Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Human Ad-p53 Injection.
- Who it may be relevant to
- Registry conditions: Multiple Pulmonary Ground-Glass Nodules, Lung Neoplasms, Precancerous Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-Arm Clinical Study of Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine) for Treatment of Multiple Ground-Glass Lung Nodules
Overview
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.
Detailed description
Background: Ground-glass nodules (GGN) are a common manifestation of early-stage lung adenocarcinoma, and their management strategy (active surveillance or surgical intervention) often presents a dilemma for clinicians and patients. Gendicine® (Recombinant Human Ad-p53 Injection) is a gene therapy product approved in China. Previous studies have shown its ability to induce tumor cell apoptosis and enhance the sensitivity to radiotherapy and chemotherapy in various solid tumors. This study aims to investigate this innovative approach of local administration via nebulized inhalation for treating precancerous lesions or early-stage lung cancer.
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.
Interventions
- 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.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: 6 months after the first dose of intervention]
Secondary outcome measures (1)
- Incidence of Treatment-Related Adverse Events [Time frame: From first dose of study intervention until 30 days after the last dose]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- 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.
- At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.
- Life expectancy ≥ 12 weeks.
- Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).
- Signed informed consent.
Exclusion criteria
- Pregnant or lactating women.
- History of other active malignancies within the past 5 years.
- Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST > 3×ULN, Cr > 1.5×ULN).
- Uncontrolled systemic infection or immunodeficiency diseases.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
Publications
- 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. PMID 35040882
- 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. PMID 22653188
- 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 1 PMID 38637495
- 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. PMID 19103729
- 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. PMID 7606818
- 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. PMID 24577402
- 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. PMID 36216888
- 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. PMID 26122615
Identifiers
NCT: NCT07150416 · rAdp53-LN001