Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

Not Applicable

• Conditions: Safety Issues; Effect Increased
• Interventions: Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy; Procedure: bronchoscopic microwave intervention

• Registration Number: NCT04360655
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Study Start: 2020-05-01
• Primary Completion: 2022-04-30
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy

Exclusion Criteria

• contraindications to tracheoscopy, chemotherapy, and immunotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
combined with bronchoscopic microwave intervention	bronchoscopic microwave intervention	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
combined with bronchoscopic microwave intervention	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Primary Outcome Measures

Name	Time	Method
objective response rate	6 weeks	objective response rate
progression-free survival	1 years	progression-free survival

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years	overall survival
disease control rate	6 weeks	disease control rate
adverse events	3 weeks	adverse events
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