Phase
Condition
Neoplasms
Treatment
Neoantigen peptide vaccine
Neoantigen-based DC immune preparation
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
With inoperable advanced malignant solid tumors, including melanoma,gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lungcancer, etc.
Failed in standard treatment or voluntarily give up other treatment, and been longerthan 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 planwithin 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 oflymphocytes > 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
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 boweldisease, 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 aschronic obstructive pulmonary disease), as well as topical steroids
With uncontrollable epilepsy, central nervous system disorder, or neurologicaldisease 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 whohave been clinically cured, and squamous cell carcinoma or skin basal cellcarcinoma)
Those the researcher believed inappropriate to participate in this study
Study Design
Study Description
Connect with a study center
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
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