NCT01574729: rAd-p53

Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

Status unknown Phase 2 Last updated 27 June 2012

What this trial tests

Phase 2 trial testing Surgery combined with rAd-p53 gene therapy in Non-small Cell Lung Cancer in 120 participants. Status unknown.

Timeline

1 August 2012

Primary endpoint
1 August 2015

1 October 2015

Quick facts

Lead sponsor	Shenzhen SiBiono GeneTech Co.,Ltd
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 August 2012
Primary completion	1 August 2015
Estimated completion	1 October 2015
Sites	1 location across China

Drugs / interventions tested

• Surgery combined with rAd-p53 gene therapy — full drug profile →
• Surgery

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• overall survival
  Time frame: 3 year after the treatment
  determine the 3-years overall survival
• adverse effects
  Time frame: from starting treatment to 30 days after treatment

Sponsor's own description

The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.

The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lung cancer immunotherapy: progress, pitfalls, and promises.
   Lahiri A, Maji A, Potdar PD, Singh N, et al · · 2023 · cited 737× · PMID 36810079 · DOI 10.1186/s12943-023-01740-y
2. p53: From Fundamental Biology to Clinical Applications in Cancer.
   Capuozzo M, Santorsola M, Bocchetti M, Perri F, et al · · 2022 · cited 49× · PMID 36138802 · DOI 10.3390/biology11091325
3. Genomic profiling toward precision medicine in non-small cell lung cancer: getting beyond EGFR.
   Richer AL, Friel JM, Carson VM, Inge LJ, et al · · 2015 · cited 27× · PMID 25897257 · DOI 10.2147/pgpm.s52845
4. From regulation to deregulation of p53 in hematologic malignancies: implications for diagnosis, prognosis and therapy.
   Ahmadi SE, Rahimian E, Rahimi S, Zarandi B, et al · · 2024 · cited 15× · PMID 39538363 · DOI 10.1186/s40364-024-00676-9
5. Surgery combined with adenoviral p53 gene therapy for treatment of non-small cell lung cancer: a phase II study.
   Deng B, Sun T, Tang B, Tao S, et al · · 2017 · cited 7× · PMID 29291013 · DOI 10.18632/oncotarget.22333
6. Paracrine Regulation and Immune System Pathways in the Inflammatory Tumor Microenvironment of Lung Cancer: Insights into Oncogenesis and Immunotherapeutic Strategies.
   Batrash F, Shaik A, Rauf R, Kutmah M, et al · · 2024 · cited 4× · PMID 38539448 · DOI 10.3390/cancers16061113
7. The emerging nanomedicine-based technology for non-small cell lung cancer immunotherapy: how far are we from an effective treatment.
   Peng L, Xu Q, Yin S, Zhang Y, et al · · 2023 · cited 2× · PMID 37182180 · DOI 10.3389/fonc.2023.1153319
8. Randomized controlled trials in lung cancer surgery: How are we doing?
   Wong LY, Li Y, Elliott IA, Backhus LM, et al · · 2024 · cited 1× · PMID 38690441 · DOI 10.1016/j.xjon.2024.01.008