Effect Increased, Safety Issues
Conditions
Keywords
anti-PD-1 / PD-L1 monoclonal antibody, chemotherapy, bronchoscopic microwave intervention, advanced central non-small cell lung cancer patients
Brief summary
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
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.
Interventions
bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Sponsors
Study design
Eligibility
Inclusion criteria
* advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy
Exclusion criteria
* contraindications to tracheoscopy, chemotherapy, and immunotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 6 weeks | objective response rate |
| progression-free survival | 1 years | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 3 weeks | adverse events |
| disease control rate | 6 weeks | disease control rate |
| overall survival | 2 years | overall survival |
| quality of life score | World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100,higher scores mean a better outcome. | quality of life score |