TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

NCT04362436 | Completed Phase 2 DMC

• 1 other identifier: 231087
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study for patients with inoperable metastatic neuroendocrine liver deposits to see whether treatment with Selective Internal Radiation Therapy (TheraSpheres) could lead to improved treatment response rates with acceptable toxicity (minimal serious adverse events reported). This research will also look at the progression free survival and quality of life of the patients who decide to join the study.

Conditions

Neuroendocrine Tumors; Liver Metastases

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Record incidence of adverse events overall and by severity, as well as serious adverse events using the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) for Adverse Events, version 4.03 (CTCAE V4.03)

  Throughout study completion, up to 1 year

• Define objective response rate (ORR)

  This is the best overall response (CR+PR) determined by RECIST 1.1

  Throughout study completion, up to 1 year

Secondary Outcomes (4)

• Progression free survival

  Throughout study completion, up to 1 year

• Overall survival

  Throughout study completion, up to 1 year

• Quality of life

  Throughout study completion, up to 1 year

• Quality of life 2

  Throughout study completion, up to 1 year

Other Outcomes (2)

• Radiomics

  Throughout study completion, up to 1 year

• Measurement of ctDNA, as a biomarker, in response to TheraSpheres

  Throughout study completion, up to 1 year

Study Arms (1)

TheraSpheres Selective Internal Radiation Therapy (SIRT)

EXPERIMENTAL

Radiation therapy

Radiation: TheraSpheres Selective Internal Radiation Therapy (SIRT)

Interventions

TheraSpheres Selective Internal Radiation Therapy (SIRT) RADIATION

Single-photon emission computed tomography (SPECT) imaging will assess 99mTc-MAA (MAA being macro aggregated albumin) deposition in the tumour bed to estimate the dose of radiation to tumour and healthy tissue, before administration of TheraSpheres to eligible patients

TheraSpheres Selective Internal Radiation Therapy (SIRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be discussed at a specialist hepatobiliary multi-disciplinary team meeting (MDT) and meet the following criteria:
• Histologically confirmed neuroendocrine tumour, with documented grade.
• \>18 years of age
• Patients may be on SSAs concurrently.Patients must have had at least one previous line of therapy
• Unresectable liver only or liver predominant metastases (typically involving \>25% but \<60% of the liver, and technically inoperable, or unfeasible secondary to medical comorbidity)
• Have measurable disease by RECIST 1.1 criteria
• Life expectancy of \>12 weeks
• Eastern Cooperative Oncology Group (ECOG) / World Health Organisation (WHO) Performance Status of 0-1
• Adequate liver function (bilirubin less than 34 umol/L in the absence of a reversible cause)
• Blood work: patients must have
• Platelet count of \> or = to 50x10\^9/L
• Hb of \> or = to 8.5g/dL
• Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) \< 5 x Upper limit of normal (ULN)
• Serum creatinine \< 1.5 x ULN
• Internal Normalised Ration (INR) \< 2.0

You may not qualify if:

• Clinically apparent ascites or other signs of hepatic failure on physical examination
• Severe uncontrollable coagulopathy
• No safe vascular access to the liver, as determined by triple phase CT
• Potential for excess radiation exposure (\>30Gy) to the lungs, as determined by pretreatment 99mTc-MAA lung shunt (\>20% shunt)
• Shunting to the GI tract that cannot be corrected by embolization, as demonstrated by hepatic angiogram
• Previous Transarterial chemoembolization (TACE) or SIRT
• Multiple biliary stents, or ongoing cholangitis, or any intervention for, or compromise of, the Ampulla of Vater
• Previous external bean radiotherapy to the liver
• Systemic anti-cancer therapy within the last 4 weeks (excluding 1st line therapy with SSA)
• Treatment with Vascular endothelial growth factor (VEGF) inhibitors within 3 months prior to therapy
• Previous or concurrent cancer, other than Basal Cell Carcinoma, unless treated curatively 5 or more years prior to entry
• Tumour involvement of \>60% of the liver
• Oesophageal bleeding during the last 3 months
• Any history of hepatic encephalopathy
• Transjugular intrahepatic portosystemic shunt (TIPS)

Sponsors & Collaborators

• Imperial College London: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (1)

Imperial College NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• Sharma R, Slater S, Evans J, Martinez M, Ward C, Izadi H, Wernig F, Thomas R. 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). BMC Cancer. 2022 Jul 20;22(1):800. doi: 10.1186/s12885-022-09859-9.

  PMID: 35858849 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Rohini Sharma, MD

  Senior Lecturer Medical Oncology and Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 27, 2020
• Study Start: February 5, 2019
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

GB (1)