Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429696
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Single-arm Prospective Clinical Study of PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 is a prospective single-arm clinical study designed to evaluate the 6-month progression-free survival rate 6-month PFS rate of a PD-L1 inhibitor combined with apatinib as first-line maintenance treatment for extensive-stage small cell lung cancer ES-SCLC The study plans to recruit 40 patients After receiving 4-6 cycles of induction therapy patients whose efficacy is evaluated as CR PR or SD according to RECIST 11 will enter maintenance therapy with PD-L1 inhibitor apatinib 250 mg po qd the selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase Efficacy was assessed using RECISIT 11 with imaging evaluations every 6 weeks 7 days for 48 weeks after the first dose and every 9 weeks 7 days after week 48 regardless of treatment delays or interruptions until Disease progression or study termination whichever occurs first The primary efficacy endpoint of this study is 6-month PFS rate and secondary efficacy endpoints include median PFS median OS and safety
Detailed Description:
None
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