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

ConditionProgression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Zhongshan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ablation therapy

    Other intervention

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: ablation therapy in the treatment of lung cancer presenting as ground-glass nodulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression free survival

One year progression free survival after radiofrequency ablation of ground glass nodules

Time frame
1 years

Secondary outcomes

1

overall survival

overall survival after radiofrequency ablation of ground glass nodules

Time frame
1 years, 3 years, 5years

Other outcomes

Sponsors and contacts

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