors BeiGene

Most Recent Events

  • 04 Mar 2025 According to a BeiGene media release, company announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA (tislelizumab-jsgr), in combination with platinum containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
  • 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 esophageal squamous cell carcinoma (ESCC).

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