Status:
NOT_YET_RECRUITING
Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Shenzhen SiBiono GeneTech Co.,Ltd
Conditions:
Multiple Pulmonary Ground-Glass Nodules
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Background: Ground-glass nodules (GGN) are a common manifestation of early-stage lung adenocarcinoma, and their management strategy (active surveillance or surgical intervention) often presents a dile...
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating women.
- History of other active malignancies within the past 5 years.
- Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST \> 3×ULN, Cr \> 1.5×ULN).
- Uncontrolled systemic infection or immunodeficiency diseases.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07150416
Start Date
October 1 2025
End Date
February 1 2027
Last Update
September 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120