Liver Transplantation Clinical Trial
— AFP-UTSOfficial title:
Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC) With Pre-transplant Radiology Assessment and Alpha-fetoprotein (α-fp)
Verified date | September 2017 |
Source | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 1018 |
Est. completion date | December 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 a-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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cancer specific survival | 5 years | ||
Secondary | Overall Survival | 5 years | ||
Secondary | Recurrence Free Survival | 5 years |
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