NCT05773105

A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab+regorafenib	cadonilimab(10mg/kg, iv,Q3W,D1) + regorafenib(80mg,PO,QD,everyday)

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2023-03-17
• Last updated: 2024-01-16

Locations

1 site across 1 country: China