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Recruiting NCT04905056

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 II Interventional Progression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ablation therapy.
Who it may be relevant to
Registry conditions: Progression. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • progression free survival [Time frame: 1 years]
Secondary outcome measures (1)
  • overall survival [Time frame: 1 years, 3 years, 5years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Thoracic Surgery, Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT04905056 · B2021-088R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗