NCT02215889招募中1 期
A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.
研究概览
简要总结
The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified adenocarcinoma in colon/rectum.
- •Liver metastases, not amenable to liver resection
- •No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all<15mm.
- •No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all<15mm.
- •No local recurrence according to MR-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit
- •No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
- •Good performance status, ECOG 0 or
- •Satisfactory blood tests: Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, Creatinine <1.25 x upper normal level. Albumin above lower normal level.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
- •All patients should have received at least 8 weeks of chemotherapy.
排除标准
- •Weight loss >10% the last 6 months
- •Patient BMI > 30
- •Previous diagnosed bone or CNS metastatic disease.
- •Previous diagnosed cancer mammae or malignant melanoma.
- •Palliative resection of primary CRC tumor.
结局指标
主要结局
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.
时间窗: 4 weeks
次要结局
- Overall Survival(5 years)
研究者
Magnus Smedman, MD
M.D
Oslo University Hospital
研究点 (2)
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