NCT04616495招募中不适用
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- five year overall survival (OS)
研究概览
简要总结
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •≥ 18 and ≤ years
- •Good performance status, ECOG 0 or 1
- •Resected adenocarcinoma in colon or rectum (R0 resection)
- •Unresectable liver metastases
- •No extrahepatic disease
- •Normal blood tests
- •Response to ≤ 2 lines of chemotherapy (RECIST criteria)
- •≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
- •Signed informed consent
排除标准
- •Body mass index ≥ 30
- •Positive HIV or HCV
- •Pregnancy at the time of inclusion
- •BRAF mutated status
- •Deterioration of general condition (10% weight loss in the prior 6 months)
- •Other malignancy with disease free survival < 5 years
- •Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
- •Palliative resection of primary colorectal adenocarcinoma
- •Liver metastases size > 5 cm (in the last imaging technique)
- •CEA > 80 ng/ml (at time of enrolment in waiting list)
- •No neoadjuvant chemotherapy treatment
- •General contraindication to liver transplantation
结局指标
主要结局
five year overall survival (OS)
时间窗: 5 years
次要结局
- Quality of life using EORTC questionnaires: QLQ-C30(5 years)
- three year disease free survival (DFS)(3 years)
- five year disease free survival (DFS)(5 years)
- one year disease free survival (DFS)(1 year)
研究者
Eva M. Montalvá
Hepatobiliarypancreatic and Transplant Surgeon
Hospital Universitario La Fe
研究点 (1)
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