Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

Study Overview
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Brief Summary
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A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Detailed Description
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This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.

Official Title
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A Randomized, Prospective Study of the Efficacy and Safety of the 1st Treatment in Advanced Central NSCLC by PD-1/PD-L1 Inhibitor and Chemotherapy With/Without Bronchoscopic Microwave Intervention

Conditions
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Effect Increased, Safety Issues

Intervention / Treatment
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* Procedure: bronchoscopic microwave intervention
* Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy Exclusion Criteria: contraindications to tracheoscopy, chemotherapy, and immunotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy<br>anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy | Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy<br>* anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy<br>* Other names: Systemic treatment;|
| Experimental: combined with bronchoscopic microwave intervention<br>anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention | Procedure: bronchoscopic microwave intervention<br>* bronchoscopic microwave intervention<br>* Other names: Local treatment;Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy<br>* anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy<br>* Other names: Systemic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | objective response rate | 6 weeks | 
| progression-free survival | progression-free survival | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate | disease control rate | 6 weeks | 
| overall survival | overall survival | 2 years | 
| adverse events | adverse events | 3 weeks | 
| quality of life score | quality of life score | World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, anti-PD-1 / PD-L1 monoclonal antibody, bronchoscopic microwave intervention, advanced central non-small cell lung cancer patients