Solid tumor
Conditions
Interventions
Case series:neoantigen peptides vaccine
Sponsors
Tianjin Beichen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. III or IV stage patients with with locally advanced or recurrent, metastatic solid tumors (diagnosed by pathology); 2. Adult patients aged 18 or more; 3. Expected survival three months or more; 4. Eastern Cooperative Oncology Group (ECOG) is 0 to 3; 5. Biopsy samples or pathology slice available, and more than one genetic mutation; 6. No previous immunotherapy including PD-1, anti-PD-L1 or anti-PD-L2 drugs or T cell receptor (such as CTLA-4OX-40CD137) drugs, peptide/mRNA neoantigen Immunotherapy and cell therapy; 7. Ability to follow research protocols and follow-up procedures; 8. To be able to and willing to give witnessed written informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation woman; 2. Patients with known or suspected autoimmune disease or other complicated immune system disease; 3. Systemic cytotoxic chemotherapy or experimental drugs within 4 weeks prior to first dose of personalized neoantigen vaccine (not including EGFR-TKI); 4. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of personalized neoantigen vaccine; 5. Patients with liver and kidney dysfunction, severe heart disease, coagulation dysfunction and hematopoietic impairment; 6. Patients with systemic infections; 7. Influence the compliance of the patients; 8. Any disease, treatment, laboratory examination abnormality or medical history that may affect the results of this study or affect the participants' inability to participate in the entire study, or the researchers believe that such subjects are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;feasibility; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological indexes;Tumor markers;ECOG score;Progression-free survival;:Overall survival; | — |
Countries
China
Contacts
Public ContactXueming Du
Tianjin Beichen Hospital
Outcome results
None listed