Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03171220
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged 18 to 75 years old
* Histologic or cytologic confirmation of advanced refractory solid tumors with no available curative treatment options
* At least one measurable disease: diameter ≥20mm or spiral computed tomography(CT)≥10mm; and can providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes)
* Must be human leukocyte antigen (HLA)-A2/A24/A11 positive
* Eastern Cooperative Oncology Group(ECOG)\<0-2 and expected survival time 3 months or more
* At least one new antigen can induce T cell secrete interferon - gamma (IFN - gamma) twice as normal controls during the new antigens screening
* Without anticancer treatment more than one month
* Hematology Index including: Neutrophile granulocyte greater than 1.5×10\^9/L; Hemoglobin greater than 10g/dL; Platelet greater than 100×10\^9/L
* Biochemical index including: Serum bilirubin not greater than 1.5x upper limit of reference range (ULN); glutamic-pyruvic transaminase（ALT） or glutamic-oxalacetic transaminase（AST） not greater than 2.5x ULN; Creatinine clearance no less than 60ml/min
* Peripheral venous channel open and no contraindications to separating lymphocytes
* Negative pregnancy test for women of childbearing potential, and patients must be willing to practice birth control during the regimen
* Provision of informed consent
* Be able to follow the research program and follow up process
Exclusion Criteria:
* Those who now are undergoing other antitumor drug therapy (including chemotherapy, systemic steroids therapy, surgery, target therapy or immune therapy);
* Prior treatment with PD-1 monoclonal antibody(mAb） or PD-L1 mAb;
* Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix;
* History with pulmonary tuberculosis, and positive tests for Acquired Immune Deficiency Syndrome(HIV),hepatitis C virus(HCV),hepatitis B virus(HBV);
* Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism; Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure \> class II New York Heart Association(NYHA), heart block \>II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm).
* Evidence with central nervous system(CNS) disease
* Pregnant or nursing
* Psychiatric medicines abuse without withdrawal, or history of psychiatric illness.
* Hypersensitivity to investigational drugs or its components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03171220
Study Brief:
Protocol Section:
NCT03171220