NCT02133079Unknown1 期
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
Cure&Sure Biotech Co., LTD2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- blood count
研究概览
简要总结
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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);
- •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.
排除标准
- •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.
结局指标
主要结局
blood count
时间窗: within 3 days after the 6th injection
blood count within 3 days after the 6th injection
blood chemistries
时间窗: within 3 days after the 6th injection
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
electrocardiogram
时间窗: within 3 days after the 6th injection
electrocardiogram test within 3 days after the 6th injection
次要结局
- Disease-free survival(up to 3 years)
- overall survive(up to 3 years)
- changes in antigen specific T cells(baseline and within 3 days before the 6th injection)
研究者
研究点 (2)
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