Gastric Carcinoma Clinical Trial
Official title:
Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | Cure&Sure Biotech Co., LTD |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | 2 years | No | |
Primary | Number of participants with adverse events related to gp96 immunotherapy | A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason. And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 3.0 criteria. |
participants will be followed from the day of the first vaccination to the 30th day after the last vaccination. | Yes |
Secondary | Changes in antigen specific T cells | Tumor antigen specific T cells will be determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. | within 3 days before the first vaccination and within 3 days after the 10th vaccination | No |
Secondary | Overall survival | 3 years | No |
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