Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Grouā¦ (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 (GendicineĀ®) 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 GendicineĀ® 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 range18 Years
SexALL
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Inclusion criteria
ā. Age ā„ 18 years.
ā. 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.
ā. At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.
ā. Life expectancy ā„ 12 weeks.
ā. Adequate pulmonary function tests (FEV1 ā„ 70% of predicted value).
ā. Signed informed consent.
Exclusion criteria
ā. Pregnant or lactating women.
ā. History of other active malignancies within the past 5 years.
ā. Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST \> 3ĆULN, Cr \> 1.5ĆULN).
ā. Uncontrolled systemic infection or immunodeficiency diseases.
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