Comparing Bronchoscopic Microwave Ablation With Surgery for Early-Stage Non-Small Cell Lung Cancer

Trial details

Who runs it

Chinese University of Hong Kong

Trial code

NCT07741344

Record updated

21 October 2026

Original description

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.Read full original descriptionShow less

A Dual-Phase Study Comparing Survival, Immune Activation, and Functional Preservation Between Robotic-assisted / Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC

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.

Exclusion: Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation; Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging; Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy; Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study; Surgical Resection Group Inclusion Criteria; Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection; Tumour size between 2.5 and 3.0 cm, or smaller lesions for which surgery is considered the more appropriate option based on tumour features or safety concerns; Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins; Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging; Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment; High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred; Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study; Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4; Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection; Adults aged ≥18 years; Presence of lymph node involvement (N1 or higher) or distant metastases (M1); Centrally located tumours within the inner third of the lung or those requiring ablation near major airways; Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved; Pregnant or breastfeeding women; Inability or unwillingness to comply with study procedures; Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm); Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging; Presence of lymph node involvement (N1 or higher) or distant metastases (M1); Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins); Pregnant or breastfeeding women; Inability or unwillingness to comply with study procedures.

Bronchoscopic Microwave Ablation Group Inclusion Criteria; Adults aged ≥18 years; Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm); Determined by multidisciplinary evaluation to be an appropriate candidate for bronchoscopic ablation as part of standard clinical care, and the patient agrees to a lung-preserving treatment approach; Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT; Tumour located in the middle or peripheral third of the lung parenchyma; Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required; Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols; Pulmonary function results or clinical assessment indicate significant benefit from preserving lung tissue, such as predicted FEV1 or DLCO less than 40%, or clinician judgment that lung preservation is critical for quality of life; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

ClinicalTrials.gov NCT07741344