Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The percentage of patients who accomplish the recommended regimen for at least 1 course.
研究概览
简要总结
This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.
详细描述
The investigators have established a precision treatment strategy, that select chemotherapeutic drugs or targeted drugs based on information from PTCs drug-screening or/and bioinformatic prediction. In this study, the investigators are going to exploit this strategy for the precision treatment of recurrent high-grade gliomas. The investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, clinical assays, KPS, neurological score, etc.
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
- •1 At the age of 18~75, regardless the gender
- •2 The lesion of primary surgery was diagnosed as WHO II~IV Glioma by histologic pathology
- •3 Received radiotherapy and Temozolomide-based chemotherapy within 5 years
- •4 Recurrent and respectable gliomas, and have been neurosurgically resected
- •5 The resected recurrent gliomas was identified as WHO III~IV Glioma by histologic pathology
- •6 None postoperative standard therapeutic regimens can be followed when participating the recruitment
- •7 Can understand the trial's content and sign informed consent
排除标准
- •1 Having other untreated malignant tumors
- •2 The amount of resected tumors is not enough for genomic sequencing or PTCs drug screening
- •3 Received Carmustine implants within 6 months prior to enrollment
- •4 Subjects with active HBC, HCV or HIV infection
- •5 Subjects with uncontrolled cardio- or cerebro- vascular diseases
- •6 Subjects with uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes
- •7 Subjects with other conditions in their active phase that would interfere trial participation
- •8 Subjects receiving immunosuppressants after organ transplantation
- •9 Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment, or receiving anticoagulant therapy
- •10 Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment
- •11 Subjects with other conditions that would interfere participating in the trial at the investigator's discretion
- •12 Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures
研究组 & 干预措施
Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
These drugs included all the FDA-approved drugs that have been used in treating gliomas. A single drug or a drug combination for a specific patient will be recommended by the molecular tumor board, comprising neurooncologists, neurosurgeons, pharmacologists, cancer biologists, radiologists and bioinformaticians, will recommend , based on their expertise, patients willingness as well as evidences from PTCs-drug screening and bioinformatic prediction for drug response.
干预措施: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. (Drug)
结局指标
主要结局
The percentage of patients who accomplish the recommended regimen for at least 1 course.
时间窗: 24 months
次要结局
- Progression-free survival (PFS)(24 months)
- Overall survival (OS)(24 months)
- Incidence of Treatment-Emergent Adverse Events (AEs)(From the first shot to 4 weeks after the last shot)
- Ratio of 6 months overall survival (OS)(6 months)
- Ratio of 12months overall survival (OS)(12 months)
研究者
Yang Zhang
Ph.D. & M.D.
Beijing Tiantan Hospital