Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma (CATCH)
Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
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
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Créteil、法国、94010
- Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris
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Grenoble、法国、38000
- Hôpital Michalon, CHU de Grenoble
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Lille、法国、59000
- Hôpital Claude Huriez, CHU de Lille
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Lyon、法国、69000
- Hôpital de la Croix Rousse, HCL, Lyon
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Paris、法国、75000
- Hôpital Saint-Antoine / APHP
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Rennes、法国、35033
- Hopital Pontchaillou
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Tours、法国、37000
- Hôpital Trousseau, CHU de Tours
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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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
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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
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Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
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3 years
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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
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3年
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Dropout rate
大体时间:3 years
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Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)
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3 years
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Post-transplantation survival rate
大体时间:3 years
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3 years
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Allograft survival
大体时间:3 years
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3 years
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Time to dropout
大体时间:3 years
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3 years
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TACE-induced complications (local and general)
大体时间:3 years
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3 years
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Contrast agent - induced complications
大体时间:3 years
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3 years
|
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Doxorubicin-induced complications
大体时间:3 years
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3 years
|
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Efficacy of TACE
大体时间:3 years
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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
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合作者和调查者
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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