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Enrolling by invitation Observational

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

NCT07913113 · tracked via the Priya Life Science China tracker
Sponsor
Chiyi Chen
Phase
Observational
Started
2019-01-01
Last updated
2026-11-03

Condition(s) studied

Neuroendocrine Tumors

Investigational drug(s) / intervention(s)

Liver Transplantation

Liver Transplantation: Deceased-donor or living-donor liver transplantation performed at Tianjin First Central Hospital on the basis of conventional medical therapy.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age 18-70 years at enrollment. 2. Histologically confirmed, well-differentiated (G1 or G2) gastroenteropancreatic neuroendocrine tumor (pancreatic or midgut/hindgut primary). 3. Unresectable, liver-dominant metastatic disease (multifocal/bilobar involvement not amenable to curative resection or ablation). 4. Ki-67 proliferation index ≤ 10% at the most recent biopsy, with stable disease for at least 6 months on standard therapy. 5. Primary tumor resected, or resectable/planned for resection as part of the treatment strategy. 6. No uncontrolled extrahepatic metastatic disease. 7. ECOG performance status 0-1. 8. Treatment group assigned by patient/family preference after balanced multidisciplinary counseling; both options (transplantation vs conventional therapy) medically feasible and discussed. 9. Written informed consent. Exclusion Criteria: 1. Poorly differentiated neuroendocrine carcinoma (G3, Ki-67 above threshold) or mixed neuroendocrine/non-neuroendocrine neoplasm (MiNEN). 2. Uncontrolled extrahepatic metastases or progressive disease despite adequate systemic therapy at enrollment. 3. 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. 4. Pregnancy or lactation. 5. Other active malignancy within the past 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ). 6. Inability or unwillingness to comply with protocol follow-up. 7. Participation in another interventional clinical trial with potential interference with endpoints.

Primary outcome measure(s)

  • 5-Year Overall Survival — Up to 5 years after enrollment
    Time from enrollment to death from any cause, assessed up to 5 years after enrollment. OS will be estimated by the Kaplan-Meier method and compared between groups using the log-rank test.

Trial sites (1)

FacilityCityRegionStatus
Tianjin Firsr Central Hospital Tianjin Tianjin Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07913113 on ClinicalTrials.gov ↗ ← All trials in China