High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma
NCT ID: NCT03007823
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
20 participants
INTERVENTIONAL
2016-12-01
2019-06-01
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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High-activity natural killer
In this group, the patients will receive multiple high-activity natural killer (HANK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
High-activity natural killer
Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
Control
In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
No interventions assigned to this group
Interventions
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High-activity natural killer
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 \< 2 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
30 Years
60 Years
ALL
No
Sponsors
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Shenzhen Hank Bioengineering Institute
OTHER
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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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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HANK-melanoma
Identifier Type: -
Identifier Source: org_study_id
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