EUCTR2014-001402-18-ES进行中（未招募）1 期
CD133 + CELL INFUSION IN PATIENTS WITH COLORECTAL LIVER ORIGIN METASTASES GOING TO BE SUBMITTED TO A MAJOR LIVER RESECTION - CIRCO
ALEJANDRA GARCIA BOTELLA0 个研究点目标入组 4 人开始时间: 2014年10月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and ? 80 years old
- •2. Quality of Life Scale ECOG (Eastern Cooperative Oncology Group) ?2
- •3. Potential childbearing women must follow contraception methods recomended by Clinical Trial Facilitation Group (CTFG) .
- •4. patients with liver metastases from colorectal carcinoma, which have insufficient liver remnant to make a major hepatectomy. This volume is calculated by imaging with multidetector CT of 64 channels.
- •- patients who received preoperative chemotherapy and estimated residual liver volume <40%.
- •- Patients with preserved liver function who have not received chemotherapy and calculated residual volume <30%
- •5. Signing the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy or breastfeeding
- •2. Any condition that, according to the researchers, involving subjecting the patient to an unjustifiable risk.
- •3. Severe comorbidities: ASA ? 4.
- •4. Changes in the blood count and morphological alterations, hematologist accounted for prior to the administration of G-CSF.
- •5. Liver function: Child ? B7, INR ? 2 in anticoagulated patients, in patients anticoagulated values prior to the surgery reversed.
- •6. Participation in other research studies in the last 12 months.
- •7. Patients on chemotherapy, can not be administered G-CSF until they have not spent 48 hours after the last dose of chemotherapy. Patients who received Avastin must wait 30 days from the last administration.
- •8. Aspects that prevent the patient cannot be part of the study such as understanding the rules thereof, follow the instructions to be given, or other aspects deemed appropriate.
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