CapTemY90 for Grade 2/3 NET Liver Metastases

Inclusion Criteria:

• Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiatedneuroendocrine tumor with unresectable liver metastases (primary tumor or otherextrahepatic disease may be present)

• Patients with at least one measurable liver metastases, with size > 1cm (RECISTcriteria)

• Patients with liver dominant disease defined as ≥50% tumor body burden confined tothe liver

• Liver tumor burden does not exceed 50% of the liver volume

• Patent main portal vein

• At least 4 weeks since last administration of last chemotherapy and /or radiotherapy

• Age >18 years.

• Life expectancy of greater than 6 months.

• ECOG performance status 0-2.

• Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5times ULN, albumin ≥2.5g/dl.

• Patients must have adequate organ and marrow function as defined below:

• platelets >100,000/mcL (may be corrected by transfusion)

• serum creatinine < 2.0 mg/dl

• INR <1.6, (may be corrected by transfusion)

• Ability to understand and the willingness to sign a written informed consentdocument.

• Women of child bearing potential and fertile men are required to use effectivecontraception (negative urine or serum βHCG for women of child-bearing age)

Exclusion Criteria:

• Contraindications to capecitibine or temozolomide

• Contraindicated for both contrast-enhanced MRI and CT

• Patients previously treated with transarterial embolization (with or withoutchemotherapy) or with radioembolization (Y-90 microspheres)

• Contraindication for radioembolization procedures:

• excessive hepatopulmonary shunt as determined by the investigator

• inability to deliver Y90 microspheres without risk of non-target embolization ofextra-hepatic structures

• Subjects consenting to the trial who fail their simulation angiography will beremoved from the study and replaced.

• Patients may not be receiving any other investigational agents.

• Absolute contraindication to intravenous iodinated contrast (Hx of significantprevious contrast reaction, not mitigated by appropriate pre-medication).

• Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenalpapilla;

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• Pregnant and lactating women are ineligible