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

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Surgery combined with rAd-p53 gene therapy; Procedure: Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574729

rAd-p53NSCLC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Surgery plus post-surgery chemotherapy

Active Comparator group

Description:

Surgery plus post-surgery chemotherapy

Treatment:

Procedure: Surgery

Surgery combined with rAd-p53 gene therapy

Experimental group

Description:

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

Treatment:

Drug: Surgery combined with rAd-p53 gene therapy