Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05773105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: