Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Grou… (NCT07150416) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study
China38 participantsStarted 2025-10-01
Plain-language summary
This study aims to evaluate the safety and efficacy of nebulized inhalation of Recombinant Human Ad-p53 Injection (Gendicine®) for the treatment of multiple ground-glass lung nodules. This is a single-arm, open-label clinical study conducted at The First Affiliated Hospital of Guangzhou Medical University in China. We plan to enroll approximately 38 patients who have been diagnosed with multiple ground-glass nodules. All participants in this study will receive the nebulized Gendicine® treatment. After the treatment, we will monitor changes in the nodules through regular chest CT scans and record any potential treatment-related reactions to determine if this novel therapy is safe and effective. This study has been approved by the hospital's Ethics Committee.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years.
. CT scan confirms the presence of multiple ground-glass nodules (GGNs), with at least one nodule measuring between 0.5 cm and 3.0 cm in diameter.
. At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.
. Life expectancy ≥ 12 weeks.
. Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).
. Signed informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 6 months after the first dose of intervention
Trial details
NCT IDNCT07150416
SponsorThe First Affiliated Hospital of Guangzhou Medical University