In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-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.
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 treatment
Had disease progression prior to treatment
Expected survival ≥ 3 months
Pregnant or breastfeeding women
Patients with brain metastases
Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months
Participated in other clinical study within 30 days
Single group
Neoantigen peptide vaccine
DrugPersonalized tumor neoantigen peptide vaccine
Neoantigen-based DC immune preparation
DrugPersonalized tumor neoantigen DC therapeutic immune preparation
Progression-free survival
Progression-free survival (PFS) is the time from the inoculation of the individualized neoantigen immune preparation to disease progression or death from various causes for all patients. Tumor assessment is performed according to the RECIST1.1 standard. The analysis of this indicator includes results of tumor assessments performed during the treatment period and the follow-up period. If a patient has several indicators that can be judged as disease progression (PD), the indicator that appears first will be used for PFS analysis. Relapse, new tumors, or death are considered to have reached the end of the study. For patients who had not experienced disease progression at the end of the study, the last time the patient had no disease progression was used as censoring data.
Overall response rate
Overall response rate is the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the objective response of tumors. Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation is divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Tumor makers
CEA，CA19-9，CA125
Overall survival
Overall survival is the time from inoculation of the individualized neoantigen immune preparation to death due to various causes for all patients.
Disease control rate
Disease control rate is the percentage of patients who have a complete response (CR), partial response (PR), and stable disease (SD) to the treatment.
Tumor imaging
CT/MRI scan, X-ray examination etc.
Peripheral blood cytokines
Changes in peripheral blood cytokines after treatment, including IFN-γ, TNF, IL-2, etc.
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The First Affiliated Hospital of Nanchang University
Lead sponsor
Shanghai Dengding BioAI Co.
Collaborator
