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The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone.
Natural killer cells play an important role in the anti-tumor process mediated by innate immunity. However, past researches showed dissatisfactory clinical outcome in clinicaltrials using autologous NK cell infusion alone. With the expectation that the combination of autologous NK cell infusion and chemotherapy may increase the therapeutic efficiency of chemotherapy alone in cancer treatment, the investigators design and conduct this randomized controlled trial in the treatment of non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK infusion+chemotherapy | Experimental | Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks. |
|
| chemotherapy | Active Comparator | Receive the same taxol and carboplatin in experimental arm without NK cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK cells | Biological | Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9,q28d*4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants responding to treatment | Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival(PFS) time | 2 years | |
| Overall survival time | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for participation in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Qian, MD, PhD | Contact | 0086-023-68765461 | cqian3184@163.com | |
| Zhi Yang, PhD | Contact | 0086-13206140093 | Lystch@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Qian, MD, PhD | Biotherapy Center of Southwest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital of Third Millitary Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | 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 |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Taxol | Drug | 135-175mg/m2,q28d*4 |
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| Carboplatin | Drug | AUC=5,q28d*4 |
|
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |