Clinical trial · Observational
The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients
The Intention-to-treat Effect of Bridging Therapies in the Setting of Milan-in Patients Waiting for Liver Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the usefulness of loco-regional therapies (LRT) in the context of liver transplantation (LT) is still debated. The inconsistent literature data are the result of initial selection biases among treated and untreated patients. In order to overcome these shortcomings, an inverse probability of treatment weighting (IPTW) analysis was done in a large patient cohort. After using a competing-risk analysis, the primary end-point of the study aims at identifying the risk factors of HCC-specific LT failure, defined as pre-LT tumour-related drop-out or post-LT recurrence.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Transplant; Failure, Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bridging followed by transplant | Procedure | — | UNRESOLVED |
| Direct liver transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Direct liver transplant
- description
- All the cases listed for liver transplantation and then transplanted/dropped-out without undergoing any neo-adjuvant loco-regional treatment
- interventionNames
- Procedure: Direct liver transplant
- label
- Bridging followed by transplant
- description
- All the cases listed for liver transplantation and then transplanted/dropped-out after undergoing at least one neo-adjuvant loco-regional treatment
- interventionNames
- Procedure: Bridging followed by transplant
Primary outcomes (1)
- measure
- Tumour-specific liver transplant failure rate
- timeFrame
- up to 5 years from first referral
- description
- Any case of tumor-related drop-out during the waiting list period or post-transplant recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * adults (≥18-year old) listed for liver transplant with a morphologic and/or histologic confirmed hepatocellular cancer Exclusion Criteria: * Milan Criteria-out status at first referral * transplantation or de-listing before January 1, 2001 * other means of loco-regional treatments such as partial hepatectomy, trans-arterial radio-embolization or external radiotherapy * misdiagnosed mixed hepatocellular-cholangiocellular cancer or cholangiocellular cancer
References
Publications (1)
- DERIVEDLai Q, Vitale A, Iesari S, Finkenstedt A, Mennini G, Onali S, Hoppe-Lotichius M, Manzia TM, Nicolini D, Avolio AW, Mrzljak A, Kocman B, Agnes S, Vivarelli M, Tisone G, Otto G, Tsochatzis E, Rossi M, Viveiros A, Ciccarelli O, Cillo U, Lerut J; European Hepatocellular Cancer Liver Transplant Study Group. The Intention-to-Treat Effect of Bridging Treatments in the Setting of Milan Criteria-In Patients Waiting for Liver Transplantation. Liver Transpl. 2019 Jul;25(7):1023-1033. doi: 10.1002/lt.25492. PMID 31087772