NCT05749627 Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2023-04-01 with a primary completion date of 2025-12-31.

Brief Summary

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.

Eligibility Criteria

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 treatment * Had disease progression prior to treatment * Expected survival ≥ 3 months * ECOG performance status of 0, 1, or 2 * With a negative pregnancy test for females of childbearing age * Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study * Not positive for HIV, HBV, HCV, or TP * ALT/AST ≤ 2.5 times the upper limit of normal * ALP ≤ 2.5 times the upper limit of normal * Serum creatinine ≤1.6 mg/dL * Total bilirubin ≤ 1.5 mg/dL * In 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/μL * With normal coagulation test and ECG * Able to understand and willing to sign a written informed consent form Exclusion Criteria: * 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 * With severe allergies or histories of severe allergy * With splenectomy * 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.) * 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 * With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability * With a history of chronic alcohol or drug abuse within 6 months * 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.) * 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

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