The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.
20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1,3,5,11,17,23,35,47.
300 mg/m2 by vein before the first cell infusion.
safety endpoint
All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.
Time frame: one year
Overall Response Rate
Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.
Time frame: one year
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
Time frame: one year
Secondary safety endpoint
All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;
Time frame: one year
Six month DCR(CRR+PRR+SDR)
Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;
Time frame: 6 month
Duration of Response(DOR)
The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.
Time frame: one year
Progression-free survival(PFS)
The time from entering the trial till the subject has been diagnosed with progression of disease or died.
Time frame: one year
rate of 12-month survival
Percentage of cases with 12 months survival after initiation of treatment in all the subjects;
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Time frame: one year
Quality score of life improvement
Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.
Time frame: one year