Using Neoantigen Peptide Vaccine/Neoantigen-based DC to Treat Advanced Malignant Solid Tumors

In this study, we provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. We observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.

Inclusion Criteria:With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatmentHad disease progression prior to treatmentExpected survival ≥ 3 monthsECOG performance status of 0, 1, or 2With a negative pregnancy test for females of childbearing ageAble to take effective contraceptive measures and ensure that there is no birth plan within half a year of the studyNot positive for HIV, HBV, HCV, or TPALT/AST ≤ 2.5 times the upper limit of normalALP ≤ 2.5 times the upper limit of normalSerum creatinine ≤1.6 mg/dLTotal bilirubin ≤ 1.5 mg/dLIn the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes > 20%, absolute neutrophil count ≥ 1x10^9/L, white blood cell count ≥ 3x10^9/L, platelet count ≥ 100×10^9/L, hemoglobin > 8.0 g/dL, CD4+ cell count > 200/μLWith normal coagulation test and ECGAble to understand and willing to sign a written informed consent formExclusion Criteria:Pregnant or breastfeeding womenPatients with brain metastasesHad immunosuppressant therapy within 1 month or received other immunotherapy within 3 monthsParticipated in other clinical study within 30 daysWith severe allergies or histories of severe allergyWith splenectomyWith primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroidsWith uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive abilityWith a history of chronic alcohol or drug abuse within 6 monthsWith unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)Those the researcher believed inappropriate to participate in this study