Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma

Official Title
-----------------
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Conditions
-----------------
Liver Cancer, Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Biological: autologous gp96 vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gp96 group<br>autologous gp96 vaccination + basal treatment | Biological: autologous gp96 vaccination<br>* vaccination of autologous gp96 derived from tumor tissue + basal treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood count | blood count within 3 days before first vaccination | baseline | 
| blood count | blood count within 3 days after the second injection | within 3 days after the second injection | 
| blood count | blood count within 3 days after the 6th injection | within 3 days after the 6th injection | 
| blood chemistries | 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 | baseline | 
| blood chemistries | 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 after the second injection | within 3 days after the second injection | 
| blood chemistries | 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 after the 6th injection | within 3 days after the 6th injection | 
| electrocardiogram | electrocardiogram test within 3 days before first vaccination | baseline | 
| electrocardiogram | electrocardiogram test within 3 days after the second injection | within 3 days after the second injection | 
| electrocardiogram | electrocardiogram test within 3 days after the 6th injection | within 3 days after the 6th injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | up to 3 years | 
| overall survive |  | up to 3 years | 
| changes in antigen specific T cells | tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. | baseline and within 3 days before the 6th injection |