Solid Tumors
Conditions
Interventions
Case Series:Nanovaccine
Sponsors
The Affiliated Drum Tower Hospital to Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female or male aged 18 to 75 years,ECOG performance status 0 or 1,Expected survival time 3 months or more; 2. Patients with advanced solid tumors including gastric cancer,colorectal cancer, liver cancer, clear cell cancer, soft tissue sarcoma, esophageal cancer, lung cancer, ovarian cancer, breast cancer, kidney cancer, prostate cancer, melanoma, neuroendocrine tumors, nasopharyngeal cancer or other diseases progressed after standard treatment or recommend clinical trials by the guidelines. Otherwise, patients were not willing receive chemotherapy after knowing the advantages and disadvantage; 3. Patients with at least one measurable lesion for therapeutic evaluation; 4. Absolute lymphocyte count of =0.8×10^9/L,absolute neutrophil count of =1.5×10^9/L,Hemoglobin greater than 10g/dL; Platelet greater than 90×10^9/L; 5. Serum bilirubin not greater than 1.5×upper limit of reference range (ULN); ALT or AST not greater than 1.5×ULN; Creatinine clearance no less than 60ml/min; 6. INR or PTT not greater than 1.5×ULN; 7. Negative pregnancy test for women of childbearing potential; 8. Provision of informed consent; 9. Be able to follow the research program and follow up process.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; 2. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ and basal cell or squamous cell carcinoma of the skin; 3. Patients with HIV infection, active HBV infection (HBV DNA=500IU/ml), HCV infection; 4. serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group; 5. Uncontrolled intercurrent illness including, but not limited to ongoing or active bacterial or fungal infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; 6. Active, known, or suspected autoimmune disease or use immunosuppressive treatment; 7. Women who are pregnant or breast feeding; 8. Use of a non-oncology vaccine therapy for prevention of infectious diseases (up-to) 4 weeks prior to enrollment to the study. Patients may not receive any non-oncology vaccine therapy during the period of nanovaccine administration and until at least 8 weeks after the last dose of study therapy; 9. History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases; 10. May be allergic to immunotherapy; 11. Drug abuse, clinical or psychological or social factors which will influence the informed consent or the study implementation; 12. Weight loss greater 10% within 6 weeks before the start of study therapy; 13. Influence the safety or compliance of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunology indexes;Progress-free survival;Objective reponse rate;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public ContactLiu Baorui
The Affiliated Drum Tower Hospital to Medical School of Nanjing University
Outcome results
None listed