Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study

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.

NCT Number	NCT07150416
Lead Sponsor	The First Affiliated Hospital of Guangzhou Medical University Collaborators: Shenzhen SiBiono GeneTech Co.,Ltd
Conditions	Multiple Pulmonary Ground-Glass Nodules, Lung Neoplasms, Precancerous Conditions
Enrollment	38 participants
Start Date	2025-10-01
Primary Completion	2026-12-01 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-02