Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363006
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-28
Brief Title:
Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Cardonilimab Injection Combined With TKI as Second-line Treatment for Advanced Hepatocellular Carcinoma A Single-arm Open-label Multicenter Real-world Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma The main questions it aims to answer are
Objective response rate ORR for evaluation
Disease Control Rate DCR Duration of relief DoR Progression free survival PFS Total survival time OS Safety
Objective response rate ORR for evaluation
Disease Control Rate DCR Duration of relief DoR Progression free survival PFS Total survival time OS Safety
Detailed Description:
Have received at least one prior systemic treatment progression or intolerance for HCC Cardonilizumab was administered every 2 weeks on the first day of each cycle for up to 24 months in the absence of investigator judgment that there is no longer a clinical continuation benefit intolerable toxicity initiation of a new antitumor therapy withdrawal of informed consent loss of follow-up death or other protocol requirements for treatment termination Cardonilizumab will complete infusion within 60 minutes 10 minutes Continuous monitoring of potential infusion reactions and allowing pre-treatment of hypersensitivity reactions or infusion rate adjustment according to protocol guidelines For subjects who cannot tolerate a 60-minute infusion the infusion time can be extended up to 120 minutes Dose adjustment of cardonilizumab is not allowed during treatment but delayed dosing is allowed for up to 12 weeks since the last dosing time If glucocorticoids are used in the treatment of irAE In both cases where the glucocorticoid reduction process resulted in the suspension of cardonilizumab for more than 12 weeks or in the treatment of AE that may or may not be related to cardonilizumab and where the investigator determined that the patient would benefit from continued treatment permission to continue treatment was required after discussion with the sponsor medical Ombudsman
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?:
False
Is an FDA AA801 Violation?:
None