Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT04292769
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
Sponsor:
Li Yu
Organization:
Study Overview
Official Title:
Clinical Study of Descitabine Enhanced Infusion of Autologous DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1. Screening stage
2. Evaluation of disease
3. Grouping of patients
4. Infusion of cells
5. Surveillance of adverse effect
2. Evaluation of disease
3. Grouping of patients
4. Infusion of cells
5. Surveillance of adverse effect
Detailed Description:
1. Screening stage：All patients must be confirmed by pathology priorily and reachead remission after surgery or chemo- or radiotherapy. All criteria patients must sign informed consent in advance.
2. Evaluation of disease: Systematically assessment of tumor burdern and Physical fitness of all patients.
3. Cell preparation：At least one month after the end of the last chemotherapy, 100ml of peripheral blood was collected, and PBMCs were separated and extracted in the tens of thousands and local hundreds of clean laboratories and DC-CIK cells were prepared.
4. Baseline assessment: Systematically assess various biochemical indicators. Those who do not meet the infusion criteria will withdraw from the study after being confirmed by researchers.
5. Study group: All subjects were randomly divided into test group and control group. The test group was treated with decitabine. The course of treatment was a total of 5 times.
6. Infusion：During cell culture and before transfusion, cells should be subjected to strict quality control tests such as bacteria, fungi, mycoplasma, endotoxin, cell activity, DC and T cell identification, etc. The transfusion can be approved only after the quality control is qualified.
7. Adverse reaction monitoring: DC-CIK infusion was used to closely observe changes in subjects' blood pressure, body temperature, blood routine, blood biochemistry, electrolytes, coagulation, cytokines and organ functions.
8. After the trial is completed, the patient's survival information will be followed up every 3 months by telephone or by visiting the test center.
2. Evaluation of disease: Systematically assessment of tumor burdern and Physical fitness of all patients.
3. Cell preparation：At least one month after the end of the last chemotherapy, 100ml of peripheral blood was collected, and PBMCs were separated and extracted in the tens of thousands and local hundreds of clean laboratories and DC-CIK cells were prepared.
4. Baseline assessment: Systematically assess various biochemical indicators. Those who do not meet the infusion criteria will withdraw from the study after being confirmed by researchers.
5. Study group: All subjects were randomly divided into test group and control group. The test group was treated with decitabine. The course of treatment was a total of 5 times.
6. Infusion：During cell culture and before transfusion, cells should be subjected to strict quality control tests such as bacteria, fungi, mycoplasma, endotoxin, cell activity, DC and T cell identification, etc. The transfusion can be approved only after the quality control is qualified.
7. Adverse reaction monitoring: DC-CIK infusion was used to closely observe changes in subjects' blood pressure, body temperature, blood routine, blood biochemistry, electrolytes, coagulation, cytokines and organ functions.
8. After the trial is completed, the patient's survival information will be followed up every 3 months by telephone or by visiting the test center.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: