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Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy | Experimental | Subjects receive autologous cytokine-induced killer cell infusion every 21 days |
|
| Pemetrexed | Active Comparator | Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cytokine-induced killer cell | Biological | Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Two years | |
| Toxicities | Two years | |
| Quality-of-life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heming Lu, M.D | Contact | 86-771-218-6503 | luhming3632@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guosheng Feng, M.D | People's Hospital of Guangxi Zhuang Autonomous Region | Principal Investigator |
| Hui Lin, M.D | People's Hospital of Guangxi Zhuang Autonomous Region | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530021 | China |
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| Pemetrexed | Other | Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Two years |
| Yuan Liang, M.D |
| Guangxi Department of Public Health |
| Study Chair |
| Heming Lu, M.D | People's Hospital of Guangxi Zhuang Autonomous Region | Study Chair |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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