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A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy

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Trial Profile

A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Camrelizumab (Primary) ; Rivoceranib (Primary) ; Sorafenib
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CARES 310
  • Sponsors Jiangsu Hengrui Medicine Co.

Most Recent Events

  • 21 Oct 2024 According to a Elevar Therapeutics media release, Company announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2025.
  • 23 Sep 2024 According to a Elevar Therapeutics media release, Company resubmits New Drug Application to the U.S. Food and Drug Administration (FDA) for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis.
  • 12 Sep 2024 Results presented in the Elevar Therapeutics Media Release.

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