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临床试验/NCT02898415
NCT02898415已完成不适用

Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC) With Pre-transplant Radiology Assessment and Alpha-fetoprotein (α-fp)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano0 个研究点目标入组 1,018 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,018
主要终点
Cancer specific survival

研究概览

简要总结

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

详细描述

Rationale: 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.

Over time, various attempts have also been made to correlate postoperative pathologic findings of HCC to preoperative clinical staging in order to anticipate decision-making. Should a reliable conversion algorithm correlating pre-operative staging with post-transplant prognosis be available a selection of LT candidates based on routine radiologic HCC findings would optimise survival patient survival and organ resource allocation.

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 variables.

Another important issue to be considered when dealing with LT for HCC is the striking progress in treating chronic viral infections (HCV and HBV) that has been achieved over the last few years. Due to the possibility of treating recurrence of viral infections in the transplanted liver, these conditions do not significantly affect mortality following LT as they did in the past.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 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).

排除标准

  • < 18-year-old patients
  • incidentally discovered HCC
  • macroscopic invasion of vascular structures
  • extra-hepatic spread

结局指标

主要结局

Cancer specific survival

时间窗: 5 years

次要结局

  • Recurrence Free Survival(5 years)
  • Overall Survival(5 years)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincenzo Mazzaferro

MD PhD

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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