Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors

Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Pharmacotherapy, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.

The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases

Inclusion Criteria:

• Diagnosis of NET of gastroenteropancreatic (GEP), pulmonary or unknown primary site origin
• Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit)
• Hepatic involvement ≤50% volume of the organ
• Radiological evidence of hepatic lesions (contemporaneous progression or appearance of extrahepatic lesions are allowed if not critical sites) that require change or initiation of systemic pharmacotherapy
• Patients undergoing , previously treated , or never treated with systemic medical therapy are eligible
• Patients with or without carcinoid syndrome are eligible
• Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification)
• Ki67 ≤ 20% (G1-G2)
• Life expectancy > 6 months
• Age ≥ 18 and < 80 years

Exclusion Criteria:

• Previous loco-regional post-surgical treatment
• Poorly differentiated histology
• Severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to be detailed), renal failure (creatinine > 2.0 mg/dl) and heart failure (NYHA 3-4 or unstable ischemic heart disease), contraindicating the interventional procedure or influencing the general prognosis (Investigator to provide details of exclusion)
• Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
• Patients with only extra-hepatic lesions