Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer

Study Overview
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Brief Summary
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The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.

Detailed Description
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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).

Conditions
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Recurrent Tongue Cancer

Intervention / Treatment
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* Device: Cryosurgery
* Biological: NK immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence Body tumor 1-6, the maximum tumor length < 5 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryosurgery and NK immunotherapy<br>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). | Device: Cryosurgery<br>* Percutaneous ablation under CT or ultrasound guidance<br>* Other names: Argon-helium cryosurgical system;Biological: NK immunotherapy<br>* Each treatment: 8 10 billion cells in all, transfuion in 3 times, i.v.<br>|
| Active Comparator: Cryosurgery<br>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). | Device: Cryosurgery<br>* Percutaneous ablation under CT or ultrasound guidance<br>* Other names: Argon-helium cryosurgical system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree of tumors | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） |  | 1 year | 
| Overall survival（OS） |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tongue cancer, cryosurgery, NK immunotherapy