NCT04870879招募中不适用
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
Azienda Ospedaliera di Padova1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Weight loss >10% the last 6 months
- •Patient BMI > 30
- •Participation refusal
- •General contraindication to LT
- •Prior extra hepatic metastatic disease or primary tumor local relapse.
- •Other malignancies in the previous 5 years
- •Pregnancy or breast feeding
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究组 & 干预措施
Study arm
Experimental
Liver transplant
干预措施: Liver Transplant (Procedure)
Parallel arm
Other
Chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 years
次要结局
- Progression free survival(3 and 5 years)
- Proportion of drop out(within liver transplant)
- Complication rate(90 days after liver transplant)
研究者
Prof. Umberto Cillo
Prof
Azienda Ospedaliera di Padova
研究点 (1)
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