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Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04360655
Enrollment
50
Registered
2020-04-24
Start date
2020-05-01
Completion date
2023-05-01
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect Increased, Safety Issues

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

PROCEDUREbronchoscopic microwave intervention

bronchoscopic microwave intervention

DRUGanti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* contraindications to tracheoscopy, chemotherapy, and immunotherapy

Design outcomes

Primary

MeasureTime frameDescription
objective response rate6 weeksobjective response rate
progression-free survival1 yearsprogression-free survival

Secondary

MeasureTime frameDescription
adverse events3 weeksadverse events
disease control rate6 weeksdisease control rate
overall survival2 yearsoverall survival
quality of life scoreWorld Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100,higher scores mean a better outcome.quality of life score

Contacts

Primary ContactYayi He
doctorjael@foxmail.com862165115006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026