Advanced malignant solid tumor
Conditions
Interventions
Vaccine case series:Neoantigen-pulsed dendritic cell vaccines
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged between 18 and 75; 2)The ECOG score is 0 or 1; 3) The expected life expectancy of the patient is greater than 6 months; 4) Patients voluntarily participated in the study and have signed informed consent with good compliance; 5) Patients who were diagnosed as moderate and advanced malignant solid tumor confirmed by histopathology, that is, patients with tumor recurrence, progression or metastasis after the failure of conventional chemotherapy;6) The patient had at least one measurable lesion can be measured(RECIST 1.1; Including measurable and unmeasurable lesions); 7) After antigen prediction and validation by whole exome sequencing and transcriptome sequencing, the tumor tissue of the patient has a viable neoantigen that is feasible for subsequent treatment;8) Not complicated with other malignant tumor, serious autoimmune disease or congenital immune deficiency, advanced serious infection, brain neurological disorder or mental disease; 9) Laboratory tests should meet the following criteria : a) blood routine: White blood cell (WBC) = 3.5×109/L, platelet (PLT) = 100×109/L, neutrophil (ANC) = 1.5×109/L, hemoglobin (HGB) = 100g/L; b) Liver and kidney function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=2.5 (ULN) upper limit of normal value (if abnormal liver function is mainly caused by tumor invasion, it can be =5 (ULN) upper limit of normal value), total bilirubin (TBIL) =1.5×ULN, serum creatinine =1.5×ULN. c) Coagulation function: International standardized ratio (INR) or prothrombin time = 1.5×ULN, activated partial thrombin time (APTT) = 1.5×ULN, unless subject receives anticoagulant therapy, as long as PT or PTT is within the range expected under anticoagulant therapy; d) HIV antibody negative; 10) Electrocardiogram was basically normal, hemodynamic stability was good, left ventricular ejection fraction (LVEF) =50%; 11) Adequate venous access for venous blood, and no other contraindications for leukocyte separation; 12) Female subjects must take effective contraceptive measures throughout the study period; Serum or urine pregnancy test must be negative during screening and throughout the study period and must be non-lactating; Male patients must take contraceptive measures throughout the study period and six months after the study period; 13) Based on the discussion and analysis of the general physical condition of the patient, the researchers concluded that the benefits of participating in the clinical trial exceeded the risks.
Exclusion criteria
Exclusion criteria: 1) Pathological examination suggested malignant tumor with T cell origin or other malignant tumors requiring active treatment. Exceptions include early stage tumors (carcinoma in situ or stage I tumors) that have received radical treatment, basal cell carcinomas of the skin, squamous cell carcinomas of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast that have received potentially radical treatment; 2) Patients with organ failure, including patients with heart failure grade ? and grade ?, patients with renal failure or uremia, patients with respiratory failure or disturbance of consciousness; 3) Patients who are receiving systemic hormone therapy or any other form of immunosuppressive therapy within 3 days prior to first administration of immunotherapy; 4) Patients who have any active autoimmune disease or a history of autoimmune disease or have congenital or acquired immune deficiency, active hepatitis such as active hepatitis B (HBV-DNA=2000 copy number/mL) or hepatitis C; 5) Patients who have uncontrolled active infections; 6) Patients who are participating in or have participated in other clinical trails within 4 weeks prior to first administration; 7) Previous allogeneic tissue/organ transplantation; 8) Patients with history of severe vaccine allergies or have received live vaccines within 3 weeks before the first trial administration. Inactivated virus vaccines for seasonal influenza and injectable inactivated virus vaccine are allowed, but live attenuated influenza vaccines for nasal use are not allowed; 9) Patients who suffer from mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., and cannot comply with the research treatment and monitoring requirements; 10) Patietns with poor compliance and cannot cooperate with clinical trails; 11) Pregnant and lactating women; 12) Prior treatment with steroid drugs such as dexamethasone within 1 month; 13) Mutations in related functional genes lead to inactivation of tumor antigen delivery pathway and other important immune-related pathways; 14) Other circumstances that the investigator considered not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Quality of Life, QOL; | — |
Countries
China
Contacts
Public ContactHao Chunyi
Outcome results
None listed