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A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)

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Trial Profile

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 10 Jun 2025

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At a glance

  • Drugs Fruquintinib (Primary) ; Sintilimab (Primary) ; Axitinib; Everolimus
  • Indications Renal cell carcinoma
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms FRUSICA-2
  • Sponsors HUTCHMED

Most Recent Events

  • 04 Jun 2025 According to a HUTCHMED media release, data from this trial will be submitted for presentation at an upcoming scientific conference
  • 04 Jun 2025 According to a HUTCHMED media release, company announce that the New Drug Application (NDA) for the combination of fruquintinib and sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor has been accepted for review by the China National Medical Products Administration (NMPA).
  • 19 Mar 2025 According to a HUTCHMED media release, Results from the FRESCO-2 trial were published in The Lancet in June 2023

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