Combination of Cryosurgey and NK Immunotherapy for Recurrent Laryngeal Cancer
NCT ID: NCT02849314
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2016-07-01
2019-07-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cryosurgery and NK immunotherapy
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
Percutaneous ablation under CT or ultrasound guidance
NK immunotherapy
Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.
Cryosurgery
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).
Cryosurgery
Percutaneous ablation under CT or ultrasound guidance
Interventions
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Cryosurgery
Percutaneous ablation under CT or ultrasound guidance
NK immunotherapy
Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
40 Years
70 Years
ALL
No
Sponsors
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Shenzhen Hank Bioengineering Institute
OTHER
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Jibing Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fuda Cancer Hospital, Guangzhou
Locations
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Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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NK-Larynx
Identifier Type: -
Identifier Source: org_study_id
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