MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
Trial ID: NCT04216550
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2018-01-01
Completion date: 2025-06-01
Sponsor: The First Affiliated Hospital of Zhengzhou University
Conditions: Recurrent Glioma
Interventions: Apatinib
Locations: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
Countries: China
Enrollment: 600
Age range: 18 Years - 90 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions.
2. With measurable or evaluable disease defined by RANO criteria by MRI scan.
3. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
4. Life expectancy ≥3 months.
5. No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.
6. No history of serious hypertension disease.
7. 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.
8. With written informed consent signed voluntarily by patients themselves.

Exclusion Criteria:

1. Patients with age\<18 or \>90 years.
2. Pregnant or lactating women.
3. Inadequately controlled hypertension (defined as systolic blood pressure \> 140 and/or diastolic blood pressure \> 90 mmHg on antihypertensive medications).
4. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
5. Factors that could have an effect on oral medication.
6. Abnormal Coagulation (international normalized ratio\>1.5, prothrombin time\>UNL+4s,activated partial thromboplastin time\>1.5 UNL), with tendency of bleeding.
7. Currently receive thrombolytic and anticoagulation therapy
8. History of pneumorrhagia(CTCAE grade ≥2 ) or other parts hemorrhage(CTCAE grade ≥3 ) within 4 weeks prior to treatment.
9. 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.
10. 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.

Outcomes:
Changes of Response to Treatment