Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02805829|
Recruitment Status : Unknown
Verified June 2016 by Junnian Zheng, Xuzhou Medical University.
Recruitment status was: Not yet recruiting
First Posted : June 20, 2016
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Trastuzumab + NK cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Trastuzumab With Expanded NK Cells for Treating HER2-positive Gastric Cancer|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Trastuzumab + NK cells
On Cycle 1,day -2, patients will receive IV loading dose 8mg/Kg trastuzumab, followed by collection blood on day 0. After NK expansion and verification that the resulting NK cells meet release criteria, NK cells were washed and resuspended in isotonic sodium chloride for intravenous transfusion on day 14.
NK cellular therapy conduct 2 cycles per year. The maintenance dose of trastuzumab monotherapy is 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
Drug: Trastuzumab + NK cells
NK cellular therapy conduct 2 cycles per year. Herceptin initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
Other Name: Herceptin
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years ]
- Number of Participants with tumor recurrence metastasis as a Measure of effectiveness [ Time Frame: 2 years ]
- T cell subsets figures [ Time Frame: 12 weeks ]
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): NCT02805829
|Contact: Junnian Zheng, MDfirstname.lastname@example.org|
|Contact: Huizhong Li, MMemail@example.com|
|Xuzhou medical university|
|Xuzhou, Jiangsu, China, 221002|
|Principal Investigator:||Junnian Zheng, MD||Xuzhou Medical University|