Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04360655
• Other study ID #: Surpass
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2020
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He
• Phone: 862165115006
• Email: doctorjael[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contraindications to tracheoscopy, chemotherapy, and immunotherapy

Related Conditions & MeSH terms

• Effect Increased
• Safety Issues

Intervention

Procedure:
• bronchoscopic microwave intervention
bronchoscopic microwave intervention

Drug:
• anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	objective response rate	6 weeks
Primary	progression-free survival	progression-free survival	1 years
Secondary	disease control rate	disease control rate	6 weeks
Secondary	overall survival	overall survival	2 years
Secondary	adverse events	adverse events	3 weeks
Secondary	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.