ArTisaN trial protocol: a single Centre, open-label, phase II trial of the safety and efficacy of TheraSphere selective internal radiation therapy (SIRT) in the treatment of inoperable metastatic (liver) neuroendocrine neoplasia (NENs)

Rohini Sharma, Susanna Slater, Joanne Evans, Maria Martinez, Caroline Ward, Hooshang Izadi, Florian Wernig, Rob Thomas, Rohini Sharma, Susanna Slater, Joanne Evans, Maria Martinez, Caroline Ward, Hooshang Izadi, Florian Wernig, Rob Thomas

Abstract

Background: Neuroendocrine neoplasias (NENs) are a rare type of malignancy that arise from the cells of the neuroendocrine system. Most patients present with advanced, unresectable disease, typically with metastases to the liver. The presence of liver metastases dictates prognosis and there has been a number of studies investigating therapies that reduce the burden of liver disease. Selective Internal Radiation Therapy (SIRT) allows the delivery of targeted high dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Here, we describe the design and rationale of ArtTisaN, a phase II study to assess efficacy and tolerability of SIRT using TheraSpheres for the management of liver metastases secondary to NENs.

Methods: Twenty-four eligible participants will be recruited to receive SIRT with TheraSpheres. The primary objective is to determine the objective response rate to treatment, defined as the rate of best overall response in the treated liver volume. In addition, total hepatic response and overall response will be assessed according to RECIST 1.1. The second co-primary objective is to determine the incidence of adverse and serious adverse device events. The secondary objectives are progression free survival, overall survival and quality of life. Additional exploratory objectives include investigation of circulating biomarkers of response and identification of a radiomic signature of response.

Discussion: This trial will provide prospective evidence on the efficacy of SIRT using TheraSpheres for the management of liver metastases.

Trial registration: NCT04362436 .

Keywords: Neuroendocrine neoplasia; Quality of life; Response; Safety; Selective internal radiotherapy.

Conflict of interest statement

RS received lecture fees from Bayer Healthcare, SIRTEX, Roche; consulting fees from SIRTEX, EISAI, Roche; received research funding (to institution) from Incyte, Boston Scientific, AAA and Astex pharmaceuticals.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trial Schema and TheraSphere Treatment Schedule

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