Back to resultsHigh-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer
Primary Purpose
Tongue Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
High-activity natural killer
Sponsored by
About this trial
This is an interventional treatment trial for Tongue Cancer focused on measuring Metastatic tongue cancer, High-activity natural killer
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 < 2 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
No Intervention
Arm Label
High-activity natural killer
Control
Arm Description
In this group, the patients will receive multiple high-activity natural killer (HANK) 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 no special treatment and as a control group. 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
NCT03008330
First Posted
December 30, 2016
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
1. Study Identification
Unique Protocol Identification Number
NCT03008330
Brief Title
High-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
June 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 high-activity natural killer immunotherapy to small metastases of tongue cancer.
Detailed Description
By enrolling patients with small metastases of tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer 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
Tongue Cancer
Keywords
Metastatic tongue cancer, High-activity natural killer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-activity natural killer
Arm Type
Experimental
Arm Description
In this group, the patients will receive multiple high-activity natural killer (HANK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention Type
Biological
Intervention Name(s)
High-activity natural killer
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
60 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 < 2 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
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
High-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer
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