Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- Survival
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18 years
- •With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
- •Without general contraindication to LT
- •Written informed consent.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Intra-arterial administration of DC BeadsR (Other)
Control
Usual care
结局指标
主要结局
Survival
时间窗: 3 years
Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
次要结局
- Allograft survival(3 years)
- Time to dropout(3 years)
- TACE-induced complications (local and general)(3 years)
- Doxorubicin-induced complications(3 years)
- Dropout rate(3 years)
- Post-transplantation survival rate(3 years)
- Contrast agent - induced complications(3 years)
- Recurrence rate(3 years)
- Efficacy of TACE(3 years)