Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574412
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Cardonilizumab Combined With Lenvastinib in Perioperative Treatment of Resectable Renal Clear Cell Carcinoma-A Single-arm Single-center Exploratory Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-arm single-center phase II clinical study The main purpose is to evaluate the perioperative efficacy and safety of cardenilimab combined with lenvatinib in patients with resectable clear cell renal cell carcinoma This study included a screening period a treatment period and a follow-up period After completing the examination and assessment during the screening period qualified subjects will enter the study treatment period after signing the informed consent form Subjects should receive induction therapy and maintenance therapy in accordance with the protocol until there is disease progression on imaging as judged by the investigator based on RECIST 11 standards intolerable toxicity or the subject voluntarily requests to terminate study treatment or withdraws information Agree or the researcher determines that treatment needs to be terminated 1 Primary research endpoint Objective response rate ORR of primary tumor according to RECIST 11 criteria 2 Secondary research endpoint 1 According to RECIST 11 as assessed by the investigator 1 Progression-free survival Progress Free Survival PFS 2 Overall survival OS 2 Type incidence and severity of adverse events AE and serious adverse events SAE assessed in accordance with NCI-CTCAE 50 3 Pathological response rate MPR R0 resection rate 4 Based on Quality of Life QoL score
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None