Stage IA NSCLC
Conditions
Keywords
Bronchoscopic ablation, Robotic assisted bronchoscopy, Image guided ENB, Stage IA NSCLC, disease-free survival
Brief summary
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.
Interventions
PROCEDUREBronchoscopic Microwave Ablation
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.
PROCEDURESurgical Resection
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Bronchoscopic Microwave Ablation Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. 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 4. Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT 5. Tumour located in the middle or peripheral third of the lung parenchyma 6. Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required 7. Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols 8. 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 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Exclusion criteria
1. Presence of lymph node involvement (N1 or higher) or distant metastases (M1) 2. Centrally located tumours within the inner third of the lung or those requiring ablation near major airways 3. Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved 4. Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation 5. Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging 6. Pregnant or breastfeeding women 7. Inability or unwillingness to comply with study procedures 8. Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy 9. Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4 10. Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study Surgical Resection Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection. 4. 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. 5. Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins. 6. Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging. 7. Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging. 8. Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) at 24 Months | Up to 24 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 24 months after treatment | Comparison of overall survival between treatment groups. OS is defined as the time from treatment to death from any cause. |
| Local Tumor Control Rate | Up to 24 months after treatment | Proportion of participants without local recurrence at the treated lesion site. |
| Time to Recurrence | Up to 36 months after treatment | Time from treatment to first documented local, regional, or distant recurrence. |
| Cancer-Specific Mortality | Up to 36 months after treatment | Death attributable to lung cancer. |
| Major Procedure-Related Complications | 30 days and 90 days after treatment | Incidence of major complications requiring intervention, hospitalization, or resulting in significant morbidity. |
| Procedure-Related Adverse Events | 30 days and 90 days after treatment | Incidence and severity of treatment-related adverse events. |
| Procedure-Related Mortality | 30 days and 90 days after treatment | Death attributable to the study procedure. |
| Forced Expiratory Volume in One Second (FEV1) | 6, 12, 24, and 36 months after treatment and Baseline | Change from baseline in forced expiratory volume in one second (FEV1), percent predicted. |
| Health-Related Quality of Life | 6, 12, 24, and 36 months after treatment and baseline | Change from baseline in health-related quality of life measured using the EuroQol 5 Dimensions (EQ-5D) questionnaire. |
| Functional Exercise Capacity | 6, 12, 24, and 36 months & Baseline | Change from baseline in six-minute walk distance (Description in questionnaire) |
| Return to Usual Activities | Up to 36 months after treatment | Time from treatment until resumption of usual daily activities. |
| Post-Treatment Analgesic Use | Up to 36 months after treatment | Duration and intensity of analgesic medication use following treatment. |
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Baseline; 6, 12, 24, and 36 months after treatment | Change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO), percent predicted. |
| ctDNA Clearance Rate | Baseline; 1 month and 6 months after treatment | Percentage of participants achieving circulating tumor DNA (ctDNA) clearance, defined as the absence of detectable ctDNA in plasma using the study ctDNA assay. |
| Change in ctDNA Level | Baseline; 1 month and 6 months after treatment | Logarithmic fold change in circulating tumor DNA (ctDNA) levels from baseline, measured using the study ctDNA assay |
| Change in Immune Activation Biomarker Signature Score | Baseline and 36 months after treatment | Change from baseline in immune activation biomarker signature score, measured using \[specify assay/platform, e.g., RNA sequencing, NanoString immune profiling panel, multiplex immunoassay |
| Correlation Between Immune Activation Biomarker Signature Score and Duration of Response | duration of response assessed up to 36 months after treatment | Correlation between immune activation biomarker signature score measured using \[assay/platform\] and duration of response. |
| Correlation Between Immune Activation Biomarker Signature Score and Overall Survival | assessed up to 36 months after treatment | Correlation between immune activation biomarker signature score measured using \[assay/platform\] and overall survival |
Countries
Hong Kong
Contacts
CONTACTCalvin Sze Hang Ng
PRINCIPAL_INVESTIGATORCalvin Sze Hang Ng
CUHK
Outcome results
None listed