Clinical trial · Observational
Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC)
Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC) With Pre-transplant Radiology Assessment and Alpha-fetoprotein (α-fp)
- 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)
Liver transplantation (LT) is one of the curative treatment options for patients with HCC associated to chronic liver disease (cirrhosis). All current international guidelines recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to select patients affected by HCC for LT was originally proposed with the Milan criteria. These criteria were based on pathologic assessment of number and size of the HCC nodules on the explanted liver. Subsequently, many authors proposed the expansion of such restrictive criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different combinations of morphologic parameters, have been defined on the pathologic staging of the tumor made on the removed liver, namely after LT, once decision on treatment and treatment itself could not be changed Although post-LT pathology / pre-LT radiology correlation have improved over time, significant biases still affect clinical assessment of HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust evidence indicates that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical response to bridge therapies) have to be added when evaluating pre-operative variable Although many studies have been conducted, prognostic calculators of cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet available. Such models should be able to provide survival estimates based on pre-treatment oncologic variables. The main goal of the study is the definition of a cancer-specific prognostic model based on pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of patients who underwent LT for HCC. Considering the competitive risk of cancer-specific mortality and death due to other causes, the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the base of pathologic staging
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alphafetoprotein | — | UNRESOLVED | — |
| Cancer Recurrence | — | UNRESOLVED | — |
| Competing Risk | — | UNRESOLVED | — |
| HCC | — | UNRESOLVED | — |
| Liver Transplantation | — | UNRESOLVED | — |
| Mortality | — | UNRESOLVED | — |
| Selection Criteria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Training set
- description
- Consecutive patients who underwent liver transplantation for HCC at Italian transplant centers
- interventionNames
- Procedure: Liver transplantation
Primary outcomes (1)
- measure
- Cancer specific survival
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 5 years
- measure
- Recurrence Free Survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18-year-old patients with a definite pre-operative diagnosis of HCC (either radiologic or pathologic) who underwent their first LT in Italian tertiary centres for liver cancer, over a period of at least 10 years after 2000; * Available clinical parameters of HCC (morphology and α-Fetoprotein levels) both in the evaluation process and during their stay within the waiting list; * Evaluable clinical response to either medical or interventional anti-cancer treatments delivered prior to LT, by means of RECIST criteria (1.1 or mRECIST/EASL); * Fully described co-morbidities; * Completed oncologic follow-up (disease recurrence and/or cancer-specific death) and hepatologic/transplant follow-up (liver disease recurrence or onset of non-oncologic disease and/or death from any cause). Exclusion Criteria: * \< 18-year-old patients * incidentally discovered HCC * macroscopic invasion of vascular structures * extra-hepatic spread
References
Publications (1)
- DERIVEDMazzaferro V, Sposito C, Zhou J, Pinna AD, De Carlis L, Fan J, Cescon M, Di Sandro S, Yi-Feng H, Lauterio A, Bongini M, Cucchetti A. Metroticket 2.0 Model for Analysis of Competing Risks of Death After Liver Transplantation for Hepatocellular Carcinoma. Gastroenterology. 2018 Jan;154(1):128-139. doi: 10.1053/j.gastro.2017.09.025. Epub 2017 Oct 5. PMID 28989060