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

Phase 2

Completed

• Conditions: lever- en galwegneoplasmata malgine en niet-gespecificeerd; liver metastases of neuroendocrine tumor; 10019815; 10014713

• Registration Number: NL-OMON45045
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Tumour response at 3 months </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Safety and toxicity profile of 166Ho-RE as adjuvant treatment after<br /><br>177Lu-dotatate<br /><br>* Changes in tumour markers<br /><br>* Quality of Life (QoL)<br /><br>* Biodistribution / Dosimetry</p><br>