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Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors

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ClinicalTrials.gov Identifier: NCT02853903
Recruitment Status : Unknown
Verified July 2016 by Fuda Cancer Hospital, Guangzhou.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The aim of this study is the efficacy of autogenic and allogenic natural killer (NK) immunotherapy on recurrent solid tumors.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumour Biological: NK immunotherapy Phase 2

Detailed Description:
By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this study will document for the first time the short/long term efficacy of auto/allogenic NK cells.The outcome will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Allogenic NK immunotherapy
In this group, the patients will receive more than 4 times of allogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Biological: NK immunotherapy
Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.

Active Comparator: Autogenic NK immunotherapy
In this group, the patients will receive more than 4 times of autogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Biological: NK immunotherapy
Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.




Primary Outcome Measures :
  1. Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)


Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
  2. Overall survival(OS) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853903


Contacts
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Contact: Jibing Chen, MD, PhD +86-13068872049 jibingchen398@163.com

Locations
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China, Guangdong
Fuda cancer institute of Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Jibing Chen, MD, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
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Principal Investigator: Jibing Chen, MD, PhD Fuda Cancer Hospital, Guangzhou

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02853903     History of Changes
Other Study ID Numbers: Auto-allo NK
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016

Keywords provided by Fuda Cancer Hospital, Guangzhou:
solid tumor
NK immunotherapy

Additional relevant MeSH terms:
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Neoplasms
Immunologic Factors
Physiological Effects of Drugs