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临床试验/NCT05276037
NCT05276037招募中不适用

Extension of Liver Transplantation Opportunity to Patients Suffering From Milan-out, Up-to-7-in, Hepatocellular Carcinoma: a Prospective Belgian Study of the Value of Negative 18FDG PET/CT

University of Liege6 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
6
主要终点
Survival

研究概览

简要总结

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria.

The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian "Fondation contre le cancer" / "Stichting tegen Kanker".

详细描述

All adult patients (> 18 and < 80 years) suffering from HCC and discussed for potential deceased or living related LT during multidisciplinary oncologic meetings in the 6 Belgian LT centres will be consecutively included in the prospective database after signing an informed consent form. Date of inclusion will be the date of discussion at the first multidisciplinary oncological meeting. All patients who are not contra indicated for LT due to general medical conditions (as presented in the exclusion criteria) or due to HCC staging (evidence of extrahepatic extension or cancerous macroscopic invasion of a liver vein at imaging) will be included in the database. These patients will be either directly listed on the Eurotransplant waiting list if considered within the local LT criteria by the given centre, or potentially listed after successful down-staging or HCC recurrence after a first attempt of curative management (ex: resection, radiofrequency ablation (RFA), ....).

A prospective, secured, anonymized (GDPR compliant), web-based database will be constructed with the help of an experienced company.

For LT listing, diagnosis of HCC will be based on international recommendations and Eurotransplant rules, either on biopsy or on imaging (AFP >400 ng/mL and 1 positive result with hypervascularisation on CT and/or MRI), or AFP < 400ng/mL and 2 positive results with CT and MRI). Hepatic lesions of <1cm will not be considered for preoperative radiologic staging. All of the relevant liver images will be stored in a secured (GDPR compliant) web-based server and will be reviewed by a multicentre panel of expert radiologists in order to confirm the radiologic staging according to Milan and up-to-seven criteria.

Registration of HCC patients on the Eurotransplant waiting list will not be modified. Transplant candidates will be registered on the LT waiting list according to Eurotransplant and Be-LIAC allocation rules:

  • 1 HCC nodule > 2cm: labMELD score;
  • HCC within the Milan criteria: (1 HCC nodule ≤ 5 cm or 3 nodules ≤ 3cm) exceptional standard exception (SE) MELD points;
  • HCC outside the Milan criteria but successfully down-staged to inside Milan criteria: exceptional SE MELD points;
  • HCC outside Milan criteria, within up-to-7 criteria, PET negative (≤ 1.15): exceptional SE MELD points;
  • HCC outside Milan criteria, within up-to-7 criteria, PET positive (> 1.15) or outside up-to-7 criteria: labMELD score.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HepatoCellular Carcinoma
  • Liver transplant candidate after multidisciplinary disccuss

排除标准

  • Patients < 18y or > 80yr old
  • Patients considered contra-indicated (CI) for LT due to non-liver-related medical problems (age, other cancer, psychiatric disease, uncontrolled infection, no compliance, active alcohol abuse, cardiac CI, pulmonary CI, surgical CI, other medical CI);
  • Patients contra-indicated for LT due to the HCC: extra-hepatic metastases (M+), lymphatic involvement (N+), macro-vascular invasion.

结局指标

主要结局

Survival

时间窗: 1,2, 5, and 10 years after LT

Intention-to-treat (at LT waiting list registration) and post LT disease-free (DFS), recurrence-free (RFS) and overall survivals (OS)

次要结局

  • FDG PET-CT as a pronostic factor for HCC patients undergoing liver transplantation(1,2, 5, and 10 years after LT)
  • FDG PET-CT value in Milan-in patients(1,2, 5, and 10 years after LT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivier Detry MD PhD

Associate professor, Surgical head of the liver transplantation program

University of Liege

研究点 (6)

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