Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604351
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction A Phase II Study
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:
Example
Brief Summary:
This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction
Detailed Description:
This is a prospective interventional clinical study to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic Non-small Cell Lung Cancer with central airway obstruction
Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction without EGFR-sensitive mutations 19del L858R and T790M were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab Nab-Paclitaxel and Carboplatin until disease progression intolerable toxicity or meeting the criteria for discontinuation of the trial drug
The primary endpoint is the investigator-assessed objective response rate ORR of airway tumors Secondary endpoints include the pathological response rate PRR of airway tumors disease control rate DCR improvement rate of FEV1 duration of response DOR for airway tumors progression-free survival PFS overall survival OS quality of life assessment and safety Recruitment for the study is expected to begin in mainland China around October 2024 with the trial anticipated to conclude in October 2027
Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction without EGFR-sensitive mutations 19del L858R and T790M were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab Nab-Paclitaxel and Carboplatin until disease progression intolerable toxicity or meeting the criteria for discontinuation of the trial drug
The primary endpoint is the investigator-assessed objective response rate ORR of airway tumors Secondary endpoints include the pathological response rate PRR of airway tumors disease control rate DCR improvement rate of FEV1 duration of response DOR for airway tumors progression-free survival PFS overall survival OS quality of life assessment and safety Recruitment for the study is expected to begin in mainland China around October 2024 with the trial anticipated to conclude in October 2027
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