Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06604351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
Sponsor:
Hunan Province Tumor Hospital
Organization:
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:
False
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?:
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?: