- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360655
Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC
April 22, 2020 updated by: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
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
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
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yayi He
- Phone Number: 3056 862165115006
- Email: doctorjael@foxmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy
Exclusion Criteria:
- contraindications to tracheoscopy, chemotherapy, and immunotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
|
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Other Names:
|
Experimental: combined with bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
|
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Other Names:
bronchoscopic microwave intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate
Time Frame: 6 weeks
|
objective response rate
|
6 weeks
|
progression-free survival
Time Frame: 1 years
|
progression-free survival
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2 years
|
overall survival
|
2 years
|
disease control rate
Time Frame: 6 weeks
|
disease control rate
|
6 weeks
|
adverse events
Time Frame: 3 weeks
|
adverse events
|
3 weeks
|
quality of life score
Time Frame: World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100,higher scores mean a better outcome.
|
quality of life score
|
World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100,higher scores mean a better outcome.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Caicun Zhou, MD, PHD, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
April 30, 2022
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 22, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Surpass
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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