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
| NCT ID | NCT04905056 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Progression |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2021-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04905056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Progression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04905056 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04905056 currently recruiting?
Yes, NCT04905056 is actively recruiting participants. Contact the research team at 13301050210@fudan.edu.cn for enrollment information.
Where is the NCT04905056 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04905056 clinical trial?
NCT04905056 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 120 participants.