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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 recurrent tongue cancer.
By enrolling patients with recurrent tongue 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 natural killer (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 |
|---|---|---|---|
| Cryosurgery and NK immunotherapy | Experimental | In this group, the patients will receive comprehensive cryosurgery to clear all big tumors and then receive multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Cryosurgery | Active Comparator | In this group, the patients will receive comprehensive cryosurgery to clear all big tumors. 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 |
|---|---|---|---|---|
| Cryosurgery | Device | Percutaneous ablation under CT or ultrasound guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief degree of tumors | 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 of Fuda cancer hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| NK immunotherapy | Biological | Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v. |
|
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014060 | Tongue Diseases |