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临床试验/NCT01549795
NCT01549795Unknown不适用

Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante

Azienda Ospedaliera di Padova2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
33
试验地点
2
主要终点
Time to recurrence after liver transplant

研究概览

简要总结

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.

Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.

New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years
  • Male or female
  • Diagnosis of Cholangiocarcinoma using:
  • PTBD biopsy or Brushing cytology
  • Ca 19-9>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
  • Non resectable tumour araising above the cystic duct
  • Absence of intra and extra hepatic metastasis
  • ECOG score(Eastern Cooperative Oncology Group) 0
  • ASA score (American Society of Anesthesiologists) ≤ 3
  • Ability to understand and willingness to sign the written informed consent form (ICF)

排除标准

  • Intrahepatic Cholangiocarcinoma
  • Non controlled infection
  • Previous radio or chemotherapy
  • Previsous bile duct resection or attempt to resection
  • Intra and/or extrahepatic metastasis
  • Preivious malignant neoplasm (within 5 years)
  • Execution of trans peritoneal biopsy
  • Tumour diameter more than 3 cm

结局指标

主要结局

Time to recurrence after liver transplant

时间窗: 24 months

Percentage of patients free of disease at 24 months post-transplant

时间窗: 24 months

次要结局

  • Progression disease free survival(24 months)
  • Overall 2 years survival after liver transplantation(24 months)
  • Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)(24 months)

研究者

发起方
Azienda Ospedaliera di Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Umberto Cillo

Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Azienda Ospedaliera di Padova

研究点 (2)

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