TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor (NCT03185429) | Clinical Trial Compass
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TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor
20 participantsStarted 2017-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Be ≥18 and ≤75,no gender based;
✓. Expression of HLA-A0201/1101/2402;
✓. Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
✓. Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
✓. Failure in conventional treatment， or though benefit from chemotherapy the patient can't tolerant subjectively;
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;
✓. Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;
✓. Serology：Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology：Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3)，lymphocyte count ≥ 800/mm(3)，Platelet count ≥ 100,000/mm(3)，Hemoglobin ≥ 9.0 g/dl Chemistry：Serum ALT/AST ≤ 2.5 times the upper limit of normal，Serum Creatinine ≤1.6 mg/dl，Total bilirubin \< 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin \< 3.0 mg/dl;
Exclusion criteria
✕. Is pregnant or breastfeeding,or expecting to conceive;
What they're measuring
1
safety endpoint
Timeframe: one year
2
Overall Response Rate
Timeframe: one year
3
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
✕. Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
✕. Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
✕. Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
✕. Have clinical symptoms of central nervous system metastases;
✕. Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;
✕. Have any active autoimmune disease ;
✕. Be in active infection or undergo an unknown cause fever\> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );