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A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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Trial Profile

A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Nofazinlimab (Primary) ; Lenvatinib
  • Indications Liver cancer
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors CStone Pharmaceuticals

Most Recent Events

  • 23 Aug 2024 According to a CStone Pharmaceuticals media release,Final OS analysis expected in 2025 H1; seeking ex-China partnership opportunities.
  • 23 Aug 2024 According to a CStone Pharmaceuticals media release, in March 2024 company completed a prespecified interim analysis for the global phase III trial of nofazinlimab in combination with LENVIMA (lenvatinib) for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma. No new or unexpected safety signals were observed, and the independent Data Monitoring Committee recommended continuing the trial without protocol modifications until the final OS analysis.
  • 01 Nov 2023 According to a CStone Pharmaceuticals media release, the study is currently in progress and is expected to be Key research results will be announced in the first quarter of 2024.

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