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Spots Global Cancer Trial Database for Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

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Trial Identification

Brief Title: Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

Official Title: Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

Study ID: NCT04522557

Interventions

IFNα-2a

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Shicheng Su, Guangzhou, Guangdong, China

Contact Details

Name: Shicheng Su, M.D.,Ph.D.

Affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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