Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction
Status:
Recruiting
Trial end date:
2021-07-14
Target enrollment:
Participant gender:
Summary
RATIONALE: Implant-based reconstruction have become the most popular choices of
reconstruction for women undergoing breast mastectomy. Postoperative complications like
infection and tumor recurrence limit its application. Interferons (IFNs) are pleiotropic
cytokines that involve in immunoregulatory, anticancer and restricting infection. Especially,
type I IFN signaling is reported favourable for the success of conventional
chemotherapeutics, radiotherapy and immunotherapy. In addition, type I IFN can regulate the
activity of almost all immune cell types (including T cells, macrophages and innate
lymphocytes), creating a well-established immune environment to defense infectious and
relapsing disease. Implants are rapidly coated with extracellular matrix proteins and immune
protein components for the formation of a typical capsule. At the specific time point before
implantation, the locally utilized of IFN in intracavity breast is assumed to modify cellular
immune responses thus contributing to decreasing infection and tumor recurrence.
PURPOSE: This non-randomized phase I trial aims to explore dose range of IFNα-2a. Adverse
events are observed to assess drug safety and human tolerance index.
Phase:
Phase 1
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University