NCT04556214招募中不适用
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA)
- •First time iCCA or liver only recurrence after previous liver resection for iCCA
- •Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
- •No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging
- •No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan
- •Patient must be accepted for transplantation before progressive disease on chemotherapy.
- •Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation
- •No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit
- •At least 18 years of age
- •Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up
- •Received at least 6 months of chemotherapy or locoregional therapy
排除标准
- •Major vascular involvement of the tumor
- •Perforation of the visceral peritoneum
- •Weight loss >15% the last 6 months
- •Patient BMI > 30
- •Other malignancies, except curatively treated more than 5 years ago without relapse
- •Known history of human immunodeficiency virus (HIV) infection
- •Prior history of solid organ or bone marrow transplantation
- •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Known hypersensitivity to rapamycin
- •Prior extrahepatic metastatic disease
- •Women who are pregnant or breast feeding
- •Any reason why, in the opinion of the investigator, the patient should not participate
结局指标
主要结局
Overall Survival (OS)
时间窗: From screening and until 36 months after inclusion
OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome
次要结局
- Disease free survival(After liver transplantation and up 10 years after liver transplantation)
- Time to decrease in physical function and global health score(Up to 10 years after liver transplantation)
- Overall Survival from time of relapse(From time of relapse and until 36 months after inclusion)
- Number of Participants Developing other Malignancies(Up to 10 years after liver transplantation)
- Start of new treatment/Change of strategy(Immediately after liver transplatation to start of new treatment)
- Liver transplant Complication(Up to 90 days after liver transplantation)
- Survival in relation to biological markers(After Liver Transplant until 10 years after liver transplantation)
研究者
Magnus Smedman, MD
Consultant, gastrointestinal oncology
Oslo University Hospital
研究点 (2)
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