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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery plus post-surgery chemotherapy | Active Comparator | Surgery plus post-surgery chemotherapy |
|
| Surgery combined with rAd-p53 gene therapy | Experimental | Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery combined with rAd-p53 gene therapy | Drug | Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | determine the 3-years overall survival | 3 year after the treatment |
| adverse effects | from starting treatment to 30 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| local recurrent rate | 3 years | |
| quality of life | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunyou Tan, M.D., Ph.D | Contact | 13983770929 | 13983770929@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qunyou Tan, M.D., Ph.D | Institute of Surgery Research, Daping Hospital, Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Surgery Research, Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 40042 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | Surgery plus post-surgery chemotherapy |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |