Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Bronchoscopic 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.
• Процедура Surgical 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.

Первичные конечные точки

• Disease-Free Survival (DFS) at 24 Months [Срок оценки: Up to 24 months after treatment]

Вторичные конечные точки (12)

• Overall Survival [Срок оценки: Up to 24 months after treatment]
• Local Tumor Control Rate [Срок оценки: Up to 24 months after treatment]
• Time to Recurrence [Срок оценки: Up to 36 months after treatment]
• Cancer-Specific Mortality [Срок оценки: Up to 36 months after treatment]
• Major Procedure-Related Complications [Срок оценки: 30 days and 90 days after treatment]
• Procedure-Related Adverse Events [Срок оценки: 30 days and 90 days after treatment]
• Procedure-Related Mortality [Срок оценки: 30 days and 90 days after treatment]
• Forced Expiratory Volume in One Second (FEV1) [Срок оценки: 6, 12, 24, and 36 months after treatment and Baseline]
• Health-Related Quality of Life [Срок оценки: 6, 12, 24, and 36 months after treatment and baseline]
• Functional Exercise Capacity [Срок оценки: 6, 12, 24, and 36 months & Baseline]
• Return to Usual Activities [Срок оценки: Up to 36 months after treatment]
• Post-Treatment Analgesic Use [Срок оценки: Up to 36 months after treatment]

Критерии участия

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

Критерии исключения

• 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
• 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
• Pregnant or breastfeeding women
• Inability or unwillingness to comply with study procedures
• Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy
• Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4
• Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study

Surgical Resection Group Inclusion Criteria

• Adults aged ≥18 years
• Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
• 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.
• Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging.
• 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

Критерии исключения

• Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
• High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred.
• Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins).
• Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection.
• Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study.
• Pregnant or breastfeeding women
• Inability or unwillingness to comply with study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT07741344 · 2026.005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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