Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265350
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-02
Brief Title:
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases A Single-center Prospective Randomized Controlled Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases
Detailed Description:
For advanced hepatocellular carcinoma HCC the lung is the most common metastatic organ accounting for 30-50 of extrahepatic diseases The standard therapy for advanced HCC with lung metastases according to the Barcelona Clinic Liver Cancer BCLC criteria is system therapy
However studies have proven that palliative ablation could improve the tumor controlling effect and the outcomes
Cryoablation is a treatment method that involves freezing tumors at extremely low temperatures to destroy and eliminate them This therapeutic approach can result in the death of tumor cells through necrosis and also stimulate immune targeting of tumor cells These immune responses occur as a result of tumor cell death caused by the ablation procedure In comparison to conventional cancer therapies cryoablation has minimal adverse reactions and has the potential to promote a more extensive and effective release of self-generated antigens into the bloodstream
Targeting vascular endothelial growth factor VEGF could reduce VEGF-mediated immunosuppression within the tumor The IMbrave150 study of atezolizumab and bevacizumab versus sorafenib demonstrated response rates of 298 vs 12 respectively and median overall survival of 198 months in the combination arm versus 134 months in the sorafenib P 0001 Bevacizumab could enhance anti-PD-1 and anti-programmed death ligand 1 PD-L1 efficacy by reversing VEGF-mediated immunosuppression and promoting T-cell infiltration in tumors 2
Cadonilimab is a first-in-class bispecific humanized IgG1 antibody targeting PD-1 and CTLA-4 which has the potential to boost immune surveillance in tumors Preclinical studies have shown that its tetravalent design enhances its high binding activity in the tumor microenvironment With no Fc binding Cadonilimab could eliminate a series of functions mediated by the Fc receptor which contribute to a poor safety profile in clinical settings
However studies have proven that palliative ablation could improve the tumor controlling effect and the outcomes
Cryoablation is a treatment method that involves freezing tumors at extremely low temperatures to destroy and eliminate them This therapeutic approach can result in the death of tumor cells through necrosis and also stimulate immune targeting of tumor cells These immune responses occur as a result of tumor cell death caused by the ablation procedure In comparison to conventional cancer therapies cryoablation has minimal adverse reactions and has the potential to promote a more extensive and effective release of self-generated antigens into the bloodstream
Targeting vascular endothelial growth factor VEGF could reduce VEGF-mediated immunosuppression within the tumor The IMbrave150 study of atezolizumab and bevacizumab versus sorafenib demonstrated response rates of 298 vs 12 respectively and median overall survival of 198 months in the combination arm versus 134 months in the sorafenib P 0001 Bevacizumab could enhance anti-PD-1 and anti-programmed death ligand 1 PD-L1 efficacy by reversing VEGF-mediated immunosuppression and promoting T-cell infiltration in tumors 2
Cadonilimab is a first-in-class bispecific humanized IgG1 antibody targeting PD-1 and CTLA-4 which has the potential to boost immune surveillance in tumors Preclinical studies have shown that its tetravalent design enhances its high binding activity in the tumor microenvironment With no Fc binding Cadonilimab could eliminate a series of functions mediated by the Fc receptor which contribute to a poor safety profile in clinical settings
Study Oversight
Has Oversight DMC:
None
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?:
None