Adjuvant hepatic Holmium-166-radioembolization in patients with unresectable liver metastases of neuroendocrine origin, who have been treated with Lutetium-177-dotatate; a single center, interventional, non-randomized, non-comparative, open label, phase II study - HEPAR PLUS-trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•* Patients must have given written informed consent (Appendix IV and V).
•* Female or male aged 18 years and over.
•* Confirmed histological diagnosis NET, including bronchial carcinoids, and metastatic malignancy with liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
•* Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 20 weeks of 166Ho-RE.
•* Life expectancy of 12 weeks or longer.
•* World Health Organisation (WHO) Performance status 0-2 (see Appendix VI).
•* Liver disease with three or more measurable liver lesions according to the RECIST 1.1 criteria.
•* Negative pregnancy test for women of childbearing potential.

•* Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
•* Radiation therapy within the last 4 weeks before the start of study therapy.
•* The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
•* Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
•* Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
•* Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
•* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
•* Leukocytes < 2.0 10EXP9/l and/or platelet count < 50 10EXP9/l.
•* Patients who are declared incompetent

发起方

niversitair Medisch Centrum Utrecht