Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
PhasePhase 1/Phase 2
Lead SponsorCure&Sure Biotech Co., LTD
Indication/ConditionLiver Cancer Pancreatic Adenocarcinoma
Intervention/Treatmentautologous gp96 vaccination ...
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
vaccination of autologous gp96 derived from tumor tissue + basal treatment
autologous gp96 vaccination + basal treatment
Inclusion Criteria: Able to read and understand the informed consent document; must sign the informed consent; Aged 18 to 75 years old , sex is not limited; Pancreatic cancer or primary liver cancer,must have undergone radical resection; Availability of at least 0.5 g tumor sample; Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation; Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment； ECOG ≤1；life expectancy of at least 12 weeks 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: Unable to get the informed consent ; Patient not suitable for radical resection; Patients with active liver disease； Did not get enough tumor tissue ; Progression prior to vaccination as determined by the Principal Investigator; Rreceiving other anti-cancer therapy at the same time; Patient with allergic constitution; Unstable or severe intercurrent medical conditions; Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection; Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids; Any other cilical trials within 30 days pre-vaccination; Female patients who are pregnant or breastfeeding.