Pancreatic caner
Conditions
Interventions
Dose escalation cohorts:PCNAT-01 vaccine was administered with PCNAT-01 vaccine in adult subjects who had completed radical resection of pancreatic tumors and adjuvant therapy using a "3 3" dose escal
Expand the queue:Tumor personalized vaccine:Dose of 600ug per peptide for treatment
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Underwent radical resection of pancreatic cancer and was pathologically assessed to have an R0 or R1 status; 2.Pathologically diagnosed with stage I/II/III pancreatic cancer; 3.Male or female aged >=18 and <=75 years; 4.Agree to use effective birth control during treatment and for at least 6 months after the last study treatment; 5.Agree to follow the study protocol treatment, laboratory testing and required visit schedule; 6.According to the investigators, the expected survival is not less than 6 months.
Exclusion criteria
Exclusion criteria: 1.Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study; 2.Exist serious postoperative complications; 3.Received antitumor therapy not specified in the protocol, including any investigational drugs, biotherapeutics, immunotherapy, radiotherapy or hormone therapy, and other drugs with immunomodulatory effects, during the period 21 days prior to the first administration of the study drug through the final administration of the study drug; 4.Systemic infections requiring intravenous antibiotics developed within the first 2 weeks of drug use were appeared; 5.A history of severe cardiovascular disease, including left ventricular ejection fraction (LVEF) = Grade 2 (New York Heart Association), acute myocardial infarction, angina, uncontrolled arrhythmia, acute coronary syndrome, stent placement, stroke, or transient ischemic attack (TIA); 6.Hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg) poorly controlled by two antihypertensive drugs and type 2 diabetes (fas;ting blood glucose >=8.9 mmol/L) or diabetic neuropathy not controlled by hypoglycemic therapy; 7.Uncontrolled autoimmune disease, or a history of organ transplants; 8.Have an immune deficiency or require other chronic immunosuppressive therapy; 9.Patients with a clear history of allergy may have an underlying allergy or intolerance to tumor personalized vaccines and adjuvants; 10.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA>=500 IU/ml), hepatitis C, active tuberculosis; 11.ECOG physical strength score > 1; 12.Did not receive adjuvant chemotherapy after surgery; 13.Postoperative toxicity associated with adjuvant chemotherapy did not return to baseline (pre-operative level) or grade 1 or lower, except for hair loss; 14.The level of organ function does not meet the requirements; Laboratory tests are classified by system: Haematology Absolute neutrophil count >= 1.5×10^9/L Platelet count >= 90×10^9/L Hemoglobin >= 9 g/dL or >=5.6 mmol/L Liver function Total bilirubin = 3.5 g/dL Kidney function Serum creatinine or estimated creatinine clearance*= 50 mL/min Coagulation function Prothrombin time Thromboplastin time <= 1.5 × upper limit of normal 15.Recurrence or metastasis before the first dose of vaccine; 16.Other malignancies within the previous 5 years, except locally curable cancers that have undergone radical treatment, such as skin basal cell carcinoma, superficial bladder carcinoma, breast carcinoma in situ, and cervical carcinoma in situ; 17.In the investigator's judgment, there are other diseases or other conditions that are not suitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Vital Signs;ECG indicators;ECOG performance status;Injection Site Evaluation; | — |
Countries
China
Contacts
Public ContactGang Jin
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed