Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Neoantigen, Pancreatic Cancer, iNeo-Vac-P01,Peptide Vaccine Read More

Inclusion Criteria:

• Must freely sign informed consent;
• Aged 18 to 70 years old;
• The expected survival period is more than 6 months;
• ECOG score is 0 or 1;
• Advanced pancreatic cancer diagnosed by Pathology and imageology;
• Tumor cannot be excised by surgery, and multiline chemotherapy, radiation, targeted therapy fails, or other treatments cannot be tolerated;
• At least one measurable lesions;
• To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;
• The main organs function is normal, such as the heart, liver and kidney;
• Haematological index:

neutrophil count≥1.5×10e9/L hemoglobin≥10g/dL platelet count≥100×10e9/L

• Biochemical index:

Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN) AST and ALT is less than or equal to 2.5 times the upper limit of normal value Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value

• Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
• Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

• Diagnosed as other malignant tumor;
• There have been bone marrow or stem cell transplants;
• No neoantigen was found in the sequencing data;
• Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to Individualized tumor targeted polypeptides treatment;
• Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
• Active bacterial or fungal infections identified clinically (>= level 2 of NCI-CTC edition 3);
• Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
• Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
• Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
• Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.