Malignant Neoplasm Clinical Trial
Official title:
Clinical Study of Descitabine Enhanced Infusion of Autologous DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
1. Screening stage
2. Evaluation of disease
3. Grouping of patients
4. Infusion of cells
5. Surveillance of adverse effect
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.
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