Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty enrollment, no patients received treatment
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| approved pharmacologic therapy | Drug | — | UNRESOLVED |
| TAE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pharmacologic therapy
- description
- Patients in this arm receive systemic pharmacologic therapy alone
- interventionNames
- Drug: approved pharmacologic therapy
- type
- EXPERIMENTAL
- label
- TAE and pharmacologic therapy
- description
- Patients in this arm receive systemic pharmacologic therapy and TAE
- interventionNames
- Drug: approved pharmacologic therapy
- Procedure: TAE
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available