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Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer

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ClinicalTrials.gov Identifier: NCT02849379
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.

Condition or disease Intervention/treatment Phase
Recurrent Tongue Cancer Device: Cryosurgery Biological: NK immunotherapy Phase 1 Phase 2

Detailed Description:

By enrolling patients with recurrent tongue 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 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Argon-helium cryosurgical system




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): NCT02849379


Locations
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China, Guangdong
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, China, 510665
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: NCT02849379     History of Changes
Other Study ID Numbers: NK-tongue
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: July 2018
Keywords provided by Fuda Cancer Hospital, Guangzhou:
tongue cancer
cryosurgery
NK immunotherapy
Additional relevant MeSH terms:
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Tongue Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Immunologic Factors
Physiological Effects of Drugs