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| Name | Class |
|---|---|
| Shanghai Houchao Biotechnology Co., Ltd | UNKNOWN |
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The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEKT cell | Experimental | Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEKT cell | Biological | 3 cycles of HEKT cell treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| safety:safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment | Occurrence of study related adverse events as assessed by CTCAE v4.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy: complete response; partial response; stable disease; progression disease; progression free survival. | The efficacy of the treatment is assessed according to (RECIST1.1) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause. | 2 years |
| Overall survival |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei H Du, M.S | Contact | 13918570392 | sealing821201@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | 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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Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
| 2 years |
| Imaging evaluation before and after treatment | the SUV index of PET-CT before cell injection and after the whole course of the treatment | 0 day and 60 day |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |