High-activity Natural Killer Immunotherapy for Small Metastases of Nasopharyngeal Cancer
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of nasopharyngeal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 30, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 12, 2019
December 1, 2018
1 year
December 30, 2016
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
3 months
Secondary Outcomes (2)
Progress free survival（PFS）
1 year
Overall survival（OS）
3 years
Study Arms (2)
High-activity natural killer
EXPERIMENTALIn 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).
Control
NO INTERVENTIONIn 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).
Interventions
Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, 510665, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2016
First Posted
January 2, 2017
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
June 1, 2019
Last Updated
September 12, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share