A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

Phase 2

Recruiting

• Conditions: Progression
• Interventions: Other: Ablation therapy

• Registration Number: NCT04905056
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2021-05-23
• Last Update Submitted: 2021-05-23
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Aged between 18 and 85 years;
2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
4. For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
5. The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
6. The patient is able to understand and comply with the study and has provided written informed consent

Exclusion Criteria

1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial
2. had severe disease conditions
3. allergy to narcotic drugs
4. had other autoimmune disease
5. dementia or cognitive impairment can't cooperate with researchers
6. any local treatment other than ablation was received within 4 weeks before the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ablation therapy in the treatment of lung cancer presenting as ground-glass nodules	Ablation therapy	-

Primary Outcome Measures

Name	Time	Method
progression free survival	1 years	One year progression free survival after radiofrequency ablation of ground glass nodules

Secondary Outcome Measures

Name	Time	Method
overall survival	1 years, 3 years, 5years	overall survival after radiofrequency ablation of ground glass nodules

Trial Locations

Locations (1)

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China