tumor
Conditions
Interventions
group one:neoantigen peptide vaccine therapy
Sponsors
The First Affiliated Hospital of Air Force Medical University/National Clinical Research Center for Digestive Diseases
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 and = 75 , ECOG score 0-1, estimated survival time = 6 months 2. Stage III tumor patients with high-risk factors or stage IV tumor patients with failed multi line treatment after surgical treatment 3. Sufficient fresh or paraffin embedded tumor tissue can be obtained through biopsy or surgery before receiving treatment 4. Patients need to meet the following hematological indicators: a) Lymphocyte count = 0.8 × 109/L, neutrophil count = 1.5 × 109/L b) Hemoglobin = 9g/dL c) Platelet count = 90 × 109/L 5. Patients need to meet the following biochemical indicators: a) Total bilirubin = 1.5 × Upper limit of normal value (ULN) b) AST and ALT<1.5 × ULN c) Creatinine clearance rate = 60ml/min 6. Patients need to meet the following coagulation indicators: INR or PTT = 1.5 × Upper limit of normal value (ULN) 7. Signed informed consent form 8. Able to follow the research protocol and follow-up process
Exclusion criteria
Exclusion criteria: 1. Patients with autoimmune diseases or immune deficiencies who use immunosuppressive drugs for treatment 2. Uncontrollable accompanying diseases, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, and arrhythmia; Uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease, or other diseases that researchers believe are not eligible for inclusion 3. Accompanying HIV infection or active hepatitis B, HBV (HBV DNA = 500IU/ml), hepatitis C 4. Pregnant and lactating women 5. Within 4 weeks before the first administration or within 8 weeks of the last vaccination during the study period, other preventive vaccines are planned to be administered 6. Individuals who have experienced severe allergic reactions due to previous vaccination against other infectious diseases 7. Individuals who may be allergic to the study drug or any of its excipients 8. Those who cannot receive vaccine treatment due to social or geographical factors 9. Any uncertain factors that affect the safety or compliance of patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; overall survival; | — |
Countries
China
Contacts
Public ContactHongmei Zhang Yongzhan Nie
The First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed