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

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Progression

Treatments: Other: Ablation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04905056

B2021-088R

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Experimental group

Treatment:

Other: Ablation therapy