MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Changes of Response to Treatment
研究概览
简要总结
Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas.
详细描述
Effective treatment for recurrent gliomas is still challenging. Malignant gliomas are considered to be one of the most angiogenic cancers and are mostly sustained by vascular endothelial growth factor (VEGF) signaling via its endothelial tyrosine kinase receptor VEGF receptor 2 (VEGFR-2). Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits VEGFR-2. Apatinib has been demonstrated as monotherapy that prolongs OS in patients with gastric cancers after two or more lines of chemotherapy with moderate, reversible, and easily managed adverse effects. This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study also seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas. The creation of a registry for patients with recurrent gliomas treated by Apatinib with detailed survival data, radiological data, histopathology image data and with sufficient sample size for artificial intelligence provides opportunities for personalized prediction of responses to Apatinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions.
- •With measurable or evaluable disease defined by RANO criteria by MRI scan.
- •Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- •Life expectancy ≥3 months.
- •No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.
- •No history of serious hypertension disease.
- •Patients have adequate organ function as defined by the following criteria:
- •Hemoglobin (HGB) ≥90g/L
- •Absolute neutrophil count (ANC) ≥1.5×109/L
- •White blood cell (WBC) ≥3.0×109/L
- •Platelet count ≥80×109/L
- •Alanine aminotransferase(ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis
- •Creatinine (Cr) of ≤1.25 UNL or creatinine clearance(Ccr) > 45 ml/min.
- •With written informed consent signed voluntarily by patients themselves.
排除标准
- •Patients with age<18 or >90 years.
- •Pregnant or lactating women.
- •Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications).
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •Factors that could have an effect on oral medication.
- •Abnormal Coagulation (international normalized ratio>1.5, prothrombin time>UNL+4s,activated partial thromboplastin time>1.5 UNL), with tendency of bleeding.
- •Currently receive thrombolytic and anticoagulation therapy
- •History of pneumorrhagia(CTCAE grade ≥2 ) or other parts hemorrhage(CTCAE grade ≥3 ) within 4 weeks prior to treatment.
- •History of artery thrombosis and phlebothrombosis, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 6 month prior to treatment.
- •Medical history of clinically significant thrombosis (bleeding or clotting disorder), excluding warfarin(1mg po qd) and aspirin(80-100mg po qd) for prevention under INR≤1.5.
研究组 & 干预措施
Apatinib
Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death
干预措施: Apatinib (Drug)
结局指标
主要结局
Changes of Response to Treatment
时间窗: From enrollment to progression of disease. Estimated about 6 months
Response were evaluated with Response Assessment in Neuro-Oncology (RANO) criteria every 1 month after treament.
次要结局
- Progression-Free Survival (PFS)(From enrollment to progression of disease. Estimated about 6 months.)
- Overall Survival (OS)(From enrollment to death of patients. Estimated about 1 year.)
- Incidence of treatment-related adverse events(Time Frame: 0 to 1 year)
研究者
Zhenyu Zhang
Principal Investigator
The First Affiliated Hospital of Zhengzhou University