[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496852":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":21,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The First Affiliated Hospital of Nanchang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoantigen peptide vaccine\u002Fneoantigen-based DC treatment","EXPERIMENTAL","Patients assigned to the neoantigen peptide vaccine\u002Fneoantigen-based DC treatment group will receive 5-6 subcutaneous injections of neoantigen peptide vaccine or neoantigen-based DC immune preparation within a 14-week treatment period.",[13,14],"Drug: Neoantigen peptide vaccine","Drug: Neoantigen-based DC immune preparation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Neoantigen peptide vaccine","Personalized tumor neoantigen peptide vaccine",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Neoantigen-based DC immune preparation","Personalized tumor neoantigen DC therapeutic immune preparation",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Sujun Li, PhD","CONTACT","8617600699826","17600699826@163.com",{"name":33,"role":29,"phone":21,"phoneExt":21,"email":21},"Aiping Le",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"First Affiliated Hospital of Nanchang University","RECRUITING","Nanchang","Jiangxi","330006","China","CN",{"type":44,"coordinates":45},"Point",[46,47],115.85306,28.68396,{"lat":47,"lon":46},[50,51],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},{"name":33,"role":29,"phone":21,"phoneExt":21,"email":21},{"type":53,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[55],{"name":56,"class":57},"Shanghai Dengding BioAI Co.","UNKNOWN","100496852","using-neoantigen-peptide-vaccineneoantigen-based-dc-to-treat-advanced-malignant-solid-tumors-100496852",false,"NCT05749627","Using Neoantigen Peptide Vaccine\u002Fneoantigen-based DC to Treat Advanced Malignant Solid Tumors","A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine\u002Fneoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.\n* Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment\n* Had disease progression prior to treatment\n* Expected survival ≥ 3 months\n* ECOG performance status of 0, 1, or 2\n* With a negative pregnancy test for females of childbearing age\n* Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study\n* Not positive for HIV, HBV, HCV, or TP\n* ALT\u002FAST ≤ 2.5 times the upper limit of normal\n* ALP ≤ 2.5 times the upper limit of normal\n* Serum creatinine ≤1.6 mg\u002FdL\n* Total bilirubin ≤ 1.5 mg\u002FdL\n* In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes \\> 20%, absolute neutrophil count ≥ 1x10\\^9\u002FL, white blood cell count ≥ 3x10\\^9\u002FL, platelet count ≥ 100×10\\^9\u002FL, hemoglobin \\> 8.0 g\u002FdL, CD4+ cell count \\> 200\u002FμL\n* With normal coagulation test and ECG\n* Able to understand and willing to sign a written informed consent form\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with brain metastases\n* Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months\n* Participated in other clinical study within 30 days\n* With severe allergies or histories of severe allergy\n* With splenectomy\n* With 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.)\n* 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 steroids\n* With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability\n* With a history of chronic alcohol or drug abuse within 6 months\n* With 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.)\n* 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)\n* Those the researcher believed inappropriate to participate in this study","ALL","18 Years","70 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"NA","In this study, the investigators provide a personalized tumor neoantigen peptide vaccine\u002Fneoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators 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.",[76],"Advanced Malignant Solid Tumors",[78,79,80,76,81,82,83],"Neoantigen Peptide Vaccine","Neoantigen-based Dendritic Cells","Therapeutic immune preparation","Progression-free Survival","Overall Survival","Overall Response Rate","2025-02-25",{"date":86,"type":87},"2025-02-27","ACTUAL",{"date":89,"type":87},"2023-04-01",{"date":91,"type":70},"2025-12-31",{"name":5,"class":6},1]