This study aims to address the core deficiencies in the field by situating bronchoscopic ablation within the same evidentiary frame as segmentectomy and lobectomy. It will deliver adjusted retrospective comparisons with external validation using population data, a prospective noninferiority evaluation on disease control and safety, quantitative evidence on pulmonary function and quality of life, and translational endpoints linking circulating tumour DNA (ctDNA) dynamics and immune activation to durability of control. The work is directly aligned with Hong Kong service needs, where a safe lung preserving option that shortens recovery and optimises resource use could relieve surgical waiting pressure while maintaining oncologic outcomes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
The study doctor perform robotic-assisted or electromagnetic navigation bronchoscopy to locate the target lung lesion, deliver the ablation catheter through the bronchus to the target site for lesion puncture, and conduct microwave ablation. After the surgery, CBCT scanning is conducted to evaluate the ablation effect, and repeated ablation is performed as needed.
The study doctor will begin by opening the hilar pleural reflection, followed by dissection of and division of lobar / segmental vein and artery by endostaplers. Segmental or lobar bronchus is dissected out and stapled. Lymphadenectomy will be performed and the specimens will be retrieved using protective bags via utility wound. This lung tissue specimen may also be analysed for research purpose.
Prince of Wales Hospital
Hong Kong, Hong Kong
Disease-Free Survival (DFS) at 24 Months
To determine whether bronchoscopic microwave ablation is non-inferior to segmentectomy or lobectomy with respect to disease-free survival (DFS) at 24 months in eligible patients with stage IA lung cancer. DFS is defined as the time from treatment to disease recurrence, progression, or death from any cause.
Time frame: Up to 24 months after treatment
Overall Survival
Comparison of overall survival between treatment groups. OS is defined as the time from treatment to death from any cause.
Time frame: Up to 24 months after treatment
Local Tumor Control Rate
Proportion of participants without local recurrence at the treated lesion site.
Time frame: Up to 24 months after treatment
Time to Recurrence
Time from treatment to first documented local, regional, or distant recurrence.
Time frame: Up to 36 months after treatment
Cancer-Specific Mortality
Death attributable to lung cancer.
Time frame: Up to 36 months after treatment
Major Procedure-Related Complications
Incidence of major complications requiring intervention, hospitalization, or resulting in significant morbidity.
Time frame: 30 days and 90 days after treatment
Procedure-Related Adverse Events
Incidence and severity of treatment-related adverse events.
Time frame: 30 days and 90 days after treatment
Procedure-Related Mortality
Death attributable to the study procedure.
Time frame: 30 days and 90 days after treatment
Forced Expiratory Volume in One Second (FEV1)
Change from baseline in forced expiratory volume in one second (FEV1), percent predicted.
Time frame: 6, 12, 24, and 36 months after treatment and Baseline
Health-Related Quality of Life
Change from baseline in health-related quality of life measured using the EuroQol 5 Dimensions (EQ-5D) questionnaire.
Time frame: 6, 12, 24, and 36 months after treatment and baseline
Functional Exercise Capacity
Change from baseline in six-minute walk distance (Description in questionnaire)
Time frame: 6, 12, 24, and 36 months & Baseline
Return to Usual Activities
Time from treatment until resumption of usual daily activities.
Time frame: Up to 36 months after treatment
Post-Treatment Analgesic Use
Duration and intensity of analgesic medication use following treatment.
Time frame: Up to 36 months after treatment
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO), percent predicted.
Time frame: Baseline; 6, 12, 24, and 36 months after treatment
ctDNA Clearance Rate
Percentage of participants achieving circulating tumor DNA (ctDNA) clearance, defined as the absence of detectable ctDNA in plasma using the study ctDNA assay.
Time frame: Baseline; 1 month and 6 months after treatment
Change in ctDNA Level
Logarithmic fold change in circulating tumor DNA (ctDNA) levels from baseline, measured using the study ctDNA assay
Time frame: Baseline; 1 month and 6 months after treatment
Change in Immune Activation Biomarker Signature Score
Change from baseline in immune activation biomarker signature score, measured using \[specify assay/platform, e.g., RNA sequencing, NanoString immune profiling panel, multiplex immunoassay
Time frame: Baseline and 36 months after treatment
Correlation Between Immune Activation Biomarker Signature Score and Duration of Response
Correlation between immune activation biomarker signature score measured using \[assay/platform\] and duration of response.
Time frame: duration of response assessed up to 36 months after treatment
Correlation Between Immune Activation Biomarker Signature Score and Overall Survival
Correlation between immune activation biomarker signature score measured using \[assay/platform\] and overall survival
Time frame: assessed up to 36 months after treatment
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