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Clinical Trial Summary

Evaluating the impact of OCTREOTIDE LAR on the immune response by studying Regulatory T-cell (T-Reg) and Myeloid-derived suppressor cells (MDSC) and the immunoregulatory cell population in peripheral blood of NET G1 / G2 patients treated with Octreotide LAR


Clinical Trial Description

MDSCs and T-Regs will be evaluated at baseline pre-treatment with octreotide, after 15 days, at three and at six months and before each octreotide LAR administration for 12 months. MDSC cells will be detected by surface receptors LIN-, CD11b, CD14, CD15, CD33, CD124-IL4-Ra, CD184-CXCR4, CD279-PD1, HLA-DR and T-reg cells from CD3, CD4, CD8 receptors , CD25, CD39, CD45RA, CD45R0, CD62L, CD127, CD152-CTLA-4, CD184-CXCR4, CD278-ICOS, CD279-PD-1. Briefly, CD4 + cells will be separated by negative selection, using the mixture of human CD4 antibodies. Octreotide is currently a registered drug to the FDA, EMA and AIFA with the indication for the treatment of well and moderately differentiated NETs functioning and not working on the front line. . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04129255
Study type Interventional
Source National Cancer Institute, Naples
Contact
Status Completed
Phase Phase 2
Start date June 28, 2017
Completion date December 1, 2019

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