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A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

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Trial Profile

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2025

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At a glance

  • Drugs Cadonilimab (Primary) ; Lenvatinib
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPASSION-36
  • Sponsors Akeso Biopharma

Most Recent Events

  • 14 Sep 2025 According to Akeso media release, first patient has been dosed in the global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial is currently ongoing in China, the U.S. and Europe.
  • 04 Aug 2025 Status changed from not yet recruiting to recruiting.
  • 04 Aug 2025 According to Akeso media release, The company have received an approval from China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) to initiate this trial.

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