Liver Transplantation Versus Conventional Medical Therapy for Low-Grade GEP-NET With Liver Metastases

Other illness

• Uncontrolled extrahepatic metastases or progressive disease despite adequate systemic therapy at enrollment.
• For candidates considering transplantation: serious comorbidities precluding major surgery, including uncontrolled cardiopulmonary disease, active infection, decompensated cirrhosis with severe portal hypertension, or other contraindications to transplantation and immunosuppression.
• Other active malignancy within the past 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).

Other

• Poorly differentiated neuroendocrine carcinoma (G3, Ki-67 above threshold) or mixed neuroendocrine/non-neuroendocrine neoplasm (MiNEN).
• Pregnancy or lactation.
• Inability or unwillingness to comply with protocol follow-up.
• Participation in another interventional clinical trial with potential interference with endpoints.

• Age 18-70 years at enrollment.
• Histologically confirmed, well-differentiated (G1 or G2) gastroenteropancreatic neuroendocrine tumor (pancreatic or midgut/hindgut primary).
• Unresectable, liver-dominant metastatic disease (multifocal/bilobar involvement not amenable to curative resection or ablation).
• Ki-67 proliferation index ≤ 10% at the most recent biopsy, with stable disease for at least 6 months on standard therapy.
• Primary tumor resected, or resectable/planned for resection as part of the treatment strategy.
• No uncontrolled extrahepatic metastatic disease.
• ECOG performance status 0-1.
• Treatment group assigned by patient/family preference after balanced multidisciplinary counseling; both options (transplantation vs conventional therapy) medically feasible and discussed.
• Written informed consent.