NCT04206254Unknown2 期
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
Cure&Sure Biotech Co., LTD0 个研究点目标入组 80 人开始时间: 2019年12月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 主要终点
- 2-year recurrence-free survival rate
研究概览
简要总结
This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
详细描述
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Able to read and understand the informed consent document; must sign the informed consent;
- •Aged 18 to 75 years old , sex is not limited;
- •must have undergone radical resection;AJCC TNM II、III、IV.
- •Availability of at least 1g tumor sample;
- •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 adequate renal function (BUN and creatinine <1.5 times IULNs)
- •Agree to Surgical indications of Heart & lung and without the coagulation system disease
- •Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；
排除标准
- •Inability to comply with study-related procedures
- •Unavailability of at least 6 doses of vaccine
- •Severe allergies
- •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.
- •Female patients who are pregnant or breastfeeding
- •Steroidal drugs are currently being used systemically.
结局指标
主要结局
2-year recurrence-free survival rate
时间窗: 2 year
次要结局
- Disease free survival(5 year)
- changes in antigen specific T cells(within 3 days before the first vaccination and within 10 days after the last vaccination)
- Number of participants with adverse events related to gp96 immunotherapy(up to 3 months after vaccine completion)
- Overall survival(5 year)
研究者
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