此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma (CATCH)

2019年4月10日 更新者:Rennes University Hospital

Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study

The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.

研究概览

详细说明

  • Multicentre, prospective, randomized, 2 parallel group study
  • Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria (size, number of nodules). Clinical and biological status will be updated every 3 month.
  • Pre-transplant treatment:

TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be injected as selectively as possible. Then, an embolic agent will be used to assure stop of flow. The first injection will be performed within 10 days following enlisting and repeated every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response. Clinical/biological follow-up will be done once a month.

Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3 month.

This prospective, multicentric, and randomized study may allow investigators to show that TACE with DC-BeadsR can significantly increase intention to treat survival of patients transplanted for HCC. We also expect that this result will be associated with less recurrence of the cancer after transplantation.

Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable rate of complication related to the procedure.

  • Pathologic examination: In all patients in whom LT will be performed, the diagnosis of hepatocellular carcinoma will be confirmed by a histological examination of the explanted liver.
  • Dropout criteria: Patients with progression but still meeting the transplant criteria will be maintained in their respective group. Patients with progression over the transplant criteria will be excluded from the waiting list and censored.

研究类型

介入性

注册 (实际的)

7

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Créteil、法国、94010
        • Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris
      • Grenoble、法国、38000
        • Hôpital Michalon, CHU de Grenoble
      • Lille、法国、59000
        • Hôpital Claude Huriez, CHU de Lille
      • Lyon、法国、69000
        • Hôpital de la Croix Rousse, HCL, Lyon
      • Paris、法国、75000
        • Hôpital Saint-Antoine / APHP
      • Rennes、法国、35033
        • Hopital Pontchaillou
      • Tours、法国、37000
        • Hôpital Trousseau, CHU de Tours

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients >18 years
  • With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
  • Without general contraindication to LT
  • Written informed consent.

Exclusion Criteria:

  • Patients that already had TACE
  • Or other local treatment for HCC
  • Or neoadjuvant systemic chemotherapy
  • Or planned living donor
  • Or non arterialized lesion(s)
  • Or Contraindication to DC-BeadsR
  • Or allergy to contrast agents
  • Or contraindication to Doxorubicin.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
日常护理
实验性的:Intra-arterial administration of DC BeadsR
Intra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium. The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Survival
大体时间:3 years
Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
3 years

次要结果测量

结果测量
措施说明
大体时间
复发率
大体时间:3年
3年
Dropout rate
大体时间:3 years
Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)
3 years
Post-transplantation survival rate
大体时间:3 years
3 years
Allograft survival
大体时间:3 years
3 years
Time to dropout
大体时间:3 years
3 years
TACE-induced complications (local and general)
大体时间:3 years
3 years
Contrast agent - induced complications
大体时间:3 years
3 years
Doxorubicin-induced complications
大体时间:3 years
3 years
Efficacy of TACE
大体时间:3 years
Efficacy of TACE (morphological response to TACE: captation rate of Lipiodol and morphological response (RECIST guidelines), as well as histological criteria: percentage of necrosis on pathological examination)
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Philippe COMPAGNON, MD、Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est
  • 首席研究员:Karim BOUDJEMA, MD PhD、Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1
  • 学习椅:Bruno Laviolle, MD, PhD、Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2014年5月28日

研究完成 (实际的)

2016年2月16日

研究注册日期

首次提交

2012年8月28日

首先提交符合 QC 标准的

2012年8月28日

首次发布 (估计)

2012年8月30日

研究记录更新

最后更新发布 (实际的)

2019年4月12日

上次提交的符合 QC 标准的更新

2019年4月10日

最后验证

2018年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅