Bronchoscopic Microwave Intervention Treatment in Advance... | NCT04360655

Studies
Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

NCT04360655

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Effect Increased
Safety Issues

Interventions

bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Caicun Zhou, Director, Head of Oncology, Principal Investigator, Clinical Professor, Shanghai Pulmonary Hospital, Shanghai, ChinaPrincipal Investigator

Lead Sponsor

Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy	Active Comparator	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy	Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
combined with bronchoscopic microwave intervention	Experimental	anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention	Procedure: bronchoscopic microwave intervention Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchoscopic microwave intervention	Procedure	bronchoscopic microwave intervention	combined with bronchoscopic microwave intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
objective response rate	objective response rate	6 weeks
progression-free survival	progression-free survival	1 years

Secondary Outcomes

Measure	Description	Time Frame
disease control rate	disease control rate	6 weeks
overall survival	overall survival	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

contraindications to tracheoscopy, chemotherapy, and immunotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yayi He	Contact	862165115006	3056	doctorjael@foxmail.com

Overall Officials

Name	Affiliation	Role
Caicun Zhou, MD, PHD	Shanghai Pulmonary Hospital, Shanghai, China	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004358	Drug Therapy
D020360	Neoadjuvant Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D003131	Combined Modality Therapy

Browse Leaves

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Browse Branches

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