Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597513
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults It will also assess the safety of this treatment approach
The main questions it aims to answer are
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates What medical problems do participants experience whild undergoing this treatment
Participants will
Complete two 21-days cycles of standard-dose etoposide and carboplatin followed by G-CSF for stem cell mobilization
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles
If eligible participants will receive etoposide and carboplatin plus adebrelimab for four cycles
Finally participants may enter a maintenance phase with adebrelimab
Throughout the trial participants will
Visit the clinic every 21 days for check-ups and tests Imaging examination every 6 weeks Followed up by telephone every 2 months
The main questions it aims to answer are
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates What medical problems do participants experience whild undergoing this treatment
Participants will
Complete two 21-days cycles of standard-dose etoposide and carboplatin followed by G-CSF for stem cell mobilization
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles
If eligible participants will receive etoposide and carboplatin plus adebrelimab for four cycles
Finally participants may enter a maintenance phase with adebrelimab
Throughout the trial participants will
Visit the clinic every 21 days for check-ups and tests Imaging examination every 6 weeks Followed up by telephone every 2 months
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