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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

determine the 3-years overall survival

Outcome Time Frame:

3 year after the treatment

Safety Issue:

No

Principal Investigator

Qunyou Tan, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Surgery Research, Daping Hospital, Third Military Medical University

Authority:

China: Military Health Department

Study ID:

rAd-p53NSCLC

NCT ID:

NCT01574729

Start Date:

August 2012

Completion Date:

October 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • p53 gene therapy
  • non-small cell lung cancer
  • post-surgery
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Li-Fraumeni Syndrome

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