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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced kidney cancer.
By enrolling patients with kidney 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 cryosurgery and nature killer (NK) cells for advanced kidney cancer.
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 |
|---|---|---|---|
| Cryosurgery and NK immunotherapy | Experimental | In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell). |
|
| Cryosurgery | Active Comparator | In this group, the patients will receive comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryosurgery | Device | Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief degree | 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 |
|---|---|---|
| Guifeng Liu, PhD | Fuda Cancer Hospital, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute in Fuda cancer hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| NK immunotherapy | Biological | Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.) |
|
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |