Pancreatic Neoplasms
Conditions
Keywords
mix vaccine, pancreatic neoplasms, immunotherapy
Brief summary
The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.
Detailed description
In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression. Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.
Interventions
BIOLOGICALMV
MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
OTHERStandard Treatment
Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 1.Patients diagnosed with pancreatic carcinoma based on histology * 2.Evaluable lesions on imaging study * 3.Without known immunodeficiency * 4.Age \>18 and \<80 years ago
Exclusion criteria
* 1.Patients is unable or unwilling to sign informed consent * 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * 3.Positive HIV and/or RPR (rapid plasma reagin) * 4.Female patient who is pregnant or breast feeding * 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study * 6.Prior anti-cancer vaccine or biological immunotherapy * 7.Allergic to any known ingredient of the MV compound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria | 1 month | — |
| immunology index | 2 years | including lymphocyte subtype number and function, cytokines |
Countries
China
Outcome results
None listed