[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604507":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Recombinant Human Ad-p53 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Recombinant Human Ad-p53 Injection","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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jianxing He, Ph.D","CONTACT","86+020-83062807","drjianxing.he@gmail.com",[28],{"facility":5,"status":20,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Guangzhou","Guangdong","510120","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":44},"Hengrui Liang, M.D.","+86 15625064712","hengrui_liang@163.com",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jianxing He","Principal Investigator, Department of Thoracic Surgery",[50],{"name":51,"class":52},"Shenzhen SiBiono GeneTech Co.,Ltd","INDUSTRY","100604507","phase-2-nebulized-inhalation-of-recombinant-human-p53-adenovirus-injection-for-treatment-of-multiple-ground-glass-lung-nodules-a-single-arm-clinical-study-100604507",false,"NCT07150416","Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study","A Single-Arm Clinical Study of Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine) for Treatment of Multiple Ground-Glass Lung Nodules","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. 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.\n3. At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.\n4. Life expectancy ≥ 12 weeks.\n5. Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. History of other active malignancies within the past 5 years.\n3. Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III\u002FIV heart failure, ALT\u002FAST \\> 3×ULN, Cr \\> 1.5×ULN).\n4. Uncontrolled systemic infection or immunodeficiency diseases.\n5. Participation in another interventional clinical trial within 4 weeks prior to enrollment.\n6. Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.","ALL","18 Years",{"count":63,"type":64},38,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","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.",[70,71,72],"Multiple Pulmonary Ground-Glass Nodules","Lung Neoplasms","Precancerous Conditions",[74,75,76,77],"p53 gene therapy","nebulized inhalation","Gendicine","Single-Arm Trial","NOT_YET_RECRUITING","2025-08-25",{"date":81,"type":82},"2025-09-02","ACTUAL",{"date":84,"type":64},"2025-10-01",{"date":86,"type":64},"2027-02-01",{"name":5,"class":6},1]