Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01574729

Acronym

rAd-p53

Enrollment

120

Registered

2012-04-10

Start date

2012-08-31

Completion date

2015-10-31

Last updated

2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy

Brief summary

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.

Interventions

DRUGSurgery combined with rAd-p53 gene therapy

Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy

PROCEDURESurgery

Surgery plus post-surgery chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* historically diagnosed advanced non-small lung cancer * has surgery indication * age 18 years old or greater * life expectancy greater than 12 weeks * ECOG: 0-2 * no prior chemotherapy, radiotherapy in 2 weeks * Neutrophils≥1.5×10\^9/L,platelet≥80×10\^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range * subject provides signed informed consent

Exclusion criteria

* hypersensitive to study drug * with a coagulational test unnormal or a bleeding disorder * infections * with serious condition which can't stand a surgery * pregnant or lactating * principle investigator consider not suitable

Design outcomes

Primary

Measure	Time frame	Description
overall survival	3 year after the treatment	determine the 3-years overall survival
adverse effects	from starting treatment to 30 days after treatment	—

Secondary

Measure	Time frame
local recurrent rate	3 years
quality of life	3 years

Countries

China

Contacts

Primary ContactQunyou Tan, M.D., Ph.D

13983770929@163.com13983770929

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026