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A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Compare Toripalimab Injection (JS001) Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in Treatment of Advanced or Metastatic Esophageal Squamous Cell Cancer (ESCC) Without Previous Systemic Chemotherapy

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Trial Profile

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Compare Toripalimab Injection (JS001) Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in Treatment of Advanced or Metastatic Esophageal Squamous Cell Cancer (ESCC) Without Previous Systemic Chemotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2024

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At a glance

  • Drugs Cisplatin (Primary) ; Paclitaxel (Primary) ; Toripalimab (Primary)
  • Indications Oesophageal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms JUPITER06
  • Sponsors Shanghai Junshi Biosciences

Most Recent Events

  • 16 Nov 2024 According to a Junshi Biosciences Media Release, company announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI) for ESCC indication.
  • 24 Sep 2024 According to a Junshi Biosciences Media Release, company announced that the European Commission (EC) has approved Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC) based on the results from the JUPITER-06 study.
  • 26 Jul 2024 According to a Junshi Biosciences Media Release, based on the results from this study, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for the marketing authorization application (MAA) for toripalimab.

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