Gastric cancer/Hepatic Carcinoma
Conditions
Interventions
Case series:Nanovaccine + Cyclophosphamide
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 6 months or more; 2. Histologic confirmation of advanced gastric cancer or heptocellular carcinoma. The patients were given at least for 4 cycles adjuvant chemotherapy within 8 weeks post surgery. Otherwise, patients were not willing receive chemotherapy after knowing the advantages and disadvantage; 3. Patients without measurable lesions after surgery, and stage IIIB,IIIC and IVA for gastric cancer, stage III for heptocellular carcinoma(AJCC 8th); 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. Any chemotherapy, radiotherapy of immunotherapy with experimental drug within 2 months before the first dose of vaccine therapy; 2. 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; 3. 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; 4. Patients with HIV infection, active HBV infection(HBV DNA=500IU/ml),HCV infection; 5. serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group; 6. Uncontrolled intercurrent illness including, but not limited to ongoing or active bacterial or fungal infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; 7. Active, known, or suspected autoimmune disease or use immunosuppressive treatment; 8. Women who are pregnant or breast feeding; 9. 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; 10. History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases; 11. May be allergic to immunotherapy; 12. Drug abuse, clinical or psychological or social factors which will influence the informed consent or the study implementation; 13. Weight loss greater 10% within 6 weeks before the start of study therapy; 14. influence the safety or compliance of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunology indexes;recurrence-free survival;overall survival;life quality; | — |
Countries
China
Contacts
Public ContactLiu Baorui
The Affiliated Drum Tower Hospital to Medical School of Nanjing University
Outcome results
None listed