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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.
By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab and NK immunotherapy | Experimental | In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Cetuximab | Active Comparator | In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief degree evaluated by RECIST | It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | 1 year | |
| Overall survival (OS) | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jibing Chen, MD, PhD | Fuda Cancer Hospital, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuda cancer institute in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| NK immunotherapy | Biological | For each procedure, 10 billion cells will be infused in 4 times |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |