Liver Cancer, Pancreatic Adenocarcinoma
Conditions
Brief summary
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
Interventions
BIOLOGICALautologous gp96 vaccination
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Sponsors
Chinese Academy of Medical Sciences
Cure&Sure Biotech Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to read and understand the informed consent document; must sign the informed consent; 2. Aged 18 to 75 years old , sex is not limited; 3. Pancreatic cancer or primary liver cancer,must have undergone radical resection; 4. Availability of at least 0.5 g tumor sample; 5. Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation; 6. Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment； 7. ECOG ≤1；life expectancy of at least 12 weeks 8. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs); 9. Agree to Surgical indications of Heart & lung and without the coagulation system disease; 10.Negative pregnancy test for female patients of childbearing potential; 11.Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration.
Exclusion criteria
1. Unable to get the informed consent ; 2. Patient not suitable for radical resection; 3. Patients with active liver disease； 4. Did not get enough tumor tissue ; 5. Progression prior to vaccination as determined by the Principal Investigator; 6. Rreceiving other anti-cancer therapy at the same time; 7. Patient with allergic constitution; 8. Unstable or severe intercurrent medical conditions; 9. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection; 10. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids; 11. Any other cilical trials within 30 days pre-vaccination; 12. Female patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| electrocardiogram | baseline | electrocardiogram test within 3 days before first vaccination |
| blood count | baseline | blood count within 3 days before first vaccination |
| blood chemistries | baseline | blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], serum alanine amino transferase \[ALT\], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen\[BUN\], serum creatinine, serum total protein and serum albumin) within 3 days before first vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in antigen specific T cells | baseline and within 3 days before the 6th injection | tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. |
| Disease-free survival | up to 3 years | — |
| overall survive | up to 3 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in subpopulation of CD8+ T cells at the end of vaccination | within 3 days before the first vaccination, within 3 days after the 6th vaccination | analysis of the expression of CCR7 & CD45RA of CD8+ T cells by FCM within 3 days before first vaccination and within 3 days after the 6th vaccination. |
Countries
China
Outcome results
None listed