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: 2022年3月21日

试验速览

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•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

•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.

发起方

ALEJANDRA GARCIA BOTELLA