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
Overview
- Phase
- N/A
- Intervention
- anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
- Conditions
- Effect Increased
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 50
- Primary Endpoint
- objective response rate
- Last Updated
- 6 years ago
Overview
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.
Investigators
Caicun Zhou
Director, Head of Oncology, Principal Investigator, Clinical Professor
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria
- •advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy
Exclusion Criteria
- •contraindications to tracheoscopy, chemotherapy, and immunotherapy
Arms & Interventions
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Intervention: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
combined with bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
Intervention: bronchoscopic microwave intervention
combined with bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
Intervention: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Outcomes
Primary Outcomes
objective response rate
Time Frame: 6 weeks
objective response rate
progression-free survival
Time Frame: 1 years
progression-free survival
Secondary Outcomes
- overall survival(2 years)
- disease control rate(6 weeks)
- adverse events(3 weeks)
- quality of life score(World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.)