Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

NCT ID: NCT04360655

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Effect Increased Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

combined with bronchoscopic microwave intervention

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

Group Type EXPERIMENTAL

bronchoscopic microwave intervention

Intervention Type PROCEDURE

bronchoscopic microwave intervention

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

Intervention Type DRUG

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

Interventions

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bronchoscopic microwave intervention

bronchoscopic microwave intervention

Intervention Type PROCEDURE

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

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

Intervention Type DRUG

Other Intervention Names

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Local treatment Systemic treatment

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* contraindications to tracheoscopy, chemotherapy, and immunotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Caicun Zhou

Director, Head of Oncology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caicun Zhou, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Central Contacts

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Yayi He

Role: CONTACT

862165115006 ext. 3056

Other Identifiers

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Surpass

Identifier Type: -

Identifier Source: org_study_id

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