High-activity Natural Killer Immunotherapy for Small Metastases of Nasopharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT03007836|
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Nasopharyngeal Cancer||Biological: High-activity natural killer||Phase 1 Phase 2|
By enrolling patients with small metastases of nasopharyngeal 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
Experimental: High-activity natural killer
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).
Biological: High-activity natural killer
Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
No Intervention: Control
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).
- Relief degree of tumors [ Time Frame: 3 months ]It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
- Progress free survival（PFS） [ Time Frame: 1 year ]
- Overall survival（OS） [ Time Frame: 3 years ]
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): NCT03007836
|Fuda cancer institute of Fuda cancer hospital||Recruiting|
|Guangzhou, Guangdong, China, 510665|
|Contact: Jibing Chen, MD, PhD +86-18903068207 firstname.lastname@example.org|