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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45045

Enrollment

Registered

2014-01-31

Start date

2014-10-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lever- en galwegneoplasmata malgine en niet-gespecificeerd liver metastases of neuroendocrine tumor

Interventions

166Ho-RE will be performed via a catheter during angiography

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 5 x ULN. * Leukocytes

Design outcomes

Primary

Measure	Time frame
* Tumour response at 3 months	—

Secondary

Measure	Time frame
* Safety and toxicity profile of 166Ho-RE as adjuvant treatment after 177Lu-dotatate * Changes in tumour markers * Quality of Life (QoL) * Biodistribution / Dosimetry	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)