Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To develop a registry of liver transplantation in patients with liver limited metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital (WCMC / NYPH)
研究概览
简要总结
This is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. The registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.
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
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
- •No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
- •Age 18-65 years old
- •Good performance status with ECOG 0-1
- •Stability or regression of liver metastasis for at least 6 months
- •Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
- •Minimum of 6 months chemotherapy
- •CEA < 200 ug/L 3 months prior to transplant
- •Adequate organ and marrow function with Hb > 10 g/dL, ANC > 1000/uL, platelets > 100,000/uL, bilirubin < 2x ULN, AST/ALT < 5x ULN, Creatinine < 1.25 x ULN, Albumin above LLN
排除标准
- •Evidence of extrahepatic disease or local recurrence
- •Previous resection of lung metastases
- •MSI-H/dMMR or BRAF mutation
- •Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
结局指标
主要结局
To develop a registry of liver transplantation in patients with liver limited metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital (WCMC / NYPH)
时间窗: 25 years
次要结局
- To determine overall survival (OS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital(25 years)
- To determine disease-free survival (DFS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital(25 years)