Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events related to gp96 immunotherapy
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
- •Able to read and understand the informed consent document, must sign the informed consent
- •Age: 18 to 75 years old
- •Availability of at least 0.5 g tumor sample
- •ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures
- •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)
- •Normal heart function
- •NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.
排除标准
- •Unable to get the informed consent
- •Female patients who are pregnant or breastfeeding
- •Progression prior to treatment as determined by the principal investigator
- •Transplant recipient
- •Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
- •Unstable or severe intercurrent medical conditions
- •Patient with allergic constitution
- •Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
研究组 & 干预措施
gp96 group
autologous gp96 vaccination + basal treatment for gastric cancer
干预措施: autologous gp96 vaccination (Biological)
gp96 group
autologous gp96 vaccination + basal treatment for gastric cancer
干预措施: Oxaliplatin+S-1 (Drug)
control group
Oxaliplatin+S-1
干预措施: Oxaliplatin+S-1 (Drug)
结局指标
主要结局
Number of participants with adverse events related to gp96 immunotherapy
时间窗: participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.
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.
Disease free survival
时间窗: 2 years
次要结局
- Overall survival(3 years)
- Changes in antigen specific T cells(within 3 days before the first vaccination and within 3 days after the 10th vaccination)
研究者
Lin Chen
Director of the general surgery department
Chinese PLA General Hospital