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Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT03008343
Collaborator
Shenzhen Hank Bioengineering Institute (Other)
20
Enrollment
1
Location
2
Arms
30.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus natural killer (NK) immunotherapy to recurrent liver cancer.

Condition or Disease Intervention/Treatment Phase
  • Device: Irreversible Electroporation
  • Biological: Natural killer
 Phase 1/Phase 2

Detailed Description

By enrolling patients with recurrent liver 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 IRE and 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electroporation and natural killer

In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Irreversible Electroporation
One kind of electric ablation machine from Angiodynamic company (USA)
Other Names:
  • IRE, NanoKnife

    • Biological: Natural killer
    Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
    Other Names:
  • HANK cell

    		•
    Active Comparator: Electroporation

    In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

    Device: Irreversible Electroporation
    One kind of electric ablation machine from Angiodynamic company (USA)
    Other Names:
  • IRE, NanoKnife

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relief degree of tumors [3 months]

      It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

    Secondary Outcome Measures

    1. Progress free survival（PFS） [1 year]

    2. Overall survival（OS） [3 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuda cancer institute of Fuda cancer hospital Guangzhou Guangdong China 510665

    Sponsors and Collaborators

    • Fuda Cancer Hospital, Guangzhou
    • Shenzhen Hank Bioengineering Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fuda Cancer Hospital, Guangzhou
    ClinicalTrials.gov Identifier:
    NCT03008343
    Other Study ID Numbers:
    • IRE-NK-Liver
    First Posted:
    Jan 2, 2017
    Last Update Posted:
    Sep 12, 2019
    Last Verified:
    Dec 1, 2018
    Keywords provided by Fuda Cancer Hospital, Guangzhou
    Irreversible Electroporation
    NK Immunotherapy
    Recurrent Liver Carcinoma
    Additional relevant MeSH terms:
    Carcinoma, Hepatocellular
    Recurrence

    Study Results

    No Results Posted as of Sep 12, 2019