Spots Global Cancer Trial Database for A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC

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Trial Identification

Brief Title: A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC

Official Title: Cadonilimab Combined With Regorafenib for Patients With Hepatocellular Carcinoma Who Progressed on Systemic Therapy: An Open Label, Single Arm, Single Center, Prospective, Phase I/II Trial

Study ID: NCT05773105

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Cadonilimab+regorafenib

Study Description

Brief Summary: To evaluate the efficacy and safety of cadonilimab combined with regorafenib in patients with HCC who progressed on systemic therapy.

Detailed Description: Currently, second-line treatment options for advanced HCC (aHCC) patients including single TKI or anti-PD-(L)1 remains limited survival benefits and objective responses. To explore more effective and safer second-line or later therapies for aHCC is necessary. Cadonilimab is a first-in-class humanized IgG1 bispecific antibody that binds to PD-1 and CTLA-4 simultaneously. Dual checkpoint inhibition of the PD-1 and CTAL4 pathways with single cadonilimab has the potential to boost immune surveillance in HCC. Previously data indicated that cadonilimab possesses an encouraging anti-tumour activity and an improved safety profile compared to the co-administration of anti-PD-1 plus anti-CTLA-4 antibodies. Regorafenib is a TKI and approved for second-line treatment of uHCC globally. Here, the investigators evaluated the safety of cadonilimab plus regorafenib as second-line or later therapy in patients with aHCC.