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Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Primary Purpose

Stage IA Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Sponsored by
Hangzhou Broncus Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age greater than 18 years. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent. Exclusion Criteria: Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time. Patients with severe pulmonary fibrosis and pulmonary hypertension. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time. Patients with poorly controlled malignant pleural effusion. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation. Eastern Cooperative Oncology Group (ECOG) score > 2. Combined with other tumors with extensive metastasis, expected survival < 6 months. Patients with episodic psychosis. Patients with implantable electronic devices (such as pacemaker or defibrillator). Pregnant women, or patients who have pregnancy plans during the study. Participation or ongoing participation in another clinical study within the past 30 days. Other situations that the investigator deems inappropriate to participate in this study.

Sites / Locations

  • Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transbronchial group

Transthoracic group

Arm Description

Subjects receive bronchoscopy-guided RFA and undergo follow-up.

Subjects receive CT-guided RFA and undergo follow-up.

Outcomes

Primary Outcome Measures

Complete ablation rate at 6 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.

Secondary Outcome Measures

Technical success rate
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Complete ablation rate 12 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Local control rate at 1 year, 2 years and 3 years after ablation
It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.
Progression free survival (PFS)
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
Overall survival (OS)
It is defined as the total time from the ablation to the death of the subject.
Safety
To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Hangzhou Broncus Medical Co., Ltd.
Collaborators
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06052098
Brief Title
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
Official Title
Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Broncus Medical Co., Ltd.
Collaborators
Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Detailed Description
This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transbronchial group
Arm Type
Experimental
Arm Description
Subjects receive bronchoscopy-guided RFA and undergo follow-up.
Arm Title
Transthoracic group
Arm Type
Experimental
Arm Description
Subjects receive CT-guided RFA and undergo follow-up.
Intervention Type
Device
Intervention Name(s)
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Intervention Description
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
Intervention Type
Device
Intervention Name(s)
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Intervention Description
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Primary Outcome Measure Information:
Title
Complete ablation rate at 6 months after ablation
Description
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Time Frame
Immediately after ablation
Title
Complete ablation rate 12 months after ablation
Description
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Time Frame
12 months
Title
Local control rate at 1 year, 2 years and 3 years after ablation
Description
It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.
Time Frame
1 year, 2 years and 3years
Title
Progression free survival (PFS)
Description
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
Time Frame
3 years
Title
Overall survival (OS)
Description
It is defined as the total time from the ablation to the death of the subject.
Time Frame
3 years
Title
Safety
Description
To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent. Exclusion Criteria: Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time. Patients with severe pulmonary fibrosis and pulmonary hypertension. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time. Patients with poorly controlled malignant pleural effusion. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation. Eastern Cooperative Oncology Group (ECOG) score > 2. Combined with other tumors with extensive metastasis, expected survival < 6 months. Patients with episodic psychosis. Patients with implantable electronic devices (such as pacemaker or defibrillator). Pregnant women, or patients who have pregnancy plans during the study. Participation or ongoing participation in another clinical study within the past 30 days. Other situations that the investigator deems inappropriate to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, MD, PhD
Phone
86-021-22200000
Ext
1511
Email
xkyyjysun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Phone
86-021-22200000
Ext
1511
Email
xkyyjysun@163.com
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

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