Advanced malignancies
Conditions
Interventions
Case series:neoantigen peptides caccine combined with neoantigen reactive T cells
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients volunteer to join in the trial and sign the informed consents; 2. Adult patients aged 18 to 75 years oldno gender limitation; 3. Histologic or cytologic confirmation of advanced refractory tumors with no available curative treatment options(can not be resected or have already metastasized); with at least two lesions and at least one measurable lesion; 4. TNM stage II-IV (AJCC 7th); 5. Expected survival time three months or more; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; 7. Hematology Index including: neutrophile granulocyte greater than 1.5×10^9/L; hemoglobin greater than 10g/dL; platelet greater than 100×10^9/L; 8. Biochemical index including: Serum bilirubin not greater than 1.5× upper limit of reference range (ULN); ALT or AST not greater than 2.5× ULN; creatinine clearance no less than 60ml/min; 9. Negative pregnancy test for women of childbearing potential, and patients must be willing to practice birth control during the research.
Exclusion criteria
Exclusion criteria: 1. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group; 2. History of bone marrow transplantation, stem cell transplantation or organ transplantationpatients with definite hemorrhage of digestive tract or hemorrhagic tendency; 3. Any form of primary immunodeficiency or history of autoimmune disease; 4. Prior treatment with other immunotherapy within 1 month; 5. May be allergic to immunotherapy; 6. Drug abuse, clinical or psychological or social factors which will influence the informed consent or the study implementation; 7. Women who are pregnant or breast feeding; 8. Patients who are participating in or have participated in other clinical trials within a month; 9. Any other uncertain factors that will influence the safety or compliance of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;safety;immune indexes; | — |
Countries
China
Contacts
Public ContactZeng Yongyi
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed