Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-related Adverse Events
研究概览
简要总结
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.
详细描述
High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, there is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed glioma
- •Participants had undergone maximal surgical resection
- •Amount of dexamethasone was not more than 2mg/ days
- •Ability and willingness to sign informed consent
- •Karnofsky Performance Score of 70 or more
- •Normal liver and kidney function
- •Not accepted other treatment plan during the immunotherapy
排除标准
- •Not conforming to the standard
- •Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- •Received other drugs for glioma therapy 60days before participated
- •Allergy to immune adjuvant
- •Nervous system disease and diffuse leptomeningeal disease
- •Amount of dexamethasone was more than 2mg/days during the immunotherapy
- •Pregnant or lactation
研究组 & 干预措施
Combined immune adjuvants and radiation
Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed.
干预措施: Combined immune adjuvants and radiation (Combination Product)
结局指标
主要结局
Incidence of Treatment-related Adverse Events
时间窗: 2 years
Adverse events during and after the combined treatment
次要结局
- Progression-free Survival(2 years)
- Overall Survival(2 years)
研究者
Song Lin
MD and Chief Physician
Beijing Tiantan Hospital