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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).
60 patients with stage Ⅲb~Ⅳ NSCLC will be randomly divided into group A(receive D-CIK treatment and chemotherapy) or group B(just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-CIK | Experimental | After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment. |
|
| Chemotherapy | Active Comparator | After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Quality of life (QOL) | The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30). | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang P Wang, Physician | Contact | +86 13810661960 | WangGP@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi Z Zhang, Professor | Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Tumor Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510010 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Cisplatin | Drug | Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks. |
|
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| D-CIK | Biological | 8×10^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32. |
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| Phenotypic analysis of T cells | The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell | 1 year |
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) | 1 year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |