Status:
COMPLETED
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rise...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
- ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
- Patients with hepatic metastases of colorectal carcinoma and insufficient hepatic remnant function to perform a major hepatectomy. This volume would be calculated by Positron emission tomography-Computed tomography (PET-CT) images or 64-channel multidetector CT.
- In patients who have received preoperative chemotherapy, the estimate residual liver volume to be included in the study will be \<40%.
- Patients who have preserved liver function (Child ≤ B7 and International Normalized Ratio (INR) ≤ 2 in non-anticoagulated patients) and those who have not received chemotherapy, needs \< 30% of residual volume to be included in the study.
- Patients should have signed informed consent.
- Exclusion criteria:
- Pregnancy or lactation period.
- Any condition that the investigators consider an unjustifiable risk in the patient.
- Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
- Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
- Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
- Patients who have not received research drugs in the last 30 days or in the period of 5 elimination half-life.
- In patients on chemotherapy treatment, G-CSF can not be administered until 48 hours after the last administration of chemotherapy. Patients who have received Bevacizumab must wait 30 days since the last administration.
- In addition, all those aspects that prevent the patient from being part of the study, understand the rules, follow the instructions given, or other aspects.
Exclusion
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03803241
Start Date
May 31 2019
End Date
June 30 2021
Last Update
September 27 2021
Active Locations (2)
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1
Hospital Clinico San Carlos
Madrid, Spain, 28031
2
Alejandra Garcia Botella
Madrid, Spain, 28040