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A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

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Trial Profile

A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2024

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At a glance

  • Drugs Sugemalimab (Primary) ; Cisplatin; Fluorouracil
  • Indications Carcinoma; Oesophageal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMSTONE-304
  • Sponsors CStone Pharmaceuticals

    • Most Recent Events

    • 26 Jul 2024 According to a CStone Pharmaceuticals media release, company is preparing to submit Marketing Authorization Application for first-line Esophageal Cancer indication.
    • 01 Mar 2024 Results for safety and efficacy, published in the Nature Medicine
    • 08 Dec 2023 According to Cstone Pharmaceuticals media release, based on the data from the GEMSTONE-304 study the National Medical Products Administration (NMPA) of China has approved the supplemental biologics license application (sBLA) for sugemalimab (Cejemly) in combination with fluorouracil and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

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