Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07150416 | Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study | PHASE2 | NOT YET_RECRUITING | 38 | — | — | Oct 1, 2025 | Feb 1, 2027 | Sep 2, 2025 | 1 | China |
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, based on chest CT scan assessments. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
| Arm | Type | Description |
|---|---|---|
| Gendicine Nebulization Arm | EXPERIMENTAL | Participants in this single arm of the study will all receive the active intervention, which is Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine®), at a dose of 1×10¹² VP per session. The treatment will be administered once every three days, for a total of four sessions. |
| Name | Type | Description |
|---|---|---|
| Recombinant Human Ad-p53 Injection | DRUG | A replication-deficient recombinant human type 5 adenovirus vector encoding the human wild-type p53 tumor suppressor gene. For this study, it will be administered via nebulized inhalation. |
Inclusion Criteria: 1. Age ≥ 18 years. 2. 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. 3. At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarc...