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Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT02849366
Collaborator
Shenzhen Hank Bioengineering Institute (Other)
30
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryosurgery
  • Biological: NK immunotherapy
 Phase 1/Phase 2

Detailed Description

By enrolling patients with recurrent sarcoma 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 cryosurgery and natural killer (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 :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Device: Cryosurgery
Percutaneous ablation under CT or ultrasound guidance
Other Names:
  • Argon-helium cryosurgical system

    • Biological: NK immunotherapy
    Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
    Active Comparator: 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).

    Device: Cryosurgery
    Percutaneous ablation under CT or ultrasound guidance
    Other Names:
  • Argon-helium cryosurgical system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relief degree [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 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 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

    • Principal Investigator: Jibing Chen, MD, PhD, Fuda Cancer Hospital, Guangzhou

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fuda Cancer Hospital, Guangzhou
    ClinicalTrials.gov Identifier:
    NCT02849366
    Other Study ID Numbers:
    • NK-sarcoma
    First Posted:
    Jul 29, 2016
    Last Update Posted:
    Sep 12, 2019
    Last Verified:
    Jul 1, 2018
    Keywords provided by Fuda Cancer Hospital, Guangzhou
    Sarcoma
    Cryosurgery
    NK Immunotherapy
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Sep 12, 2019