Official Title

Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

    Unknown status
  • Study Participants

To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
Study Started
Mar 31
Primary Completion
Nov 30
Study Completion
Nov 30
Last Update
Dec 11

Biological autologous gp96 vaccination

vaccination of autologous gp96 derived from tumor tissue + basal treatment

gp96 group Experimental

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.
No Results Posted