Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors
NCT ID: NCT02857920
Last Updated: 2020-09-14
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
45 participants
INTERVENTIONAL
2016-08-01
2019-08-01
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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Bevacizumab and NK immunotherapy
In this group, the patients will receive regular Bevacizumab treatment in combination with multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Bevacizumab
7.5 mg/kg, i.v, once every 3 weeks (continuous)
NK immunotherapy
Each treatment: 8\~10 billion cells in all, transfusion in 3 times, i.v.
Bevacizumab
In this group, the patients will receive regular Bevacizumab treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Bevacizumab
7.5 mg/kg, i.v, once every 3 weeks (continuous)
Interventions
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Bevacizumab
7.5 mg/kg, i.v, once every 3 weeks (continuous)
NK immunotherapy
Each treatment: 8\~10 billion cells in all, transfusion 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
18 Years
75 Years
ALL
Yes
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-Bevacizumab
Identifier Type: -
Identifier Source: org_study_id
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