Back to resultsCombination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer
Primary Purpose
Recurrent Tongue Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cryosurgery
NK immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Tongue Cancer focused on measuring tongue cancer, cryosurgery, NK immunotherapy
Eligibility 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
Sites / Locations
- Fuda cancer institute of Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cryosurgery and NK immunotherapy
Cryosurgery
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary Outcome Measures
Progress free survival（PFS）
Overall survival（OS）
Full Information
NCT ID
NCT02849379
First Posted
July 27, 2016
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
1. Study Identification
Unique Protocol Identification Number
NCT02849379
Brief Title
Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
4. Oversight
5. Study Description
Brief Summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Tongue Cancer
Keywords
tongue cancer, cryosurgery, NK immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryosurgery and NK immunotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Cryosurgery
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Cryosurgery
Other Intervention Name(s)
Argon-helium cryosurgical system
Intervention Description
Percutaneous ablation under CT or ultrasound guidance
Intervention Type
Biological
Intervention Name(s)
NK immunotherapy
Intervention Description
Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Primary Outcome Measure Information:
Title
Relief degree of tumors
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progress free survival（PFS）
Time Frame
1 year
Title
Overall survival（OS）
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jibing Chen, MD, PhD
Organizational Affiliation
Fuda Cancer Hospital, Guangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuda cancer institute of Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China
12. IPD Sharing Statement
Learn more about this trial
Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer
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