Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection

Korábbi kezelés

• Patients are unable to tolerate surgery and adjuvant therapy or patients with poor immune system status;
• Received other systemic antitumor agents or systemic glucocorticoids with immunosuppressants;
• Received other vaccine inoculation 4 weeks before treatment;
• With HIV, HCV, HBV infection, severe asthma, autoimmune disease,immunodeficiency or treated with immunosuppressive drugs;
• Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;

Más betegség

• Diagnosed as other malignant tumor;
• Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
• Infected with herpes virus (except those with scabs of more than 4 weeks);
• Infected with respiratory virus (except those who have recovered for more than 4 weeks);
• Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
• Have a history of drug or vaccine allergies, or people who are allergic to other potential immunotherapies;

Egyéb

• No neoantigen was found in the sequencing data;
• There have been bone marrow or stem cell transplants;

• Must freely sign informed consent;
• Aged 18 to 80 years old;
• Histologically or cytologically confirmed diagnosis of esophagus cancer;
• ECOG score is 0 or 1;
• completed Neoadjuvant combined with PD-1 therapy ;Completed surgical resection ;At the same time, standard postoperative treatment was performed 8 ~ 12 weeks of therapy;
• Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
• Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
• Haematological index： White blood cells ≥ 3500 / MCL; Lymphocytes > 800/ MCL; neutrophils > 1500/ MCL; Platelets > 100000 / MCL; Hemoglobin >10.0g/dL; Total serum bilirubin <1.5× upper limit of normal value (ULN); AST/ALT<2.0 times the upper limit of normal; Serum creatinine <1.5 times the upper limit of normal；
• 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;
• Male patients are willing to take appropriate methods of contraception;
• Good compliance, able to follow research protocols and follow-up procedures;