NCT07005999

Interventional Ablation for Early-stage Lung Cancer

The Safety and Efficacy of Interventional Ablation for High-risk Pulmonary Nodules or Early-stage Lung Cancer: A Multicenter, Prospective, Real-World Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 656 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function. Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function. Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.

Detailed description

What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function. Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function. Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease. Who can participate? Adults aged 20-79 with high-risk lung nodules or early lung cancer. Eligibility criteria: Nodules ≤2 cm on CT scan, no lymph node/distant spread. Good overall health (e.g., normal blood/organ function, no severe heart/lung disease). No recent cancer treatments (e.g., chemotherapy, radiation). Exclusions: Nodules near major blood vessels/chest wall, pregnancy, or uncontrolled medical conditions. What does the study involve? Two treatment groups: Ablation group: Destroy tumors using heat (microwave) or cold (cryoablation). Surgery group: Remove tumors via standard surgery. Follow-up: Regular check-ups for 5 years, including CT scans, lung function tests, and blood work. What are the potential risks? Ablation risks: Pain, bleeding, infection, pneumothorax (collapsed lung), or damage to nearby organs. Surgery risks: Infection, prolonged pain, lung complications (e.g., reduced function), or longer recovery. Both groups may experience recurrence or side effects like fatigue. What are the benefits? Direct benefits: Access to advanced treatments, close monitoring, and potential lung function preservation with ablation. Long-term impact: Help future patients by improving treatment options for early lung cancer. Study Timeline and Locations Duration: 2024-2028 (participants followed for up to 5 years). Locations: 18+ major hospitals across China, including Guangzhou Medical University Affiliated Hospital (lead center), West China Hospital, and Shanghai Chest Hospital. Key Outcomes Measured Relapse-free survival: Time without cancer returning. Safety: Rates of complications (e.g., bleeding, infection). Lung function: Preserved breathing capacity after treatment. Quality of life: Physical and emotional well-being post-treatment. How will results be used? Findings will guide doctors in choosing the best treatment for early lung cancer, balancing effectiveness with quality of life. Results will be published in medical journals and shared at conferences. Contact Information For questions or enrollment: Lead Researcher: Dr. Zhou Chengzhi, Respiratory Medicine, Guangzhou Medical University Affiliated Hospital. Local Sites: Contact participating hospitals listed in the study document. Ethical Approval: This study follows strict ethical guidelines to protect participants. All treatments are voluntary, and participants may withdraw at any time.

Conditions

• Lung Cancer (NSCLC)
• Early Stage Lung Non-Small Cell Carcinoma

Timeline

• Start date: 2025-04-12
• Primary completion: 2028-12-21
• Completion: 2028-12-31
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: China