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Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02843581
Recruitment Status : Completed
First Posted : July 26, 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 advanced esophageal cancer.

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

Detailed Description:

By enrolling patients with pancreatic 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 nature killer (NK) cells for advanced esophageal cancer.

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 : 60 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
We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors
Device: Cryosurgery
Argon-helium cryosurgical system

Biological: NK immunotherapy
Nutral killer cell immunotherapy for more than 6 times

Active Comparator: Cryosurgery
We use comprehensive cryosurgery to destroy big tumors
Device: Cryosurgery
Argon-helium cryosurgical system




Primary Outcome Measures :
  1. Relief degree [ 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): NCT02843581


Locations
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China, Guangdong
Fuda cancer institute in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
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Principal Investigator: Guifeng Liu, PhD Fuda Cancer Hospital, Guangzhou

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02843581     History of Changes
Other Study ID Numbers: NK-esopha
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Esophageal Cancer
NK immunotherapy
Safety
Efficacy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Immunologic Factors
Physiological Effects of Drugs