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Combination of Cryosurgey and NK Immunotherapy for Recurrent Laryngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849314
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

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2016)		 Relief degree of tumors [ Time Frame: 3 months ]
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02849314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
  • Progress free survival（PFS） [ Time Frame: 1 year ]
  • Overall survival（OS） [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Cryosurgey and NK Immunotherapy for Recurrent Laryngeal Cancer
Official Title  ICMJE Not Provided
Brief Summary The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent laryngeal cancer.
Detailed Description

By enrolling patients with recurrent laryngeal 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Laryngeal Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Interventions:
    • Device: Cryosurgery
    • Biological: NK immunotherapy
  • 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).
    Intervention: Device: Cryosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2016)		 30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849314
Other Study ID Numbers  ICMJE NK-Larynx
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Shenzhen Hank Bioengineering Institute
Investigators  ICMJE
Principal Investigator: Jibing Chen, MD, PhD Fuda Cancer Hospital, Guangzhou
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP