Overview

Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese PLA General Hospital
Collaborator:
Cure&Sure Biotech Co., LTD
Treatments:
Oxaliplatin
Vaccines
Criteria
Inclusion Criteria:

1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage
III (according to the Japanese gastric cancer classification), must have undergone
radical resection

2. Able to read and understand the informed consent document, must sign the informed
consent

3. Age: 18 to 75 years old

4. Availability of at least 0.5 g tumor sample

5. ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures

6. 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)

7. Normal heart function

8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

1. Unable to get the informed consent

2. Female patients who are pregnant or breastfeeding

3. Progression prior to treatment as determined by the principal investigator

4. Transplant recipient

5. Patients currently diagnosed with Human Immunodeficiency Virus or other active
uncontrolled infection

6. Unstable or severe intercurrent medical conditions

7. Patient with allergic constitution

8. Patients with any systemic disease needed to be treated with immunosuppressant or
Corticosteroids.