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A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

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Trial Profile

A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2026

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At a glance

  • Drugs Serplulimab (Primary) ; Cisplatin; Fluorouracil
  • Indications Oesophageal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTRUM-007
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 20 Jul 2026 According to a Henlius Biopharmaceuticals media release, the results form this trial will be presented at the 2026 European Society for Medical Oncology (ESMO) Congress will take place from October 23-7 in Madrid, Spain.
  • 10 May 2026 According to a Henlius Biopharmaceuticals media release, based on data from ASTRUM-007 study, the company has received European Commission (EC) approval for serplulimab in patients with unresectable locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC), whose tumours express PD-L1 with a CPS greater or equal to 5.
  • 30 Mar 2026 According to a Henlius Biopharmaceuticals media release, based on results from the ASTRUM-002 and ASTRUM-007 studies, serplulimab has received two positive opinions from the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP).

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