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

Shanghai Zhongshan Hospital1 site in 1 country120 target enrollmentJanuary 1, 2021

ConditionsProgression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Progression
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: progression free survival
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 1, 2021

End Date

December 31, 2028

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Principal Investigator

Xi Junjie

professor

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

•Aged between 18 and 85 years;
•GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
•The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
•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
•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
•The patient is able to understand and comply with the study and has provided written informed consent

Exclusion Criteria

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