Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study
NCT ID: NCT07150416
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
38 participants
INTERVENTIONAL
2025-10-01
2027-02-01
Brief Summary
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Detailed Description
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Methods: This is a single-arm, open-label, phase II clinical trial utilizing the Simon's optimal two-stage design. The first stage plans to enroll 16 patients. If ≥1 objective response (according to RECIST 1.1 criteria) is observed, the study will proceed to the second stage, with a total planned enrollment of 30 evaluable patients (38 subjects will be recruited accounting for a 20% dropout rate). Participants are patients with multiple ground-glass nodules confirmed by imaging, with at least one nodule pathologically confirmed as malignant. The intervention is nebulized inhalation of Gendicine® at a dose of 1×10¹² VP per time, administered once every three days, for a total of four times. The primary endpoint is the Objective Response Rate (ORR), defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) at 6 months post-treatment. Secondary endpoints include safety (assessing adverse events according to CTCAE v5.0), changes in tumor markers, and quality of life scores.
Significance: This study is the world's first clinical trial to explore nebulized inhalation of a gene therapy product for the treatment of lung nodules. Positive results would provide a novel, non-invasive treatment strategy for the very early intervention of lung cancer, potentially delaying or preventing nodule malignancy and avoiding surgical trauma.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gendicine Nebulization Arm
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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, adenocarcinoma in situ) by histopathology or cytology.
4. Life expectancy ≥ 12 weeks.
5. Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).
6. Signed informed consent.
Exclusion Criteria
2. History of other active malignancies within the past 5 years.
3. Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST \> 3×ULN, Cr \> 1.5×ULN).
4. Uncontrolled systemic infection or immunodeficiency diseases.
5. Participation in another interventional clinical trial within 4 weeks prior to enrollment.
6. Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.
18 Years
ALL
No
Sponsors
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Shenzhen SiBiono GeneTech Co.,Ltd
INDUSTRY
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Jianxing He
Principal Investigator, Department of Thoracic Surgery
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
Aoki T, Hanamiya M, Uramoto H, Hisaoka M, Yamashita Y, Korogi Y. Adenocarcinomas with predominant ground-glass opacity: correlation of morphology and molecular biomarkers. Radiology. 2012 Aug;264(2):590-6. doi: 10.1148/radiol.12111337. Epub 2012 May 31.
Cheng B, Li C, Li J, Gong L, Liang P, Chen Y, Zhan S, Xiong S, Zhong R, Liang H, Feng Y, Wang R, Wang H, Zheng H, Liu J, Zhou C, Shao W, Qiu Y, Sun J, Xie Z, Liang Z, Yang C, Cai X, Su C, Wang W, He J, Liang W. The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial. Signal Transduct Target Ther. 2024 Apr 19;9(1):93. doi: 10.1038/s41392-024-01799-z.
Pan JJ, Zhang SW, Chen CB, Xiao SW, Sun Y, Liu CQ, Su X, Li DM, Xu G, Xu B, Lu YY. Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Feb 10;27(5):799-804. doi: 10.1200/JCO.2008.18.9670. Epub 2008 Dec 22.
Kastan MB, Canman CE, Leonard CJ. P53, cell cycle control and apoptosis: implications for cancer. Cancer Metastasis Rev. 1995 Mar;14(1):3-15. doi: 10.1007/BF00690207.
Khoo KH, Verma CS, Lane DP. Drugging the p53 pathway: understanding the route to clinical efficacy. Nat Rev Drug Discov. 2014 Mar;13(3):217-36. doi: 10.1038/nrd4236.
Hassin O, Oren M. Drugging p53 in cancer: one protein, many targets. Nat Rev Drug Discov. 2023 Feb;22(2):127-144. doi: 10.1038/s41573-022-00571-8. Epub 2022 Oct 10.
Kruiswijk F, Labuschagne CF, Vousden KH. p53 in survival, death and metabolic health: a lifeguard with a licence to kill. Nat Rev Mol Cell Biol. 2015 Jul;16(7):393-405. doi: 10.1038/nrm4007.
Kim MP, Lozano G. Mutant p53 partners in crime. Cell Death Differ. 2018 Jan;25(1):161-168. doi: 10.1038/cdd.2017.185. Epub 2017 Nov 3.
Mantovani F, Collavin L, Del Sal G. Mutant p53 as a guardian of the cancer cell. Cell Death Differ. 2019 Jan;26(2):199-212. doi: 10.1038/s41418-018-0246-9. Epub 2018 Dec 11.
Other Identifiers
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rAdp53-LN001
Identifier Type: -
Identifier Source: org_study_id
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