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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery plus post-surgery chemotherapy

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Surgery plus post-surgery chemotherapy

Surgery combined with rAd-p53 gene therapy

Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy

Group Type EXPERIMENTAL

Surgery combined with rAd-p53 gene therapy

Intervention Type DRUG

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

Interventions

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Surgery combined with rAd-p53 gene therapy

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

Intervention Type DRUG

Surgery

Surgery plus post-surgery chemotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No