Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125041
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-09-18
Brief Title:
Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
A Single-arm Multi-center and Exploratory Study of Adebelizumab Combined With Chemotherapy and Sequential Adebelizumab Combined With Radiotherapy in the Treatment of Newly Diagnosed Extensive Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
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:
To observe the efficacy and safety of adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy in the treatment of newly diagnosed extensive small cell lung cancer
Detailed Description:
This study is a one-arm multi-center and exploratory study Eligible patients will receive the following treatment schemes adebelizumabcarboplatinetoposide with one treatment cycle every three weeks After 4-6 cycles adebelizumab maintenance therapy combined with concurrent radiotherapy will be given and conventional radiotherapy will be given to chest lesions 2Gy20-30f brain 3Gy10f bone 3Gy10f adrenal gland Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum and immunotherapy is given 1-2 weeks after radiotherapy Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy
Research population patients with extensive small cell lung cancer diagnosed by histopathology or cytology both male and female aged 18-75 years old who have not received systemic treatment for small cell lung cancer before 51 patients are planned to be enrolled
Main research end point PFSRECIST v11 standard evaluated by researchers Secondary end point
Key secondary study endpoints
The incidence of adverse reactions above grade 3 in patients evaluated according to CTCAE50 version 50
Other secondary study endpoints
OS ORRRECIST v11 standard evaluated by researchers DoR evaluated by the researcher DCR assessed by the researcher PFS rate at 6 months and 1 year OS rate at 1 year and 2 years The end point of exploratory research Explore the biomarker related to curative effect
Research population patients with extensive small cell lung cancer diagnosed by histopathology or cytology both male and female aged 18-75 years old who have not received systemic treatment for small cell lung cancer before 51 patients are planned to be enrolled
Main research end point PFSRECIST v11 standard evaluated by researchers Secondary end point
Key secondary study endpoints
The incidence of adverse reactions above grade 3 in patients evaluated according to CTCAE50 version 50
Other secondary study endpoints
OS ORRRECIST v11 standard evaluated by researchers DoR evaluated by the researcher DCR assessed by the researcher PFS rate at 6 months and 1 year OS rate at 1 year and 2 years The end point of exploratory research Explore the biomarker related to curative effect
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