Table 1 ArTisaN inclusion and exclusion criteria

1. Histologically confirmed neuroendocrine tumour, with documented grade.

2. > 18 years of age

3. Patients may be on SSAs concurrently.

4. Patients must have had at least one previous line of therapy

5. Unresectable liver only or liver predominant metastases (typically involving > 25% but < 60% of the liver, and technically inoperable, or unfeasible secondary to medical co-morbidity)

6. Have measurable disease by RECIST 1.1 criteria

7. Life expectancy of > 12 weeks

8. ECOG/WHO Performance Status of 0–1

9. Adequate liver function (bilirubin less than 34 umol/L in the absence of a reversible cause)

10. Blood work: patients must have

     °Platelet count of > or = to 50 × 10⁹/L

     °Hb of > 8.5 g/dL

     °ALT and AST < 5 x Upper limit of normal (ULN)

    °Serum creatinine < 1.5 x ULN

°INR < 2.0

11. Patients with portal vein thrombosis may be considered, as determined at MDT

1. Clinically apparent ascites or other signs of hepatic failure on physical examination

2. Severe uncontrollable coagulopathy

3. No safe vascular access to the liver, as determined by triple phase CT

4. Potential for excess radiation exposure (>30Gy) to the lungs, as determined by pre-treatment 99mTc-MAA lung shunt (> 20% shunt)

5. Shunting to the GI tract that cannot be corrected by embolization, as demonstrated by hepatic angiogram

6. Previous TACE or SIRT

7. Multiple biliary stents, or ongoing cholangitis, or any intervention for, or compromise of, the Ampulla of Vater

8. Previous external bean radiotherapy to the liver

9. Systemic anti-cancer therapy within the last 4 weeks (excluding SSA)

10. Treatment with VEGF inhibitors within 3 months prior to therapy

11. Previous or concurrent cancer, other than Basal Cell Carcinoma, unless treated curatively 5 or more years prior to entry

12. Tumour involvement of > 60% of the liver

13. Oesophageal bleeding during the last 3 months

14. Any history of hepatic encephalopathy

15. Transjugular intrahepatic portosystemic shunt (TIPS)

16. Must not be at risk of hepatic or renal failure

17. Contraindications against angiography

18. Pregnancy and breast feeding. Women of child-bearing potential must have a negative pregnancy test 14 days before treatment, and at the time of TheraSphere administration.

19. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.

20. Must not be participating in concurrent clinical trials evaluating treatment intervention(s).